If you are considering silicone breast implants, we encourage you to be a part of the PAS (Post Approval Study) or BIF (Breast Implant Follow-up).

This article will provide the details on the two FDA post approval silicone gel breast implant studies, being held in the United States. These studies are known by their acronyms PAS (Post Approval Study), and BIF (Breast Implant Follow-up). Both studies are currently enrolling patients. We will also provide some background information on the FDA approval of the silicone gel breast implants, currently being distributed in the United States.

On November 17, 2006 the FDA approved the marketing and distribution of Silicone Gel Implants by Mentor Corporation and Allergan Inc. (formerly known as Inamed Corporation). Mentor Corporation is located in Santa Barbara, California and Allergan is located in both Santa Barbara and Irvine, California. Both of these companies continue to manufacture both saline and silicone gel breast implants. Dr. Moss offers patients the choice of either.

Silicone gel breast implants are the most studied medical devices in history. Before the FDA approved them for distribution, extensive studies were required on the part of each manufacturer. Collectively the studies involved over 200,000 women and ran for almost 15 years. Dr. Roxanne Guy, president of the American Society of Plastic Surgeons stated at the time of approval, “The specialty of plastic surgery has always advocated that science should determine the availability of these devices, not emotion and special interests. Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care.”

At this point in time, silicone gel implants have been available to women in over 75 countries. In fact in many countries, the vast majority of patients choose to be implanted with silicone gel implants rather that saline filled implants. This is because they prefer the more natural feel that the silicone gel implant provides.

Although the FDA fully approved the silicone gel implants for distribution within the United States, they did so with the requirement that each company conduct a post approval study, enrolling approximately 40,000 patients into each study. The FDA has allowed each company (Mentor and Allergan) three years to complete the enrollment of these patients who have been implanted with silicone gel implants. Each patient will be enrolled in the study for a period of ten years.

Dr. Moss has agreed to participate in each company’s study for a number of reasons. First and foremost he feels strongly that having a choice of either type of implant, (silicone gel or saline filled), is in every patient’s best interest. Participation in these studies will allow Allergan and Mentor the capabilities of meeting their obligations to the FDA, and therefore ensure their availability in the future.

Secondly, breast augmentation is now the number one, most popular cosmetic procedure in the United States. According to the 2006 ASPS National Clearinghouse of Plastic Surgery Statistics, breast augmentation tops the list of most popular cosmetic surgeries with an estimate of 329,000 being performed in 2006. Participation in these studies will allow the FDA, Mentor and Allergen to gather the necessary information to ensure the continued safety of all breast implant patients.

And thirdly, well run clinical studies allow companies to constantly improve on their product offerings. The implants that are available to plastic surgeons and patients today are vastly superior to those available twenty or thirty years ago. It is only with the collaboration of manufacturers, plastic surgeons, patients and the FDA that these continued improvements can be made.

So what does Dr. Moss’ involvement in these studies mean to you as a patient? First of all, if you are opposed to any involvement in a study you may decline and still have Dr. Moss implant you with silicone gel implants if that is your choice. These implants are fully approved by the FDA so involvement in a study is not mandated and both corporations (Mentor and Allergan) allow patients to opt out. However, if you would like to participate, Dr. Moss and Carla (his wife and office manager) welcome your participation. Carla is coordinating both studies for Dr. Moss and will assist you in filling out your questionnaire.

Carla had breast augmentation with the silicone gel implants before they were approved by the FDA and is part of the Mentor “Adjunct Study.” Carla states, “By being part of the Adjunct study for Mentor Corporation I was able to experience how easy it was to participate. Therefore I am very comfortable assisting our patients with enrollment. I always take the time to clearly explain what each patient needs to do. I make sure they understand the process. I have not had one patient complain that the questionnaire was difficult or time consuming.”

In addition, because Dr. Moss is so enthusiastic about the silicone gel implants and therefore assisting Allergan and Mentor in enrollment of patients, he is providing all patients who register for the study a $50 check on their first post-operative visit. “I find that patients appreciate receiving this small token of my appreciation, for taking the time to fill out the questionnaire,” Dr. Moss states. “It is not financially burdensome for me, and it does help with enrollment. Currently we have been able to have 100% of our silicone gel patients, implanted since the study activation, enrolled in the post approval breast implant studies.” Dr. Moss adds.

Perhaps the biggest motivator to our successful enrollment is Carla’s enthusiasm for patient enrollment. She has worked for some of the major medical device manufacturers and her background is in medical device sales and implant consulting. She therefore recognizes the importance of assisting the manufacturers meet their enrollment goals.

Dr. Moss is implanting 50% of his silicone gel patients with Allergan’s Natrelle^TM breast implants and 50% with Mentor’s Memory Gel^TM breast implants. He feels that both brands are of equal, high quality. If any patient had a preference for either brand, he would gladly accommodate the patient’s choice.

Each manufacturer has designed its own post approval study for the FDA. Mentor’s study is referred to as the PAS (Post Approval Study) and Allergan’s is referred to as the BIF (Breast Implant Follow-up). From a patient standpoint there is very little difference between enrollment in the two different studies. Initially the biggest difference that patients experienced was that Mentor’s (PAS) initial questionnaire was a paper questionnaire while Allergan’s (BIF) initial questionnaire was an online questionnaire. However, both companies are now providing the surgeons’ offices with paper questionnaires that can be completed during the patients’ pre-operative visit. Allergan’s (BIF) initial questionnaire continues to be available online as well.

Both companies will be contacting the patients with yearly follow-up questionnaires via e-mail or US mail if necessary. Participation in either the BIF or PAS also requires three additional office visits during the ten year post surgical period. Allergan is providing BIF participants with incentives to fill out these yearly questionnaires and for keeping their office appointments.

• Mentor Post-Approval Study Brochure: “You’re Making a Difference”
• Allergan’s Breast Implant Follow-Up Brochure: “Be a Part of History”

If patients have any questions about breast augmentation, silicone gel or saline breast implants they should contact Dr. Moss’ office at 508-747-1322. If they have questions about either breast implant follow-up study they should specifically ask for Carla or e-mail her at carlamoss@capecod.net.

Learn More About Breast Implant Surgery in Boston

• See Breast Implant Before and After Pictures
• Read Breast Augmentation Information on Our Web Site

There are three commonly used incisions for the placement of breast implants. They are:
• Inframmary-within the breast fold, where the bottom of the
breast meets the chest wall (see diagram).
• Periareolar-around the nipple
• Transaxillary-within the armpit

The inframmary approach is the most popular incision used for breast augmentation and the one that Dr. Moss uses most frequently. Because it is concealed underneath the breast it is not evident in most patients, when they are viewed from a standing position. While some very flat-chested women, with no ptosis (sag) to their breast, may be able to view their inframmary crease before breast augmentation, it is usually not visible after the breasts have been augmented with implants. In fact, for most patients to view their own inframmary incisional scar after breast implantation, the patient needs to lift up her breast and twist her body so that the incision is visible in a mirror.

The inframmary approach is also popular with young women because it is felt to be less likely to interfere with breast feeding. The reason for this is that the incision is far away from the nipple/duct complex, thereby reducing the likelihood that these structures would be injured. The retention of nipple sensation is felt to be better with the inframmary approach for the same reason.

When performing breast augmentation with saline filled implants via the inframmary approach, Dr. Moss uses a 4 cm. incision. When performing breast augmentation using silicone gel filled breast implants, Dr. Moss uses a 5 cm. incision. The reason for the longer incision is that gel filled breast implant are inserted already filled, while saline filled implants are inserted empty, and the surgeon fills them with a syringe after they have already been placed in the breast cavity.

This picture shows the air being evacuated from what will be a saline filled breast implant. The implant is inserted into the breast cavity in an empty state and then filled with the desired amount of saline.

Dr. Moss will also accommodate patients who want their breast implants placed through a periareolar incision. This approach utilizes an incision that is made halfway around the areola. This incision runs from the 3 o’clock to the 6 o’clock to the 9 o’clock position around the areola (see diagram above). The length of this incision is obviously dictated by the patient’s individual anatomy. While this incision would be visible to the trained eye of a surgeon, it is usually not noticeable to most people, because it has been made at the junction of the areola and the normal dermis (skin) of the breast. Essentially the two different colors of the areola and the skin camouflage the presence of this scar.

Patients should be aware that the periareolar approach for breast augmentation is associated with a higher likelihood of inability to breastfeed. However, many physicians are comfortable with this approach and either offer it to patients or prefer it.

Both the inframmary and periareolar approaches are popular with surgeons, and the vast majority of plastic surgeons use either one of these techniques. One of the reasons for the popularity of the inframmary and periareolar approaches is because either approach provides excellent visibility of the breast cavity, during surgery. One of the most important surgical factors in breast augmentation is the control of any bleeding, in the cavity that has been made in the breast, for implant placement. Control of intra-operative bleeding is a surgical technique that all board certified plastic surgeons are very well trained in, and therefore something patients should understand is part of any surgery. However, the more visible the opened breast cavity is, the easier it is for the surgeon to perform the surgery.

The third and less commonly used approach is referred to as the transaxillary approach. The incision for this approach is made through the armpit (see diagram above). The patients who choose this approach are usually patients who do not want any scars whatsoever on their breasts. It is important however, that these patients understand that if their scars do not fade to an unnoticeable state, it could limit their wearing of sleeveless clothing, including bathing suits. Patients also need to understand that to a large measure, the quality of scarring is beyond the control of a surgeon. Some patient’s heal with better looking scars and some heal with very noticeable scars.

The other consideration that patients need to be aware of with the transaxillary approach is that if revisional surgery is required at a later date, another incision will need to be made at either the inframmary or periareolar location. The transaxillary approach does not provide sufficient access to the breast cavity to perform revisional surgery successfully. Therefore, these patients would then have scars on both their armpits and breasts. Dr. Moss has chosen not to perform breast augmentation surgery via the transaxillary approach.

Dr. Moss finds that the scars from breast augmentation surgery are rarely of any concern to his patients. However, he does carry a product called Scarguard, for the patients who want the very best possible scar. This is a clear liquid that is painted on the incision, twice a day, for three months. Dr. Moss allows patients to use this product at either 4 weeks or when the incision is completely healed, which ever comes first. This product contains Vitamin E, silicone oil, and a steroid, all of which can help improve the quality of the scar. This product is available for purchase, in his office, for a cost of $65. Dr. Moss usually finds that most breast augmentation patients only need one bottle.

Dr. Moss will always discuss with any prospective breast augmentation patient, the placement of incisions, and what she can expect. He will also answer any question concerning the surgical approaches of breast augmentation during the initial consultation. If any patient has a question concerning the surgical approach that they would like answered before scheduling an appointment with Dr. Moss, they should call the office and ask for Carla, Dr. Moss’ wife and office manager. Carla had her implants inserted via the inframmary approach and is very satisfied with her incisional scars.

Learn More About Breast Implant Surgery in Boston

• See Breast Implant Before and After Pictures
• Read Breast Augmentation Information on Our Web Site

On Friday, November 17th the FDA (US Food and Drug Administration) announced that it had issued approval, with conditions, to both Mentor Corporation and Allergan Corporation (the parent company of Inamed) to market silicone gel filled breast implants in the US, immediately. For the past 14 years the sale of gel filled breast implants has been restricted. Gel filled breast implants are the most studied device in history and the re-introduction to the US market has been applauded by many plastic surgeons. In the words of Richard D’Amico M.D., president-elect of the ASPS (American Society of Plastic Surgeons), This is first and foremost a validation of science. This is the most studied device in history, and the science has won out. Patients and their plastic surgeons will now have a choice of whether they use a silicone gel filled or saline implant. This is a choice that’s been available around the world for a long time and it’s good to know that American plastic surgeons and their patients again have the same options.

Dr. Moss has ten years experience implanting gel filled breast implants. He implanted gel filled breast implants frequently, before the FDA restricted their sale in 1992. Dr. Moss points out, “Extensive studies have failed to link silicone gel filled breast implants to autoimmune diseases such as lupus, rheumatoid arthritis or other diseases. It is also important that patients understand that the gel filled breast implants that have just been approved for sale, are very different from the ones that the FDA pulled off the market.”

These gel filled implants from both Mentor and Allergan are of another generation silicone gel filled breast implant. The silicone gel filled implants that received market approval from the FDA are of a cohesive nature not a liquid or semi-liquid nature. Cohesive implants are designed so that if there is a rupture of the outer silicone elastomer shell, the filler binds onto itself, thereby reducing the probability that the silicone will travel beyond the breast implant capsule. The breast implant capsule is the natural occurring fibrotic sheath that the body produces around any foreign body material, including breast implants. Dr. Moss uses Mentor breast implants exclusively. Not only do I prefer the implants (saline filled or gel filled) that Mentor produces, I find that Mentor Corporation is very supportive of surgeons and patients and this allows me to provide the best possible care and results for my patients.

The gel filled breast implants manufactured by Mentor, that were approved by the FDA carry the trade name of MemoryGel. MemoryGel implants contain a proprietary cohesive polymer, not a liquid or semi-liquid. It holds together uniformly, while retaining the natural give of actual breast tissue. These MemoryGel implants are widely used by doctors and patients in over 75 countries. Nearly two decades of extensive research involving hundreds of thousands of patients and their physicians supports the safety and efficacy of this product.

Dr. Moss feels that while there is a tremendous amount of written information that he will provide to patients who are weighing their options between silicone gel filled and saline filled breast implants, there are a few important points that patients should consider, when making their choice:

1) Silicone gel filled breast implants feel more natural than the saline filled implants that have a slightly firmer feel.

2) The minimum age for patients to have implantation with gel filled breast implants is 22 years of age. The minimum age for patients to have implantation with saline filled breast implants is 18 years of age.

3) Silicone gel filled breast implants require a slightly larger incision than the saline filled breast implants at the time of implantation. When using the inframmary approach (located underneath the breast, where the breast meets the chest wall), Dr. Moss uses a 4 cm incision for implantation of the saline filled. He will be using a 5 cm incision for implantation of the silicone gel filled implants.

4) Silicone gel filled breast implants are more expensive to purchase and therefore the cost of implantation with silicone gel filled implants will be at least $1000 more.

5) It is recommended that patients who have implantation with gel filled breast implants have an MRI three years after implantation, and then every two years after that. Patients do need to understand that their health insurance may not cover this test.

Dr. Moss’s wife Carla was recently implanted with these MemoryGel breast implants. She experienced an uncommonly early deflation in one of her saline filled implants and so it was decided that the MemoryGel breast implants would be a good choice for her revision surgery. She received her MemoryGel implants before the FDA approval, as part of the adjunct study that Mentor was performing for the FDA. Carla is very willing to speak to prospective patients about her experience with both styles of Mentor breast implants (saline filled and gel filled).

Carla states, “The biggest difference between the two styles of implants is that the gel filled implants are more natural feeling. I was also very happy with the saline filled implants. However, the early deflation of one implant provided me the opportunity to qualify for the adjunct FDA study, so that was what I decided to do. The revisional surgery was very easy for me. I was able to control the discomfort with only Tylenol and felt comfortable within a few days, to the point that I even stopped the Tylenol. I also do not find the incisional scars underneath my breasts more noticeable than the original scar for the saline implants, even though it is slightly longer.

Because I had enrolled in Mentor’s Enhanced Advantage Limited Warranty and my revision was due to an implant deflation, the coverage was enough to fully cover the costs of my revision surgery. In addition, Mentor has a lifetime replacement policy for all deflated breast implants. Patients who experience a deflation can receive a pair of implants of equal value at no charge or upgrade to a more expensive implant, simply by paying the difference in cost. I found the Mentor implant warranty was very generous and flexible,” Carla Moss explained.

Concerning which type of breast implant a patient should choose: silicone gel filled implants versus saline filled implants, Dr. Moss stated, “I have a very busy cosmetic surgery practice, much of which is breast augmentation surgery. One of the reasons that my patients are so happy is that I provide them choices where possible, such as size and shape of implant. I give my patients guidance so that they can make the choices that are best for them. I intend to do the same when it comes to their decision concerning silicone gel filled breast implants versus saline gel filled breast implants. In the end, because my patients and I have more choices, I expect that the recent FDA approval of silicone gel filled breast implants will allow me to provide an even higher level of patient satisfaction, than ever before.”

Learn More About Breast Implant Surgery in Boston

• See Breast Implant Before and After Pictures
• Read Breast Augmentation Information on Our Web Site