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

The holidays are here and everyone wants to look their best. Now! And with all the shopping, parties, and decorating, most people don’t have a lot of spare time. So what’s the answer? If you were to ask Dr. Moss he would tell you that facial injectables: BOTOX, Restylane, and Radiesse would be excellent choices for someone who wants to look better within a few days, and doesn’t have much time to spend doing so.

This article was written by Dr. Moss’ wife, office manager, and avid fan of facial injectables. This article will provide you with some basic information about these products, treatments and the results you may achieve. It will also offer you some with some “down to earth” tips on choosing a doctor for your injections.

BOTOX® Cosmetic is a purified protein that is administered via a few tiny injections. It is used to treat the frown lines between the eyes, the horizontal forehead lines, and the crow’s feet. It can also improve a droopy eyebrow. There is very little discomfort associated with this treatment and patients usually see results within four days. BOTOX® Cosmetic is considered to be a very effective treatment by physicians and patients. It is the number one cosmetic treatment provided in the United States.

Dr. Moss provides a “gold standard of treatment” when administering BOTOX® Cosmetic. Before any patient receives their injection, Dr. Moss discusses with the patient what the goals of the treatment are. He wants to make sure that he completely understands what the patient is bothered by and what she/he wishes to achieve. In addition, he feels it is important that before he starts any treatment, that the patient has a clear understanding of what can be achieved.

Dr. Moss pays particular attention to patient comfort during all injectable treatments. He uses a very tiny 32 gauge needle, which he purchases just for BOTOX® Injections. This has considerably reduced discomfort of patients during their injections. In addition, the saline that he uses to dilute the BOTOX® (BOTOX® is shipped as a dry powder) contains a preservative. This has been reported to cause less discomfort than saline that does not have a preservative. And lastly, when he mixes the BOTOX® with saline he does so in a way to have the injectable material at its strongest solution. This results in the actual volume needed to be injected being lower, while maintaining the strength of the BOTOX® being injected.

While most patients do not need any type of an anesthetic for BOTOX® injections, Dr. Moss does have a topical anesthetic cream that he or staff members can apply, prior to injection. Dr. Moss also has cold gel packs for all patients to apply after their injections if they so wish. Patient comfort is important to Dr. Moss. It is not unusual for patients to comment on how much more comfortable their treatments are with Dr. Moss.

Another important aspect to any facial injection treatment, including BOTOX® is the effectiveness of the treatment. BOTOX® injections are considered to have a high efficacy. However, the amount of BOTOX® that is injected needs to be at a sufficient level to produce the required results. The BOTOX® product itself is very expensive and is available from only one manufacturer. Dr. Moss always injects a sufficient amount of BOTOX® (usually 25 or 35 units) to get the expected result. He does not under treat and he always purchases genuine BOTOX® Cosmetic product from the manufacturer, Allergan.

The skill and training of the person providing your BOTOX® injections is critical to a good result. Dr. Moss is fully trained in BOTOX® injections and he is also a board certified plastic surgeon. This means that he has one of the highest levels of understanding of the facial anatomy of any of the specialties that provide BOTOX® injections to patients. Plastic surgeons are one of the two specialties trained to perform facelifts. (The other specialty is facial plastic surgeons.) This means that Dr. Moss understands the anatomy including the muscles and nerves underneath your facial skin. And that is what BOTOX® Cosmetic actually treats. Again, Dr. Moss provides the “Gold Standard of Care.”

Cost is another issue for patients receiving BOTOX® injections. BOTOX® lasts on average for 4 months. Therefore cost can be important, especially on a long-term basis. A patient can choose to not be retreated with BOTOX®, however they should expect their facial wrinkles to return. A complete listing of Dr. Moss’ pricing for BOTOX® is provided on his website: www.drmossthebeautyboss.com. A standard injection of BOTOX® for 1 site costs $375.00. Dr. Moss’ staff will review all costs over the phone with you and you will always be provided with an actual cost before you receive your injections. Dr. Moss wants you to be completely informed of the prices and costs at all times.

Dr. Moss’ wife has had BOTOX® injections many times in all three sites, (forehead, frown lines between eyes, and crow’s feet). Feel free to call her if you have any questions and are considering BOTOX®.

The other category of facial injections is referred to as “facial fillers.” The two products that Dr. Moss uses in this category are Restylane® and Radiesse™. These two products do not compete with BOTOX® but rather can be used to complement the results achieved with BOTOX®. A patient can also receive Restylane® or Radiesse™ without receiving BOTOX®.

Dr. Moss uses Restylane® or Radiesse™ to treat the wrinkles and lines in the lower part of the face. Both Restylane® and Radiesse™ can be used to soften the nasolabial lines that run from the nose to the mouth or the marionette lines that run down from the mouth. In addition, Restylane® can also be used to plump up the lips. Radiesse™ is not used to plump up the lips because it tends to form nodules when used in this location.

Dr. Moss is very experienced in the technique of facial filler injections. He has been providing this service for approximately 20 years. The original fillers that were used back then were the collagen products. Because Restylane® and Radiesse™, newer products to the market, last considerably longer, most patients no longer request collagen injections. Restylane® lasts on average 6 months while Radiesse™ lasts on average 1 year.

An important factor in the treatment with “facial fillers” is the local anesthetic that is provided at the time of treatment. Unlike BOTOX®, which requires no anesthetic for treatment, facial filler injections do require some type of local anesthetic in most patients. Dr. Moss is well trained in providing a “dental block” with a Novocain-like product to patients prior to their facial injections. He first uses a topical anesthetic on the gums to make the “dental block” itself as easy as possible for patients. Then after the numbing injections, he will have all patients wait at least 15 minutes before injecting with any filler. He has found that patients feel very little discomfort if he provides enough time for the “dental block” to take effect.

In addition to the dental block, Dr. Moss also applies a topical numbing cream to the facial sites that are to be injected with Restylane® or Radiesse™. Again, he finds this little bit of extra attention reduces treatment discomfort to the absolute minimum. Occasionally, Dr. Moss has a patient who wishes to forgo the “dental block” when receiving Restylane® or Radiesse™. Dr. Moss will perform “facial filler” injections without “dental blocks” if that is the patient’s choice. All patients receive a cold gel pack at the end of their injections to help minimize bruising. There is no additional charge for any of the local anesthetic services provided with the facial filler injections.

Dr. Moss provides the same high level of service with all facial filler injections. He will sit down with the patient in the examination room and ask what areas of her face she would like to see the wrinkles reduced and softened. He always tries to correct the areas that bother the patient. In addition, Dr. Moss will provide guidance to the patient so that she/he receives the best possible result.

Dr. Moss prices Restylane® and Radiesse™ treatments by the syringe. While these products are very expensive, he does offer them at attractive pricing. Dr. Moss charges $550 for one, 1.0ml syringe of Restylane®. He charges $1000 for two syringes of Restylane®, when injected at the same visit. He charges $750 for one 1.3ml syringe of Radiesse™. Patients can choose to have treatment with multiple syringes if they feel that the correction they want warrants more than one syringe. Patients can also elect to come back for additional syringes at a later date if they feel they want to further improvement. Carla Moss, Dr. Moss’ wife has had multiple injections of both Restylane® and Radiesse™, and is happy to discuss these treatments with interested callers.

If you feel that facial rejuvenation is something you would like to have Dr. Moss perform for you, please call 508-747-1322 or 781-337-2421, to set up an appointment.

Learn More About Cosmetic Injectables in Boston

• Read About Non-Surgical Procedures in Boston
• Get Information About Cosmetic Injectables in Boston

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