FDA Approves Silicone Gel Filled Breast Implants
Boston breast implant information, read more about FDA approval of silicone gel filled breast implants and how to get breast implants.
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.”