By Stuart A. Linder, M.D., F.A.C.S. | June 19, 2013
On June 14, 2013, Mentor approved its form of a gummy bear silicone gel implant, similar to the 410 highly cohesive Allergan silicone gel implant. These implants are now approved by the FDA and are for women 22 years of age and older for augmentation as well as reconstructive use. The FDA approved the Mentor Memory Shape gel implants after a six-year study of 955 women showing that there was reasonable safety and effectiveness to this specific implant. The most common complications include a capsular contracture, asymmetry and wrinkling. The data show that there was reasonable assurance of safety and effectiveness. They will continue with post-approval studies focusing on long-term safety and effectiveness of this specific implant. The Memory Shape Mentor Breast Implant has thicker cohesive gel associated with more cross-linking compared to previous cohesive gel Mentor implants. There is more chain linking of the silicone to each other which allows for a thicker, firmer and tighter shape to the implant. This will reduce visibility and rippling of this implant, especially in thin-chested women with minimal breast tissue coverage.
The FDA will require that Mentor continue post-approval studies to assess long-term effectiveness and safety of these new memory shape breast implants. They follow approximately 350 subjects who use the CPG style 321 memory shape medium height moderate profile implants and the 955 women who had the memory shape breast implants with the core study and they should be followed until their 10-year evaluation. The FDA also desires a new cohort study of 2500 women that will receive the Memory Shape Breast Implants in order to collect further information on the complications that may include reoperation, implant removal, rupture and capsular contracture and also looking at potential causes of autoimmune diseases, including rheumatoid arthritis as well as breast and lung cancer and reproductive complications.
There are now three cohesive gummy bear implants on the market that have been FDA approved, the Allergan highly cohesive 410 gel, the Mentor Memory Shape Breast Implants and the Sientra Highly Cohesive Silicone Gel Implants.
By Stuart A. Linder, M.D., F.A.C.S. | June 13, 2013
Haute MD Network, Haute Living magazine May / June, 2013 issue has Sir Richard Branson on the front cover. Inside this edition I am a part of the concierge access to premiere cosmetic specialists around the country.
On there online website www.hautemd.com I have also had the opportunity to contribute a few articles which I am very pleased to provide.
By Stuart A. Linder, M.D., F.A.C.S. | June 10, 2013
Patients present to my office every day with breast hypoplasia. The term breast hypoplasia simply means small breasts, hypoplastic breasts with minimal breast growth and development. This patient’s example on her preop shows that she has hypoplastic breasts with involutional upper pole atrophy, loss of tissue going to the upper breast. She also some skin laxity around the nipple areolar complex along the lower nipples. She underwent style 45 silicone cohesive gel Natrelle implants through a periareolar approach. Notice her postoperative appearance showing nice fullness to the upper breast; however, they are unnaturally round. This is because she had the implants placed in the subpectoral pocket and there is significant softening of the upper pole of her breasts with sloping. This has allowed her to have a beautiful round appearance to her breast with increased projection, reduced visibility and rippling that may be seen with lower profile implants in a woman with this thin amount of breast tissue. Breast hypoplasia is the most common definition for preoperative patients presenting for breast enhancement in my practice. Style 45 is the extra high profile cohesive silicone gel by Allergan Pharmaceuticals. This is not perfect for all women, but in this case it fit beautifully in that it reduced visibly rippling, allowed for increased AP projection and narrowing along the lateral breast to prevent increased fullness.
By Stuart A. Linder, M.D., F.A.C.S. | June 7, 2013
The other day it was brought to my attention that my book “The Beverly Hills Shape: The Truth About Plastic Surgery” was now available on Amazon in the Kindle Edition. Hard to believe that it’s been six years since LifeSuccess Publishing launched this edition (May 15, 2007). I’m very excited that Amazon has made my book accessable to people that prefer reading from a Tablet.
By Stuart A. Linder, M.D., F.A.C.S. | June 4, 2013
The video below presents a 13 year old ruptured Allergan low profile textured silicone implant. The rupture is due to a tear in the silicone shell of the implant. As pressure in applied to the ruptured implant you can see the silicone gel coming out.
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