Breast Augmentation Surgery

Any surgery, in any discipline carries a risk of infection. The risk is calculated based on the degree of contamination for a particular operation. Breast augmentation is considered a "clean" surgery, and carries an overall infection rate of less than two percent. If infection should take place, it will most often affect one or more of three patterns, assuming there is no disseminated spread, and the infection remains localized. Infection can occur in the skin, in the soft tissue surrounding the implant, and in the form of a pus pocket. Skin infection will usually respond to oral antibiotics. Soft tissue infections surrounding the breast implant may respond to oral antibiotics, will sometimes require intravenous antibiotics, and in other cases need to be treated with implant removal. If the infection should progress to, or start out as an abscess (pus-pocket), the only treatment that will be effective in treating the infection and preventing more serious systemic complications is drainage of pus and breast implant removal. Toxic Shock Syndrome (TSS) may result from the presence of a foreign body (breast implant in this case) in the setting of an infection, and is a truly life-threatening condition that needs to be addressed immediately. It is marked by high fever, nausea and vomiting, diarrhea, light-headedness and possibly loss of consciousness, and a diffuse rash. The treatment is timely institution of IV antibiotics, and breast implant removal. If the breast implant is removed, the infection should be treated, the inflammation allowed to resolve, and a new implant placed weeks down the road.

Dr. Gerzenshtein’s recommendations to his patients are found below. Consult with your own surgeon for his ore her specific instructions. Do not drive a car or engage in activities that depend on your coordination for 48 hours after your surgery, or after taking any of the pain, nausea or insomnia medications predscribed. Walking and getting about is highly encouraged for multiple reasons, including a decrease in the incidence of clot formation in the veins of your legs, have someone with you for the first 24 hours to monitor and help you get about as necessary. When resting/sleeping, lie on your back with several pillows under your head and back, or place a pillow or rolled blanket under the head of your mattress, this will decrease swelling. You may sleep on your side 2 weeks after surgery, and in any manner 4 weeks after surgery. Do not use your arms in strenuous activity such as vacuuming, pushing yourself up in bed, and pushing yourself up from sitting position for approximately 1 week. For the first week, avoid activities that raise your blood pressure such as heavy manual labor, repeated heavy lifting, strenuous exercise, or bending over. Plan to be away from work for one week, assuming your post-operative course is uncomplicated. After one week you may engage in light exercise only, such as walking. No heavy lifting should be done (10 lbs or more) for 4 weeks after breast augmentation. If weight training, refrain from upper body work for six weeks (substantial capsule formation), otherwise contraction of the pectoralis will push the implant up, changing the position of the final pocket to a more superior and less favorable position. Do not smoke, use nicotine substitutes (patches, chewing tobacco, etc.), and stay away from second hand smoke for at least 6 weeks after surgery. Smoking will decrease blood and oxygen flow to healing tissues and can cause loss (death) of skin, fat, and muscle in the operated field, especially along the incisions, slow down healing to double of normal time, worsen scar appearance on the outside, lead to a tough, fibrous scar on the inside, and increase the risk of fluid pockets.

"Gummy Bear Breast Implants" have the consistency of gummy bears. This means there should be no folding or rippling. Being more formed should presumably allow the implants to maintain a shape closer to the original post-operative contour. Finally, should the implant rupture, migration should not occur to the same degree as with older generation implants.

The main disadvantage to the cohesive "gummy bear" implants is that they require a somewhat larger incision to place. Being more formed does not allow for the kind of manipulation and squeezing through a tight incision that is possible with the older, more liquid-like silicone breast implants. The other drawback is that the gummy bear breast implants only come in the "teardrop," contoured, or shaped variety in the U.S.

Three major factors accounting for significant shape and size changes within the breast need to be considered within each patient. A patient may have one or all three of the components acting to produce undesirable changes in the breasts. The factors are:

• Weight fluctuations, such as large weight-gain followed by a significant loss, stretching out the skin envelope, and then removing the contents (fat).
• Multiple pregnancies acting to increase the volume of breast tissue that pushes on the overlying skin envelope, and atrophies between periods of pregnancy.
• Loss of elasticity in the connective tissue scaffolding that keeps the skin from stretching too far. This may be related to aging, genetics, or both.

Style	Shell Surface	Profile	Fill Volume
68	Smooth	Moderate, Round	120cc-850cc
168	Textured	Moderate, Round	120cc-850cc
163	Textured	Full, Anatomic	195cc-650cc
163 BIOCURVETM	BIOCELL® Textured	Full, Anatomic	360cc-820cc

Style	Shell Surface	Profile	Fill Volume
10	Smooth	Moderate	120cc-800cc
15	Smooth	Mid-Range	152cc-752cc
20	Smooth	High	120cc-800cc
40	Smooth	Moderate	80cc-560cc
45	Smooth	Full	120cc-800cc
110	BIOCELL®Textured	Moderate	135cc-740cc
115	BIOCELL®Textured	Mid-Range	150cc-716cc
110	BIOCELL®Textured	High Profile	180cc-650cc
110	BIOCELL®Textured	Anatomic Dual Lumen	360cc-720cc
110	BIOCELL®Textured	Anatomic	135cc-740cc

There are three non-surgical options available to women who do not wish to undergo breast augmentation surgery. The first is to do nothing and concede to smaller size breasts. The second is to use a padded bra to give the appearance of larger breasts when clothed. The third, though not highly recommended, is to try using a vacuum type device over a several month course.

This decision depends as much on what the surgeon can accomplish using either the round or the anatomically contoured implants as on which type of implants to use.

Assuming the breast pockets are dissected in to the inferior or lowermost extent in the exact same manner, the shaped implants will impart more fullness at the top, and provide a more natural, gently curving slope to the augmented breast. For this to happen, however, the lowermost portion of the dissection or pocket must be the same no matter which mammary implants you use. If a surgeon habitually dissects low enough inferiorly to drop round breast prosthesis low enough that upper pole fullness is lost, that surgeon will likely favor the teardrop shaped, or anatomically shaped implant to compensate for that dissection. For anatomically shaped or contoured implants to do what they were intended for, pocket dissection has to extremely precise. This is because contoured breast implants are not symmetric; they have a top and bottom. If the subglandular or submuscular pockets are too wide, the shaped implants can shift or even flip, imparting asymmetry and even worse an unnatural shape to the augmented breast. Even though shaped mammary implants are textured, this is still no guarantee against malposition. Finally using the round type of breast implants can impart more medial or inner breast fullness. This significantly improves cleavage, because more fill volume winds up toward the more central part of the breast.

The two options available to clients and surgeons in maintaining a comfortable, safe and painless environment for the breast enlargement patient, and a controlled setting for the breast surgeon performing breast enlargement surgery are general anesthesia and intravenous sedation combined with local anesthesia. The advantages of general anesthesia include complete unawareness on the part of the patient during breast implant placement, a secure airway, and a still, controlled environment for the operating surgeon. The greatest disadvantages are post-operative nausea and vomiting, risks associated with general anesthesia and post-operative lethargy that slow recovery. The advantages to sedation type anesthesia for mammary enlargement surgery are just the reverse of the disadvantages noted for general anesthesia; recovery is faster, nausea and vomiting are minimized, and the systemic risks associated with general anesthesia are abolished.

Placing the incision in the axilla (underarm) allows for a smaller incision. It is useful when there is not much breast tissue present to begin with, and thus no prominent breast fold, and when the nipple-areola complex is small. It is not as well concealed as the periareolar incision, gives less control in terms of the ability to feel around the breast pockets in assuring symmetry, and placement of silicone breast implants will necessitate a larger incision which may be less pleasing.

Bleeding is not a common complication after breast augmentation surgery; however, it may lead to problems if not detected in a timely fashion. This applies more to acute hemorrhage immediately after breast enlargement surgery. The affected side would become considerably larger than the non-bleeding side, would possibly turn pale and purplish, and the resulting tension would potentially threaten the viability of the overlying skin. The volume of blood that a breast pocket could potentially accumulate is not large enough to be life-threatening unless combined with certain other conditions. The treatment for acute postoperative bleeding after breast augmentation surgery is an immediate return to the operating room, release of the collected blood, a search for the offending vessel, and control of the bleeder. A hematoma may form after breast augmentation surgery in the case of a slow bleed, not detected immediately, or with subsequent trauma, days, weeks, or months after the initial operation for breast enlargement. The result would be swelling, discoloration, and pain. If large, as judged by the operating surgeon, the collection would need drainage. Smaller hematomas can be absorbed by the body.

Distinguishing native breast tissue from saline breast implants is a necessary part of breast self-examination. It should be fairly obvious to discern breast from implant. If you encounter difficulties, ask your plastic surgeon to demonstrate the appropriate technique for breast self-examination and point out the difference between breast implants and breast tissue.

To understand how the breast is built, we must examine its scaffolding, and then add intervening components. Let’s pretend we are building breasts. First we’ll start by making the skin on the chest wall loose, in a manner of a conical tent. We will make it as loose as we need to fill it with the volume we desire. Then, we’ll build the scaffold. Picture branching lines of connective tissue (white, fibrous, scar like strands) that attach the covering of the chest wall muscle to the overlying skin. Now if you were to tent up on the loose skin in the center of the breast, the scaffold would only allow you to stretch to the limits of it length. This is what would limit the descent of your breasts via gravity, though eventually the scaffold would stretch, and cause sagging breasts. Tenting the scaffolding would also make spaces between its individual strands. The spaces will then be filled with breast parenchyma, or the breast tissue that is responsive to female hormones, produces secretions, swells with monthly cycles, and makes milk. Each segment of this breast tissue will then have a pipe to drain its secretions, or milk. The pipes would travel to the nipple, and get bigger, the nearer to the nipple they came as more pipes joined in from other parts of the breast, and would look like an upside down tree. Finally, a several centimeter layer of fat would be placed under the skin, between the breast parenchyma (tissue), and the skin. The thickness of the fatty padding would depend on the bodyfat composition of the recipient of our breast.

Breast implantation stretches the skin envelope of the breast. This can accentuate stretch marks. Over time, breast skin can thin, revealing breast implant irregularities and fold flaws. The additional weight can potentially lead to an increase in breast drooping, and necessitate breast lifting or tightening.

Breast tissue atrophy may be a result of aging, or the pressure exerted by a usually large breast implant in relation to the patient breast and chest wall size. This adverse effect is not very common.

After the scare tactics of certain aspiring stars in the media had been worn thin by legitimate studies, it became clear that breast feeding after silicone breast augmentation was safe. From a purely physiologic standpoint two factors stand in the way of silicone secretion into milk. The first factor is the size of the silicone at the molecular level, the second is the fact that silicone never comes into direct contact with the cells that line the duct that secretes the milk. One of the surgical approaches to breast augmentation surgery, the circumareolar (around nipple) cuts through the breast ducts. Three approaches, the inframammary (under breast in fold), transaxillary (armpit), and TUBA (through the belly button). Even when the surgical approach carries a risk of transecting, or cutting through the milk carrying ducts, the passages either heal, or become blocked as in fibrocystic change, but do not retain a communication with the implant cavity making this of no consequence. As much as it would make for a good sensationalistic "story," silicone breast implants do not harm the baby.

Breast augmentation surgery should not affect breast feeding. Because breasts gain more projection and substance after enlargement, they are typically easier to hold. Because they protrude more, and are easier to hold, breast feeding becomes much easier. Paradoxically breast feeding is actually less difficult for some women, after breast augmentation surgery. Given all of this, however, there are studies showing that women with breast implants report an inability to feed in up to 2/3’s of the implanted population, compared to 7 in 100 for women without breast implants. It is doubtful, however, that matching for size and age such results would ever hold up.

Besides cancer, calcium accumulates in areas of trauma or inflammation such as surgical sites. Although calcium present in and/or around tumors has a distinct configuration, it may be mistaken for a possible malignancy with a resultant recommendation for biopsy and/or extirpative surgery. Such procedures may result in the need for implant removal and replacement, or even breast reconstruction. A baseline mammogram prior to breast augmentation , and radiologic centers experienced in the Eklund technique would likely diminish the chances for this.

According to multiple studies, there is no association between breast enlargement surgery and breast cancer.

The ideal candidate is over 18 years of age, that is a consenting adult, psychologically fit, healthy, has well-defined and realistic expectations of the breast enlargement process, and is not under the impression that breast augmentation surgery is the answer to all of her life’s problems. Patients who are inappropriate candidates include women with a breast malignancy, or pre-cancerous tumor(s), are pregnant or nursing or breast feeding post-partum, the presence of acute or chronic infection, including oral or dental. Relative red flags include psychological or emotional instability, stressful life-events, and unrealistic goals and expectations.

The ideal candidate is over 18 years of age, that is a consenting adult, psychologically fit, healthy, has well-defined and realistic expectations of the breast enlargement process, and is not under the impression that breast augmentation surgery is the answer to all of her life’s problems. Patients who are inappropriate candidates include women with a breast malignancy, or pre-cancerous tumor(s), are pregnant or nursing or breast feeding post-partum, the presence of acute or chronic infection, including oral or dental. Relative red flags include psychological or emotional instability, stressful life-events, and unrealistic goals and expectations.

A breast implant capsule is the firm, sometimes hard and thick, scar tissue that forms on the inside of the breasts and surrounds the breast implants after breast enlargement surgery. This sphere can contract over time, and squeeze the breast implants (capsular contracture). This would certainly place the breast implants in one position with almost no mobility. The positions of the left and right implants may be distorted with respect to each other, and also in relation to the chest wall. The shape of the breasts may also be made abnormal in any direction. The breasts may also feel unnaturally hard. Finally, significant pain may also be present. The incidence of this capsular contracture is thought by many plastic surgeons to be related to blood collection, fluid collection, contamination, or infection at the time of breast enlargement surgery. It is also more common when the breast implants are placed on top rather than behind the pectoralis muscle. Surgical options for the treatment of capsular contracture include releasing the capsule circumferentially, completely excising the capsule, or even the former or latter combined with breast implant replacement. Regardless of the intervention, there is no guarantee against the recurrence of capsular contracture.

Chest wall deformity may be a result of aging, or the pressure exerted by a usually large breast implant in relation to the patient breast and chest wall size. This adverse effect is not very common.More common is a congenital anomaly whereby the deficit is present before augmentation as in pectus excavatum or carinatum (and inward or outward bowed chest).

Acute pain is common, chronic pain is not. Both U.S. implant manufacturers have similar data to this effect. Although "improper size, placement" are stated by some to be the culprits, the allegation is laughable, because the proper size and placement is dependent entirely upon patient anatomy and preferences. Transection of nerves supplying skin may lead to prolonged pain as the nerves heal over months. Most surgeons will attempt to stretch the tissue around the area where the nerve travels hoping to avoid this. Capsular contracture may cause traction on cutaneous nerves, lading to pain. Relentless, intense breast pain should prompt an urgent notification of the operating plastic surgeon.

The inside scar that forms around a breast implant, whether silicone or saline, can compress that implant and make it look and feel very unnatural. Years ago a method devised to "break" apart this capsule was quite commonly used. Although successful in some instances, many times the technique led to implant rupture, necessitating removal of the breast implants, and re-implantation.

This question can be answered by comparing Rembrandt painting with his old brush, and a painter-for-hobby using the latest and greatest in paintbrush technology. It is not so much the brush, as the brusher. I’ll take Rembrandt any day. That being said, the so called "gummy bear" silicone breast implants have many advantages, and a few disadvantages. They are likely the ideal implant for breast reconstruction patients, patients with thin skin or no native breast tissue who desire large breasts, and patients to whom incision size is not of the outmost importance.

Any board certified plastic surgeon who has agreed to abide by the patient selection criteria, to provide follow-up data, and to enroll in the ongoing studies may use this implant.

Presently, and as with other types of silicone breast implants, the cohesive gel ("gummy bear") silicone breast implants can only be examined for a possible leak by Magnetic Resonance Imaging (MRI). Because silicone tends to remain inside the capsule that is formed around each implant, it would be very difficult to pick this up on routine x-rays or mammograms.

After the implantation of thousands of such breast implants in Europe, the reported incidence of rupture is confined to several cases. This may be because most cases of rupture may not be picked up owing to the "gummy bear" consistency of the silicone gel. The consequences of leaking "gummy bear breast implants" are not well known, and there are studies going on right now to determine the safety of this cohesive silicone gel implant. Intuitively, the silicone "gummy bear" implant should not migrate as much as would be expected of the more liquid older generation silicone breast implants.

Regardless of the degree of silicone cohesiveness in an anatomically shaped breast implant, it will always have a thinner end and a thicker end. It is very important that the position of the implant be maintained so that no distortion occurs, as would happen if the breast implant flipped up, or front to back. Textured implants tend to adhere firmly to their breast capsule, preventing any rotation, and malposition.

Hemorrhage (bleeding), infection (superficial skin and soft tissue, or deep around the soft tissue surrounding the implant), implant exposure (implant poking through the incision), incision dehiscence (wound coming open), loss of nipple sensation (complete or partial), loss of sensation in breast skin (usually lower part), palpable or visible defects such as rippling or capsular contracture, breast implant rupture, silicone leak with the possibility of a local inflammatory reaction, capsular contracture (inside scar that may squeeze the implant into an unnatural form), seroma (fluid accumulation as your body attempts to fill a potential space).

Pseudoscientific "studies" reported on cases of connective tissue disease supposedly associated with breast implant use in breast augmentation surgery. No study to date has ever demonstrated this. Many women who went on to develop connective tissue disease after breast augmentation attributed the problem to the implants, but the truth is that the incidence of such patients within the breast enlargement population and the general population is the same.

In addition to all of the possible complications, and unplanned additional surgeries you should also consider the possibility of health insurance premium increases. It may also be a good idea to invest in CosmetAssure®. This is an independent insurance company that offers coverage for patient treatment in cases of post-surgical complications related to cosmetic surgery for a one-time premium.

Prices range from as little as $2,500 to as high as $15,000. There are several factors that go into the price of breast enlargement surgery.

1. Geographical area is probably the most likely factor to affect the price of breast enlargement surgery. Prices tend to run lower in regions where the population is less affluent on average, where cosmetic surgery is considered less necessary, but also where competition is more prevalent.
2. Surgeon availability is another important factor in price setting. A surgeon whose schedule is entirely booked for months on end, will generally "skim the top," in terms of patients who can afford higher prices. This does not mean there is no one out there who can do as good a job. It means that a particular surgeon knows he or she can get a certain amount of money for his or her breast augmentations.
3. Another important part of the ultimate cost that is passed on to the patient is whether or not the plastic surgeon owns the facility at which the breast enlargement surgery is carried out. Although part of the facility fee may then go to the owning surgeon, it may be set substantially lower than a facility fee that would be paid to a third party such as a hospital or operating center when carrying out the breast enlargement surgery.
4. A factor related to the facility fee is whether or not the surgeon prefers to use general anesthesia, or to employ the services of an anesthesiologist, or whether the plastic surgeon favors surgeon administered sedation with regional blocks for carrying out breast enlargement surgery. Obviously, the addition of an anesthesiologist or even a certified nurse anesthetist will add cost to breast augmentation. It is important to realize, however, that paying for an anesthesiologist does add a certain measure of safety, regardless of what anyone may tell you to the contrary.

Delayed wound healing is not very common after breast enlargement surgery. Because the incisions are relatively small, and with proper technique the breast tissue is not devascularized the problem is rarely seen in healthy patients. Nicotine use, poorly controlled diabetes, chemotherapy, radiation therapy, vascular disease, immunosuppressive therapy or disease, use of corticosteroids may all lead to delayed wound healing.

Both Allergan and Mentor publish data with respect to adverse outcomes after breast enlargement surgery with either silicone or saline breast implants. Disappointment with cosmetic outcomes of breast enlargement surgery with either silicone or saline breast implants are a result of miscommunication in preference or obvious defects. The former comes from the plastic surgeon and his or her patient not being on the same page with respect to shape, size, or incision placement. The latter is either an unavoidable fact of breast augmentation or a technical problem. Breast implant rippling and wrinkling, possible asymmetry with implant migration, scar migration, or audible sounds with manipulation that present months after the procedure are usually not the result of surgical misadventure. Asymmetry in shape, size, or incision placement immediately after the surgery can be attributed miscalculation. Hypertrophic scarring, implant visibility, implant palpability, and hardening of the breast capsule with resultant distortion in shape are typically not a result of surgical error.

The "dual-plane" approach allows placement of the upper portion of the implant under the muscle, and by releasing the lower portion of the muscle allows the lower portion of the breast implant to sit under the breast tissue. This eliminates the drawbacks of both the sub-glandular and sub-muscular placement while retaining the advantages of both. It is the most commonly performed placement in today’s breast augmentation surgery.

There is a gentle curve to the breast. The top portion protrudes less, the bottom more, creating a gentle slope. The argument for a shaped gummy bear breast implants makes sense intuitively only. That is, a formed breast implant will maintain its shape at the top and not sag to the bottom, as would a more liquid implant. This is cannot be true, not because I disagree with it but because liquids are non-compressible, as are solids. A more liquid-like implant may be more prone to deformation through gravity, but all that would cause is rippling, as the down pulling silicone would exert traction on the top portion of the implant.

Although probably less likely than other type of breast implant rupture, the "gummy bear silicone breast implant" can rupture or tear. After the implantation of thousands of such breast implants in Europe, the reported incidence of rupture is confined to several cases. This may be because most cases of rupture may not be picked up owing to the "gummy bear" consistency of the silicone gel. The consequences of leaking "gummy bear breast implants" are not well known, and there are studies going on right now to determine the safety of this cohesive silicone gel implant. Intuitively, the silicone "gummy bear" implant should not migrate as much as would be expected of the more liquid older generation silicone breast implants.

Cohesive gel breast implants were formulated with a thicker form of silicone (viscous silicone polymer as a result of more extensive cross-linking) resulting in three ideal properties; less silicone "run-off," in the case of rupture, no rippling, and maintenance of more precies form. If you slice into a third generation cohesive gel implant from Mentor and turn the two halves over, the silicone will not leak, drip, or run. You can see how this would be advantageous in case of rupture. It should be mentioned that "cohesiveness" is an attribute that is present in most of the older generation implants, so technically using such implants may be described as using cohesive gel implants. Recently, the latest generation of silicone breast implants was dubbed cohesive in the media. This is true, but misleading, once again, because all silicone implants are cohesive to a certain extent. What most consumers are interested in when they refer to cohesive implants are the so called "gummy bear implants," or the latest generation of highly cross-linked silicone breast implants. So, back to the two most favorable properties of the so called "gummy bear breast implants." They are more solid, and they do not ripple. This makes them ideal for thin skinned patients, because soft tissue cover (breast tissue or fat) is not as important in concealing the implant since the formed or cohesive gummy bear breast implant should hold its shape, and not ripple. It is also ideal in breast reconstruction for the same reason, and because large incisions are already present from the mastectomy (breast removal).

FDA regulations mandate that all new devices be subjected to rigorous clinical trials to determine their safety regardless of how safe they may be thought, or how many regulatory bodies have approved them outside of the United States.

Unfortunately, this is a question that can be answered only in speculation, without hard medical evidence. Presumably the more solid, formed nature of silicone "gummy bear" implant would not allow as much leakage, or as rapid a spill as a conventional silicone implant. This means that a patient would not be able to pick this up on routine self-inspection very easily. Having stated this a "gummy bear" implant patient who develops soreness and possibly enlarged lymph nodes in the armpit should promptly report to her surgeon.

The breast enlargement surgery itself should be painless, whether performed under sedation with local anesthetic, or general anesthesia. It is the postoperative period that some may find brings discomfort. Assuming the postoperative course is without complication, pain from breast augmentation surgery peaks the day after surgery, and diminishes over the course of the following three to four days to be tolerable enough without the use of narcotics. Of course, pain tolerance varies significantly from patient to patient. The 72-96 hrs time frame is a "ballpark" figure, and a reflection of personal experience. Several other important factors are crucial to consider in breast enlargement surgery. Pre-incisional administration of local or dilute local (called tumescent) anesthetic greatly diminishes postoperative breast enlargement surgery pain. Postoperative pain and tenderness can be further affected by breast implant placement position. Sub-muscular placement or "dual plane" placement may cause substantially more discomfort than sub-glandular placement because of muscle dissection. If a skin excision is necessary, pain may be more pronounced. The injection of local anesthetic at the conclusion of breast augmentation surgery greatly diminishes postoperative discomfort. In addition, a more effective multiple intercostal nerve block may be performed. Finally, a small catheter may be placed, within the breast implant pocket, for the purpose of delivering local anesthetic in the post breast enlargement surgery period. This has been shown in studies to help significantly with postoperative discomfort. In short, breast enlargement surgery is very well tolerated in most patients.

This type of breast implant is not available in the U.S., and has been taken off the UK market. This is not because it is unsafe, but because not enough data exists to prove that it is safe. The same substance that is used to manufacture Juvaderm®, Restylane®, Captique®, Hylaform®, etc., was used to manufacture the Hydrogel-filled implant. That is, it was used as the filler in the standard silicone elastomer shell. Since the implants are not available, further discussion is unwarranted. For further information, please read the information put forth by the British MHRA (Equivalent of FAD, except for the food part).

"Hydrogel filled breast implants are no longer available in the UK.

Hydrogel breast implants consisted of a silicone elastomer shell containing hydrogel filler. Hydrogels are polymeric materials that have the ability to swell in water without dissolving and retain water within their structures.

Until December 2000, there were two models of hydrogel filled breast implants on the UK market. Because of continuing concern over the safety of breast implants, the MDA (Medical Devices Agency, a forerunner to the MHRA) carried out a series of investigations into the safety of the various filler materials used in the implants available in the UK. The MDA's investigations into hydrogel-filled breast implants revealed inadequacies in the manufacturers' biological safety assessments and concluded that there was not enough information to fully assess the safety of either of the hydrogel filler materials. When they were made aware of the results of the MDA's reviews, both manufacturers decided to withdraw their hydrogel-filled breast implants from the UK market in December 2000 as a precautionary measure, pending further studies to establish the safety of the filler materials.

It must be emphasised that no definite risk has been identified. The concern lay only with the way the safety of the hydrogel fillers had been assessed. The MHRA is continuing to monitor the safety of these implants and, based on the currently available evidence, does not recommend that women with hydrogel-filled breast implants have them removed unless they are experiencing problems.

Women who think that they may have hydrogel breast implants and are concerned, should contact the surgeon who carried out their operation, their GP or get advice from NHS Direct on 0845 4647 or in Scotland the Scottish NHS Helpline on 0800 224488.

Clinicians and members of the public should continue to report adverse incidents to the MHRA.

Information specific to each hydrogel filled breast implant:

1. PIP Hydrogel breast implants were made in France and supplied in the UK by Clover Leaf Products Ltd. Approximately 4000 women in the UK received these implants since they were first introduced in 1994. The removal of these implants from the UK market was the subject of Device Alert DA 2000(07). This noted concerns about uncertainty over the metabolic fate of the filler material and about pathological changes seen in rats following implantation of the filler material that suggested the possibility of a systematic effect. The CE-marking was removed in 2002.
   
   In May 2005 the Committee on Toxicity (COT)1 reviewed two animal studies commissioned by PIP. Although some effects were seen in the kidneys of the tested animals, in a statement (external link) prepared in January 2006, the Committee concluded that these results suggested that exposure to the hydrogel filler will not lead to toxic effects in women with these implants. There is therefore no indication for a proactive explantation programme. The Committee did, however, express concern about the lack of long-term follow up of women with breast implants.
   
   The MHRA has received adverse incident reports of breast swelling associated with the presence of fluid in the implant pocket around PIP Hydrogel breast implants. The MHRA continues to monitor the safety of PIP Hydrogel implants and, based on the currently available evidence, does not recommend that women with these hydrogel-filled breast implants should have them removed unless they are experiencing problems. However clinicians who remove implants due to swelling (with or without suspected implant rupture) should consider having the implants weighed and photographed, carrying out histology of the surrounding capsule and cytology of any collected fluid; such cases should be reported to the MHRA.



2. NovaGold™ breast implants were made in Germany and supplied in the UK by Somatech Medical Ltd. Approximately 250 women in the UK received these implants since they were first introduced in 1996. It is estimated that around 80% of these implants were implanted by the private sector for cosmetic reasons. The removal of these implants from the UK market was the subject of Device Alert DA 2000(08). It is unlikely that any further information to verify the safety of the filling material of Novagold™ breast implants will become available. While uncertainty remains over the long-term safety of this product, the MHRA has received no reports of adverse effects that give rise to concern over their clinical safety and has no reason to recommend removal of Novagold™ breast implants."

Cohesive Gel Breast Implants (Gummy Bear Breast Implants), Hydrogel Breast Implants (Hyaluronic-Acid Filled Breast Implants), PIP Hydrogel Breast Implants, PIP Saline Breast Implants, Trilucent Breast Implants (Peanut Oil Breast Implants, Soy Oil Breast Implants, Soya Oil Breast Implants, Soybean Oil Breast Implants), Hydrophilic Polyacrylamide Gel Breast Implants.

The exact risk percentage may be found for both the Allergan, and the Mentor studies in related questions. The problem most often is the result of inadequate soft tissue (breast and skin) overlying the breast implants. It is unusual in cases of primary augmentation, and is more commonly seen in the compromised soft tissue of the reconstructed breast.

If the extrusion if only threatened, and no implant is actually showing at the time of detection, a salvage procedure may be done to improve the soft tissue cover atop the implant. If the implant is exposed, many plastic surgeons will not attempt salvage, as by definition, and exposed implant is a contaminated implant. The breast implant will be removed, patient allowed to heal, and implant replaced at a later time.

A breast implant is more likely to be noted on manipulation of the breast when they are too big for the breast and soft tissue present, when they are over, rather than under the muscle, and when they are textured. Ensuring a small enough base width, good soft tissue cover with a submuscular or dual-plane placement, and using smooth breast implants will decrease the risk for this.

Breast implants have fold flaws. Because of the consistency of silicone gel, and predetermined, and optimal filling, the flaws may be less pronounced in such breast implants. Saline breast implants may produce scalloping and folding that is made more pronounced by overfilling, or under-filling breast implants. The visibility or palpability of breast implant rippling is accentuated by lack of breast tissue, fat tissue, or muscle tissue between the breast implants, and their overlying skin. The solutions to the problem include replacement with the latest generation cohesive gel implants or augmentation of the soft tissue covering the breast implants with flaps.

Problems not specific to silicone breast implant rupture include breast hardness, a change in breast shape or size, and breast pain. Gel migration has also been infrequently reported to areas far removed from the breast like the underarm, abdominal wall, arm, groin, and chest wall. Inflammation around nerves, granuloma and scar formation have been associated with this. Silicone migration has also been rarely reported to lymph nodes, in absence of rupture.

Breast enlargement implants collapse when either saline or silicone that is contained within them leaks out through a broken valve (saline breast implants only), or a tear in the implant shell (both silicone and saline implants). Saline is reabsorbed rapidly, and a dramatic change in size will be noted by the patient within days. Silicone breast implants rupture may go undetected, may present with a slight change in shape from one breast to the other, or may have a more pronounced difference in size between the two breasts. Many rupture events go unexplained, but may be due to inherent defects in the implant with worsening over time. Known reasons for deflation consist of overfilling or underfilling saline breast implants, obvious causes such as undetected damage to the breast implants in surgery (tears, needle holes, etc.), trauma whether via accident, aggressive manipulation during intimate contact, or during mammography, the scar around the breast implant squeezing to the point of rupture (capsular contracture), attempted rupture of such contracture via closed capsulotomy. Consequences of saline rupture are cosmetic only. Many ill-effects have been attributed to silicone leak, however, in spite of opportunistic attempts at destroying scientific method of research as it applies to silicone breast implants, local inflammation and difficulty in extracting all of the leaked silicone gel has been the only real issue. Obviously, the treatment in such cases is implant removal and replacement.

There are multiple different types of implants available for use in breast enlargement. In addition multiple permutations of the various prosthesis types yield a fairly wide array of choices in terms of material, shape, coating, size. In addition, each of the two currently approved breast prosthesis manufacturers in the United States (Inamed™ and Mentor™) makes their own version of each implant with the varying characteristics. The availabilities are as follows. Each implant is encased in a silicone elastomer shell. The shell may be smooth, or textured. The shell may be shaped like a tear-drop, also referred to as anatomical, or the shell may be perfectly round. Each configuration of the round implant may have a different degree of projection even if the amount of volume contained within is the same. As an example, one style of implant may have a volume of 500cc and a projection of 3.6cm, while another, may have a volume of 500cc but a projection of 4.7cm as a result of a narrower base. The filling material of a breast implant may be silicone, or saline, or both in the case of some implants used for breast reconstruction. The size of an implant may vary to over 1000cc, though volumes of that size are not currently approved in the U.S. and must be procured through companies in Europe or South America.

There are two FDA approved manufacturers of breast implants within the United States, Mentor™ and Allergan™. Each corporation has its own breast prosthesis warranty, with options for more extensive coverage. Both policies are quoted below.

"Mentor’s free Lifetime Product Replacement Policy involves the free lifetime product replacement for its gel-filled and saline-filled breast implants, worldwide. When implant replacement is required and the Mentor Product Replacement Policy applies (see below), Mentor will provide, throughout a patient’s lifetime, the same or similar Mentor breast implant at no cost. If a more expensive product is requested, Mentor will invoice the surgeon for the price difference.

The Mentor Standard Advantage Limited Warranty is free of charge to all patients who are implanted with Mentor gel-filled or saline-filled breast implants in the United States and Puerto Rico. When the limited warranty applies, Mentor provides the following:

• Financial assistance: For the first ten years following a breast implant procedure, Mentor will provide financial assistance up to $1200 to help cover operating room, anesthesia, and surgical charges not covered by insurance. Financial assistance applies to covered events only (see below). Operating room and anesthesia charges will be given payment priority. In order to qualify for financial assistance, the patient will need to sign a Release Form.
• Free contralateral (opposite side) implant replacement upon surgeon request.
• Non-cancelable terms.

The Mentor Enhanced Advantage Limited Warranty is an optional limited warranty available for women who are implanted with Mentor gel-filled or saline-filled breast implants in the United States and Puerto Rico. To be eligible, the Mentor Enhanced Advantage Limited Warranty must be purchased for an enrollment fee of $100 within 45 days from implantation. When the warranty applies, Mentor provides the following:

• Financial assistance: For the first ten years following a breast implant procedure, Mentor will provide financial assistance up to $2400 to help cover operating room, anesthesia, and surgical charges not covered by insurance. Financial assistance applies to covered events only (see below). Operating room and anesthesia charges will be given payment priority. In order to qualify for financial assistance, the patient will need to sign a Release Form.
  
  
• Free contralateral implant replacement upon surgeon request.
• Non-cancelable terms.

With both the Mentor Standard Advantage and Mentor Enhanced Advantage Limited Warranties, it is important for the patient to also maintain her own records to ensure validation of her enrollment.

Products Covered
The Mentor Standard Advantage Limited Warranty coverage applies to all Mentor gel-illed and saline-filled breast implants that are implanted in the United States and Puerto Rico, provided they have been:

• Implanted in accordance with the Mentor package insert, current to the date of implantation, and other notifications or instructions published by Mentor; and
• Used by appropriately qualified, licensed surgeons, in accordance with accepted surgical procedures.

Events Covered
The Mentor Lifetime Product Replacement Policy, and the Standard Mentor Advantage and Enhanced Advantage Limited Warranties coverages apply to the following:

• Rupture due to localized stress, folding, manufacturing defect, patient trauma, or unknown cause
• Other loss-of-shell integrity events, such as surgical damage may also be covered by these programs. Mentor reserves the right to determine if specific, additional events should be covered.

Events Not Covered
The Mentor Lifetime Product Replacement Policy and the Mentor Standard Advantage and Enhanced Advantage Limited Warranties coverages do not apply to the following:

• Removal of intact implants due to capsular contracture, or wrinkling.
• Loss of implant shell integrity resulting from reoperative procedures, open capsulotomy, or closed compression capsulotomy procedures.
• Removal of intact implants for size alteration.

Filing for Financial Assistance

• To file a Mentor Advantage claim for product replacement and/or financial assistance, the surgeon must contact the Mentor Product Evaluation Department at 1-866-250-5115 prompt #1 prior to replacement surgery.
• For financial assistance claims, a patient-specific Release form will be generated that the patient must sign and return.
• For either replacement or financial assistance claims, the surgeon must send the explanted, decontaminated Mentor breast implant(s) within six months of the date of explantation to:
  Mentor Product Evaluation
  
  3041 Skyway Circle North
  Irving, Texas 75038-3540
  
  
• Upon receipt, review and approval of the completed claim, including receipt of the explanted product and the patient’s completion of a full general release, financial assistance will be issued.

This is a summary of the coverage of the Mentor Advantage and Enhanced Advantage Limited Warranties. It is an overview only and not a complete statement of the program.

A copy of the complete Mentor Advantage and Enhanced Advantage Limited Warranties for saline-filled and silicone gel-filled breast implants may be obtained by writing or calling:

Consumer Affairs Department
Mentor Corporation
201 Mentor Drive
Santa Barbara, CA 93111
1-800-525-0245

A copy of the complete programs may also be obtained from the surgeon or by going to www.mentorcorp.com.

THESE ARE LIMITED WARRANTIES ONLY AND ARE SUBJECT TO THE TERMS AND CONDITIONS SET FORTH AND EXPLAINED IN THE APPLICABLE MENTOR LIMITED WARRANTIES. ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS ARE EXCLUDED.

Mentor reserves the right to cancel, change, or modify the terms of the Mentor Advantage and Enhanced Advantage coverages. Any such cancellation, change, or modification will not affect the currently stated terms of the Mentor Advantage and Enhanced Advantage coverages for those already enrolled.

Allergan
Optional ConfidencePlus™ Premier Warranty
Allergan ConfidencePlus™ breast implant limited warranty programs offer you coverage in the event of implant rupture, including product replacement and financial assistance to cover expenses not reimbursed by your insurance carrier. Our standard ConfidencePlus™ applies automatically to every Allergan breast implant recipient and includes lifetime product replacement and up to $1200 in financial assistance subject to the conditions discussed in the ConfidencePlus™ literature. The optional ConfidencePlus™ Premier breast implant limited warranty provides all the peace of mind included with our standard ConfidencePlus™ program, but increases the financial assistance to $2400 and offers free contralateral implant replacement. For the low enrollment fee of $100 you have access to lifetime product replacement, 10 years of coverage, the freedom to change styles or size as part of your replacement surgery, free contralateral implant replacement and up to $2400 in financial assistance. That’s peace of mind… That’s ConfidencePlus™ Premier! To enroll in our optional ConfidencePlus™ Premier breast implant limited warranty program use the information contained on your Allergan Device Identification Card(s) supplied to you after surgery or complete the purchase form that follows this page. Once complete, detach the form from this breast surgery planner and return to Allergan in the envelope provided. You may also fax your completed enrollment form with credit card information to 805.967.5839. Your purchase form and $100 must be received or postmarked within 45 days of surgery and must accompany a certified check, money order, or valid credit card number in order to process your purchase. Do not send a personal check. ConfidencePlus™ Premier enrollment forms that accompany a personal check will not be processed."

The filling of saline breast implants with anything other than saline, bathing saline breast implants in iodine solution, penetration of the saline breast implant shell during injection, utilizing more than one saline breast implant per side, attempts at reshaping the saline breast implant can all compromise the integrity of the saline breast implants’ shells and lead to rupture or leak.

Dr. Gerzenshtein’s recommendations to his patients are found below. Consult with your own surgeon for his ore her specific instructions. After surgery you will be placed in a bra, possibly with an ace wrap above it. If the ace is present, it was applied to control pocket position in cases where implant position was made submuscular and the muscle was not entirely divided at its lower edge, this means that the ace wrap must be re-applied exactly the way you were instructed. The ace wrap along with the dressing, will removed for the first time 24 hours after surgery, in the office. After the initial dressing change, dressings should be changed twice a day in the following manner: Remove old dressing and wash or shower, after drying, apply new dressing; ABDs followed by bra, then ace if indicated. When the edges of the steri-strips become frayed trim them. With time, as very little is left behind, they may be removed (usually 2-4 weeks). It is not routine to have drains placed at the time of surgery, however, at times, if bleeding is diffuse, and cannot be addressed via surgical maneuvers (clipping, suturing, tying) it may be safer to leave behind a drain in attempting to prevent a hematoma (blood collection), if present, the drains will be removed within one to three days. Wear a soft comfortable bra for the first 7 days after surgery. Two weeks after surgery you may purchase any type of bra you wish. If non-absorbable sutures were used, they will be removed 7 days after surgery. You may begin breast massage the 2nd week after surgery, you will be instructed on breast massage at your post-op appointment, continue massaging for at least 6 weeks after surgery. Do not expose incisions to the sun and/or tanning UV light for at least 1 year, however, you may begin tanning 4 weeks after surgery while keeping incisions covered. If sun exposure in unavoidable, use a product with SPF of at least 30.

The filling of saline breast implants with anything other than saline, bathing saline breast implants in iodine solution, penetration of the saline breast implant shell during injection, utilizing more than one saline breast implant per side, attempts at reshaping the saline breast implant can all compromise the integrity of the saline breast implants’ shells and lead to rupture or leak.

The inframammary approach to breast augmentation surgery allows your plastic surgeon the greatest visibility while dissecting an implant pocket, and as such, allows greater precision and control of symmetry. The inframammary incision is placed in the fold under the breast, in the breast fold, and tends to be more noticeable for two reasons. It is typically larger than other types of breast incisions. It has a tendency to migrate as the implant settles up or down, and its final resting place is less predictable.

The periareolar incision goes around the nipple. It is less noticeable, smaller than the inframammary incision, and if a lift is required later in time, it may be utilized again. Its disadvantages in breast enlargement surgery are a higher infection rate (because the cut goes through breast tissue), possible difficulty in breastfeeding, and the risk of decreased sensation in breast skin and nipple sensation.

Placing the incision in the axilla (underarm) allows for a smaller incision. It is useful when there is not much breast tissue present to begin with, and thus no prominent breast fold, and when the nipple-areola complex is small. It is not as well concealed as the periareolar incision, gives less control in terms of the ability to feel around the breast pockets in assuring symmetry, and placement of silicone breast implants will necessitate a larger incision which may be less pleasing.

The peri-umbilical incision is placed at the top of the belly-button. Its obvious advantage is a lack of scars on, around, or near the breasts. Its disadvantages are blind dissection, making asymmetry more common, and making the likelihood of one side being submuscular and the other subglandular more likely. If an undesirable result is obtained, a new incision will be needed to correct the problem. It may also damage the breast implants, and cannot be used with pre-filled silicone breast implants.

Any surgery, in any discipline carries a risk of infection. The risk is calculated based on the degree of contamination for a particular operation. Breast augmentation is considered a "clean" surgery, and carries an overall infection rate of less than two percent. If infection should take place, it will most often affect one or more of three patterns, assuming there is no disseminated spread, and the infection remains localized. Infection can occur in the skin, in the soft tissue surrounding the implant, and in the form of a pus pocket. Skin infection will usually respond to oral antibiotics. Soft tissue infections surrounding the breast implant may respond to oral antibiotics, will sometimes require intravenous antibiotics, and in other cases need to be treated with implant removal. If the infection should progress to, or start out as an abscess (pus-pocket), the only treatment that will be effective in treating the infection and preventing more serious systemic complications is drainage of pus and breast implant removal. Toxic Shock Syndrome (TSS) may result from the presence of a foreign body (breast implant in this case) in the setting of an infection, and is a truly life-threatening condition that needs to be addressed immediately. It is marked by high fever, nausea and vomiting, diarrhea, light-headedness and possibly loss of consciousness, and a diffuse rash. The treatment is timely institution of IV antibiotics, and breast implant removal. If the breast implant is removed, the infection should be treated, the inflammation allowed to resolve, and a new implant placed weeks down the road.

The inframammary approach to breast augmentation surgery allows your plastic surgeon the greatest visibility while dissecting an implant pocket, and as such, allows greater precision and control of symmetry. The inframammary incision is placed in the fold under the breast, in the breast fold, and tends to be more noticeable for two reasons. It is typically larger than other types of breast incisions. It has a tendency to migrate as the implant settles up or down, and its final resting place is less predictable.

The controversy over the safety of silicone breast implants was founded more on the desire to wage successful litigation with lucrative awards, than on science. It was raised more to shift public opinion in the direction of paranoia and "uncover" some sinister plot while building a "solid" career in journalism, than to extricate fact from events. The battle was a classic of example of lies repeated long enough, loud enough, and by enough visible and "educated" people to sway the opinion of juries from fact to confabulation. One thing for certain, science, fact, or truth had nothing to do with the conduct of the players. Money, greed, and ambition had everything to do with it.

Let’s begin by noting first that nothing in life is guaranteed. In allowing oneself to be implanted with breast prosthesis, a patient is permitting an unnatural act upon herself. A foreign substance is placed into a consenting body. Any foreign substance, or object will be regarded by the organism as just that, a foreign body. Any such foreign substance will incite a response, be it a breast capsule, or a more violent immune response. The question should then be restated, "how unsafe is a silicone implant?" The parties involved in condemning the use of silicone without a shred of scientific evidence effectively cheated millions of women afflicted with breast cancer out a perfectly good breast reconstruction, unless they were willing to enroll in a study. To add to the charade, millions more who had been implanted, but symptom free, had their breast implants removed. To answer the question of breast implant safety, we need to look back to the beginning…

In the 1940’s, convinced of the American GI’s penchant for large breasts, Japanese prostitutes would inject their mammary glands with various materials of dubious origin. The substances included sponge, paraffin, and silicone. Fast forward to the 1960’s. Doctors Gerow and Cronin began implanting silicone breast prostheses in Houston. In 1976, the silicone breast implant, along with all other medical devices came under the jurisdiction of the Food and Drug Administration in an amendment of the Federal Food, Drug, and Cosmetic Act. Because silicone implants were in use for years prior to the enactment of the amendment, the only requirement imposed on their producers was the provision of safety data on FDA’s demand. In 1977, the first settlement from Dow was furnished to a patient with "pain and suffering" as a result of implant rupture requiring multiple revisions. In the 1980’s, Ralph Nader’s Public Citizen Health Research Group began implicating silicone breast implants in the etiology of breast cancer. As is the case with many of Mr. Nader’s allegations today, the statements were based on anecdotal "evidence." This is the type of proof the scientific community regards as equivalent to no proof, and the type our attorney friends call hearsay. As a result of the dissemination of this propaganda, in 1982, the Food and Drug Administration suggested that silicone breast implant producers demonstrate conclusively the safety of silicone breast implantation, placing the device into category III. In 1984, Maria Stern was awarded 211k in compensatory, and 1.5m in "punitive" "damages." The charade put on by Dan Bolton, her "attorney," included the testimony of theorizing "experts," who through their "expertise," but without the burden of true scientific research or proof of any kind, linked breast cancer with silicone. The 1982 category III re-classification proposal materialized in 1988, with the premarket approval applications (PMA) due date set in July of 1991. The FDA would then review the applicants’ data over the following six months. Prior to any such due process, however, the case for the silicone implant was "reviewed", no doubt after exhaustive "research," by Connie Chung on "Face to Face." Sensationalism sells, and Connie’s brand sold particularly well. Without regard for truth, and based entirely on a handful of anecdotal reports and cases, she effectively paraded women who claimed to contract autoimmune disease from breast implants, in the process fueling the baseless paranoia. It is quite unfortunate, and very sad that these patients were sick. It is even more unfortunate that a third party was able to use them to capitalize on emotions stirred up in the public. The "good" journalist never stopped to think that of the millions of women who had silicone implants placed, some were bound to be affected by autoimmune disease at the rate of the general population. Truth, however, seldom makes careers. At around the same time Ralph Nader’s "Public Citizen" jumped on the band wagon, aided Dr. Sidney Wolfe, stoking the flames and pressing in courts, while Representative Ted Weiss headed a Congressional Hearing on the safety of silicone breast implants. It is interesting that a court order from the Stern hearing barred the presentation of certain evidence for public scrutiny. As per schedule, Dow Corning released 329 studies to the FDA in July of 1991. In the same year, Toole vs Baxter, a jury in Alabama lynched Baxter with the largest award to date (over $5 mil.). The plaintiff, it was argued, was afflicted with the early stages of autoimmune problems. She had evidence of silicone in her "system," according to the plaintiff’s "expert" witness. Towards the end of the year, in September the Food and Drug Administration concluded that the safety data received from implant manufacturers did not demonstrate either way, for, or against silicone implant safety. The producers of the devices were asked to submit additional data. In November of the same year the reviewing panel, composed of physician representatives from most medical fields, along with both industry, and consumer organizations rejected data from the McGhan, Mentor, Bioplasty, and Dow Corning. Limited access to the devices, along with collection of further implant safety data was recommended to the FDA. In the meantime, the largest judgement was bumped to over $7 million, awarded to Mariann Hopkins for connective tissue disorder purported to result from leaking silicone. The plaintiff’s attorney furnished to the FDA new internal documents from Dow, as well as papers from the Stern case. A voluntary moratorium on the distribution or implantation of silicone breast implants was agreed upon by silicone breast implant manufacturers, until such time that the FDA and its advisory panel have had an opportunity to mull over the more recently available information. In February of the following year, with the apparent noble intention of compensating women more rapidly than would be possible by filing separately, Stan Chelsey filed a class action lawsuit against Dow. Of course the prospect of multiple clients, colossal returns on their cases, and the possibility of the cash cow fleeing as new evidence mounted, had nothing to do with the class action litigation. The FDA device panel reviewed further data that same month, and concluded at the time that no link has been established between autoimmune disease and silicone breast implants. The consortium recommended limiting the use of such implants to breast reconstruction only, while enrolling all recipients in rigid protocols with the intent of carrying out epidemiologic investigation. In March of 1992, Bristol-Myers, Bioplasty, and Squibb abandoned breast silicone production. In April, in accord with the advisory panel recommendations, silicone implantation is approved only in patients undergoing breast reconstruction, and then only when enrolled in a scientific protocol. Yet another record is broken by a highly ethical attorney by the name of John O’Quinn, when Pamela Jean Johnson "suffers" $5 million dollars worth of "actual" damages from symptoms quoted to amount to "a bad flu," by the plaintiff’s own attorneys and expert witnesses. Bristol-Myers takes a $20 million loss in "punitive" damages. The absurdity escalates. Lawsuits continued to mount against Dow Corning to the tune of over 12 thousand by the end of 1993. All things getting bigger in Texas, the good doctor O’Quinn "won" another $27.9 million for three clients in a lawsuit against 3M. "Silicone induced" autoimmune "phenomenon" is blamed for their ailments. In early 1994, Dow Corning, Baxter, 3M, and Bristol-Myers finalize the largest to date settlement in the ongoing class action lawsuit. No requirements were needed to prove that the claimants’ suffering was attributable to silicone breast implantation. An epidemiologic study out of the Mayo Clinic, surely not as reputable as the "expert" testimony in the aforementioned cases, was published in June of the same year that found no increase in the risk of connective-tissue disease or other specifically examined disorders that between women implanted with silicone breast implants, and the general population. By the end of the year, just under 20 thousand suits have been filed against Dow Corning. In 1995, an organization with absolutely no vested interest in the well being of the silicone implant industry, the American College of Rheumatology, issued a statement regarding "compelling" evidence against silicone breast implants’ causation of systemic disease. Never mind the truth, show us the money, give us corporate blood. In the spring of 1995 Dow Corning, facing over 20 thousand lawsuits, over 400 thousand potential claims, filed for Chapter 11 bankruptcy. This effectively ended all pending litigation, with approximately 70 of the 400 thousand claimants eligible to be paid their "winnings" at that time. The New England Journal of Medicine, in the summer of 1995, published "The Harvard Nurses Epidemiologic Study" that found no increase in the risk of connective-tissue disease or its signs and symptoms in women with silicone implants.

In October of 1995, the parent corporation of Dow Corning lost $13.9 million to Charlotte Mahlum. Unsatisfied with the total annihilation of Dow Corning, and ever on the lookout for more free money, lawsuit mongers turn their sights to the bigger fish. At the time Dow Chemical had approximately 13 thousand lawsuits pending. With Dow Corning out of the picture, and in spite of over twenty trustworthy studies refuting a causative relationship between silicone breast implants and auto-immune disease, a new settlement to include Bristol-Myers Squibb, Baxter and 3M was devised. In April of 1996, two highly astute Federal judges out of New York appointed an impartial expert panel to mull over the facts as they stood at the time, and in so doing helped to change the direction of courts throughout the country in favor of ebbing the excessive bleeding. In September of 1996, the California Court of Appeals upheld a decision dismissing Dow Chemical and Dow Corning from 1,800 breast-implant lawsuits. In December of the same year, Oregon Federal Judge Robert E. Jones, after input from a similar panel of unbiased scientists, ruled against the presentation of the scientifically unsound notion that silicone breast implants were responsible for the plaintiffs’ ailments. The American Academy of Neurology, in the first month of 1997, added to the wealth of literature and expert opinion refuting causation, stating that "existing research shows no link between silicone breast implants and neurological disorders." Toward the end of 1997 the Journal of the National Cancer Institute analyzed heaps of medical studies related to the adverse systemic effects of silicone breast implantation, with the conclusion that silicone breast implants do not cause breast cancer. At around the same time, the first class action lawsuit involving over 18 hundred claimants in Louisiana was cut down to its original eight, owing to the dissimilarity of symptoms between them. Early in the following year, scientific studies from Scandinavia could not show a link between neurologic disease and silicone breast implantation. In July of 1998, "afflicted" "patients" "settled" for Dow Corning's proposal of $3.2 billion to "reconcile" thousands of claims from so-called injury as a result of silicone breast prostheses implantation. In spite of overwhelming evidence to the contrary the Nevada "Supreme" Court upholds a compensatory damage award of $41 million to Charlotte Mahlum. Early next year, again in direct opposition to known fact, a "court" in Washington awarded $10 million to an "attorney" "patient," in compensation for her silicone implant induced scleroderma. Perhaps they believed she ought to be compensated by someone or something, never mind whose fault it is. Meanwhile, a section of the National Academy of Sciences, itself the most esteemed, and influential science organization in the U.S., known as the Institute of Medicine was asked by Congress to arrange for the review of the facts by an independent committee. This panel reached a conclusion in June of 1999, after many public hearings, and data analysis. Silicone breast implants, the scientists decided, while may be responsible for local inflammatory changes in the adjacent implanted tissue, do not cause any auto-immune diseases.

Patients who seek breast reconstruction, revision or secondary breast augmentation, or a first time breast enlargement may enroll in the trial. A list of prohibited medical conditions for participating in the study must be satisfied, and patients must agree to a ten-year follow-up.

Nerves that supply sensation to the nipple and surrounding (areolar) skin may be cut or stretched during surgery. Most often this is not the case, and if sensation is lost, it generally due to stretching of the nerves, and will eventually recover. Permanent loss of nipple sensation, however, is always a possibility. Sometimes the nipple skin will become more sensitive to any form of stimulation, which may be due to nerve involvement, or to the stretching of the skin by the breast implant. This, too, is normally temporary. Usually, it is not the nipple that loses sensation, but the nerves to the skin of the lower part of the breast, especially on its outside edge. This is because the nerves giving sensation to that part are most frequently encountered, and manipulated in some way. As with nipple sensation, this usually returns, but not always.

Nerves that supply sensation to the nipple and surrounding (areolar) skin may be cut or stretched during surgery. Most often this is not the case, and if sensation is lost, it generally due o stretching of the nerves, and will eventually recover. Permanent loss of nipple sensation, however, is always a possibility. Sometimes the nipple skin will become more sensitive to any form of stimulation, which may be due to nerve involvement, or to the stretching of the skin by the breast implant. This, too, is normally temporary. Usually, it is not the nipple that loses sensation, but the nerves to the skin of the lower part of the breast, especially on its outside edge. This is because the nerves giving sensation to that part are most frequently encountered, and manipulated in some way. As with nipple sensation, this usually returns, but not always.

There are several advantages to the use of high profile breast implants. First, just as the name suggests, for any given fill volume, high profile breast implants will implant more projection or profile when compared to moderate or "normal" breast prosthesis, and most certainly more than low profile, or anatomically shaped breast implants. The way to picture this is that if you had a cone with a highly sitting tip versus a cone with a wide base, the narrower, taller cone would point more (think of Madonna’s show bra!) and thus give more projection to the breast. What this means is that women with a narrower, smaller chest wall can still have larger breasts. The advantage to some women, and disadvantage to others comes from a basic difference in perception as what a natural breast should look like. If a patient prefers a highly "perky," high profile, or well projecting breast, the high profile breast implant would be considered ideal. High profile breast implants would not be ideal to place in a patient who prefers natural, gently sloping, and slightly ptotic (hanging) breasts, or in a client who is large and wide chested. Placing full profile breast implants in the case of a wide chest would impart a very unnatural "double cone" appearance. For women with a mid-range chest-wall diameter the choice is one of partiality. That is, the decision has to be made between projection, and cleavage. This is because lower profile implants with a wide base will naturally fill up the inner, otherwise known as the medial breast, and produce cleavage. Finally, it is mostly the anecdotal opinion of some authorities that full or high profile implants tend to generate less rippling.

Breast implants, whether silicone or saline interfere with mammography. Special views need to be obtained by radiologists experienced in the Eklund technique to visualize any abnormalities, however breast implants also project breast tissue from behind its base making any masses easier to feel. If you need to obtain a mammogram after your breast enlargement surgery, your radiology-mammography technologist must be informed about your breast implants so that in addition to obtaining additional views, special techniques may be used to minimize the chances for implant rupture.

There are guidelines for routine screening mammography established by the National Cancer Institute. The factors that are very important in determining the appropriate age for a first, and subsequent mammograms are age, patient history, and family history. Even if the guidelines suggest that you are too young, say 10 years younger than recommended, for mammography, it may be a good idea to have a "baseline" mammogram before, and six months after breast enhancement surgery. This is because breast enlargement surgery makes scars on the inside of the augmented breast which can calcify and fool mammographic examiners as to the cause of the calcium deposits. This would then lead to an unnecessary biopsy, which has the potential to add scars, distort breast tissue, or cause implant rupture. For NCI information on breast cancer screening, please see below.

Breast Cancer Screening

• Different tests are used to screen for cancer.
• Three tests are commonly used to screen for breast cancer:
• Mammogram
• Clinical breast exam (CBE)
• Breast self-exam (BSE)
• New screening tests are being studied in clinical trials.
• MRI (magnetic resonance imaging)
• Tissue sampling

Some screening tests are used because they have been shown to be helpful both in finding cancers early and in decreasing the chance of dying from these cancers. Other tests are used because they have been shown to find cancer in some people; however, it has not been proven in clinical trials that use of these tests will decrease the risk of dying from cancer.
Scientists study screening tests to find those with the fewest risks and most benefits. Cancer screening trials also are meant to show whether early detection (finding cancer before it causes symptoms) decreases a person’s chance of dying from the disease. For some types of cancer, finding and treating the disease at an early stage may result in a better chance of recovery.

Clinical trials that study cancer screening methods are taking place in many parts of the country. Information about ongoing clinical trials is available from the NCI Web site.

Three tests are commonly used to screen for breast cancer:

1.) Mammogram
A mammogram is an x-ray of the breast. This test may find tumors that are too small to feel. A mammogram may also find ductal carcinoma in situ, abnormal cells in the lining of a breast duct, which may become invasive cancer in some women. The ability of a mammogram to find breast cancer may depend on the size of the tumor, the density of the breast tissue, and the skill of the radiologist.

2.) Clinical breast exam (CBE)
A clinical breast exam is an exam of the breast by a doctor or other health professional. The doctor will carefully feel the breasts and under the arms for lumps or anything else that seems unusual.

3.) Breast self-exam (BSE)
Breast self-exam is an exam to check your own breasts for lumps or anything else that seems unusual.

If a lump or other abnormality is found using one of these 3 tests, ultrasound may be used to learn more. It is not used by itself as a screening test for breast cancer. Ultrasound is a procedure in which high-energy sound waves (ultrasound) are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissues called a sonogram.

New screening tests are being studied in clinical trials.

MRI (magnetic resonance imaging)
MRI is a procedure that uses a magnet, radio waves, and a computer to make a series of detailed pictures of areas inside the body. This procedure is also called nuclear magnetic resonance imaging (NMRI). Screening trials of MRI in women with a high genetic risk of breast cancer have shown that MRI is more sensitive than mammography for finding breast tumors.

MRI scans are used to make decisions about breast masses that have been found by a clinical breast exam or a breast self-exam. MRIs also help show the difference between cancer and scar tissue. MRI does not use any x-rays.

Tissue sampling
Breast tissue sampling is taking cells from breast tissue to examine under a microscope. Abnormal cells in breast fluid have been linked to an increased risk of breast cancer in some studies. Scientists are studying whether breast tissue sampling can be used to find breast cancer at an early stage or predict the risk of developing breast cancer. Three methods of tissue sampling are under study:

• Fine-needle aspiration: A thin needle is inserted into the breast tissue around the areola (darkened area around the nipple) to withdraw cells and fluid.
• Nipple aspiration: The use of gentle suction to collect fluid through the nipple. This is done with a device similar to the breast pumps used by nursing women.
• Ductal lavage: A hair-size catheter (tube) is inserted into the nipple and a small amount of salt water is released into the duct. The water picks up breast cells and is removed.

Screening clinical trials are taking place in many parts of the country. Information about ongoing clinical trials is available from the NCI Web site."

There have not been studies demonstrating conclusively, any benefit to massaging your breasts, however many surgeons feel that it helps diminish the chance for capsular contracture. Your body’s natural response to any implant is scar formation, the scar envelops the implant and may contract with time, causing firm capsule formation, and possibly palpable or even visible flaws. Massage is performed in the hopes of enlarging the space in which the implant moves about, thereby enlarging the size of the capsule. It should be performed slowly, and deliberately. It should be performed symmetrically, that is displacing the implant equally on both sides with each movement/repetition. Slowly press the implants inward, and hold for 10 seconds, release and repeat 10 times. Repeat the same pressing downward, and upward for the same number of repetitions.

The Style 410 McGhan Breast Implant is composed of a gel that is considered to be more cohesive than prior silicone breast implant designs. It is engineered to allow simulate the appearance, and tactile sensation of a natural breast. Its BIOCELL® textured surface is said to facilitate a gentle degree of tissue adherence. As explained before, this may keep the implant within the dissected surgical breast pocket, whether submuscular, or subglandular. The texture of the Style 410 breast implants may also serve to diminish the degree of capsular contracture. The fill used to construct the Style 410 implant consists of a more cohesive silicone, which not only more closely approximates the look and feel of natural breast tissue, but is less prone to significant soft tissue spread should a leak occur. The patented barrier within the implant is stated to minimize silicone diffusion out of the implant shell. This implant is also available in a wide variety of sizes, and thus dimensions, for attaining the desired result with respect to cleavage (medial fullness), upper breast pole fullness, and breast protrusion (projection).

Moderate Projection (Full Height)

Width	Height	Projection	Catalog Number
9.5 cm	10.0 cm	3.4 cm	27-FM 095
10.0 cm	10.5 cm	3.6 cm	27-FM 100
10.5 cm	11 cm	3.8 cm	27-FM 105
11 cm	11.5 cm	4.0 cm	27-FM 110
11.5 cm	12.0 cm	4.2 cm	27-FM 115
12.0 cm	12.5 cm	4.4 cm	27-FM 120
12.5 cm	13 cm	4.6 cm	27-FM 125
13 cm	13.5 cm	4.8 cm	27-FM 130
13.5 cm	14 cm	5.0 cm	27-FM 135
14 cm	14.5 cm	5.2 cm	27-FM 140
14.5 cm	15 cm	5.4 cm	27-FM 145
15 cm	15.5 cm	5.5 cm	27-FM 150

Full Projection (Full Height)

Grams	Projection	Catalog Number	Grams
155 g	3.7 cm	27-FM 095	160 g
180 g	4.0 cm	27-FM 100	185 g
205 g	4.2 cm	27-FM 105	220 g
235 g	4.4 cm	27-FM 110	255 g
270 g	4.6 cm	27-FM 115	290 g
310 g	4.8 cm	27-FM 120	335 g
350 g	5.1 cm	27-FM 125	375 g
395 g	5.2 cm	27-FM 130	425 g
440 g	5.3 cm	27-FM 135	475 g
500 g	5.6 cm	27-FM 140	535 g
550 g	5.8 cm	27-FM 145	595 g
605 g	6.1 cm	27-FM 150	655 g

Moderate Projection (Moderate Height)

Width	Height	Projection	Catalog Number	Grams
9.5 cm	8.6 cm	3.4 cm	27-FM 095	135 g
10.0 cm	9.1 cm	3.6 cm	27-FM 100	160 g