Medical Devices

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

Description and Detailed Information Links:

Sientra’s Silicone Gel 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. They are approved for breast augmentation in women age 22 or older and for breast reconstruction in women. They are also used in revision surgeries, which correct or improve the result of an original surgery.

Summary of Post-Approval Studies:

As conditions of approval, the FDA required Sientra to conduct five post-approval studies to characterize the long-term performance and safety of the devices. The post-approval studies for Sientra’s silicone gel-filled breast implants included:

  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 Study - 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.

In addition, explant analysis will be conducted for all Sientra silicone gel-filled breast implants that are removed from patients and returned to the manufacturer.
 

Page Last Updated: 02/21/2013
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