Silicone Gel Breast Implants - Post FDA Approval Studies
Boston Breast Surgery Patients Can Participate in Mentor or Allergan Silicone Breast Implant Studies
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 NatrelleTM breast implants and 50% with Mentor’s Memory GelTM 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.