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Information on Silicone Gel-Filled Breast Implants (Added Sientra?s Silicone Gel Breast Implants - P070004)

Fri, 03/09/2012 - 1:38pm
U.S. Food & Drug Administration

Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.

FDA-Approved Silicone Gel-Filled Breast Implants:

Allergan Natrelle (Premarket application number: P020056) (Approved November 2006)

Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006)

Sientra’s Silicone Gel Breast Implants (Premarket application number: P070004) (Approved March 2012)

Summary of Safety Information:

Woman holding a pair of breast implants in her hands. Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove them.

The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

MRI continues to be the most effective method of detecting silent rupture of silicone gel-filled breast implants. If you have silicone gel-filled breast implants, the FDA recommends that you receive MRI screening for silent rupture 3 years after receiving your implant and every 2 years after that.

There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.

In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. This update included preliminary results of the studies required by the manufacturers at the time of approval as well as a review of other available scientific data.

The Summary of Safety and Effectiveness details safety information known at the time of FDA approval. As the FDA learns of new safety information, it requires companies to update their product labeling. The most current safety information about silicone gel-filled breast implants can be found in the labeling.

For more information about the safety of silicone gel-filled breast implants:

Post-Approval Studies (PAS):

As conditions of approval of silicone gel-filled breast implants, the FDA required each manufacturer to conduct six post-approval studies to characterize the long-term performance and safety of the devices. Due to the length of the studies required by the FDA, they have not all been completed. The post-approval studies for silicone gel-filled breast implants included:

  1. Core Post-Approval Studies (Core Studies) – To assess long-term clinical performance of breast implants in women that enrolled in studies to support premarket approval applications. These studies were designed to follow women for 10 years after initial implantation.
  2. Large Post-Approval Studies (Large Studies) – To assess long-term outcomes and identify rare adverse events by enrolling more than 40,000 silicone gel-filled breast implant patients, following them for 10-years.
  3. Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
  4. Focus Group Studies – To improve the format and content of the patient labeling.
  5. Annual Physician Informed Decision Survey (Informed Decision Study) – To monitor the process of how patient labeling is distributed to women considering silicone gel-filled breast implants.
  6. Adjunct Studies – To provide performance and safety information about silicone gel-filled breast implants provided to U.S. women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.

The Allergan Core Study enrolled 715 patients and the Mentor Core Study enrolled 1,008 patients. Allergan follow-up rates at 10 years post-implant are 66 percent. Mentor follow-up rates at 9 years post-implant are 59 percent. Longer term follow-up is available for the Allergan Core Study participants because the study began enrolling patients approximately 20 months before the Mentor Core Study.

Each company enrolled more than 40,000 women in their Large Studies. In these studies, Allergan has collected 2-year data for 60% of participants, and Mentor has collected 3-year data for 21% of participants.

More information about the results of these post-approval studies is provided in the Update on the Safety of Silicone Gel-Filled Breast Implants.

For Sientra’s silicone gel-filled breast implant, the FDA required the manufacturer to conduct a series of post approval studies including:

  1. Core Cohort Study - To assess long-term clinical performance of breast implants in the 1,788 women that enrolled in studies to support premarket approval applications. Prior to approval, this study yielded three years of data, and it is designed to follow these women for a total of 10 years after initial implantation.
  2. US Post Approval Study- To assess long-term outcomes by enrolling more than 4,700 silicone gel-filled breast implant patients and following them for 10-years
  3. Case-Control Studies - To identify rare adverse events by enrolling over 10,000 women in five case/control studies on rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma .
  4. Continued Access Studies - To collect additional safety and effectiveness data from women who received these implants prior to approval but outside of the Core Cohort Study.
  5. Focus Group Study - To improve the format and content of the patient labeling.

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