FDA Approves Silicone Gel-Filled Breast Implant, Requires Postapproval Safety Studies

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(ChemotherapyAdvisor) – The U.S. Food and Drug Administration approved a new silicone gel-filled breast implant on March 9. The implant, manufactured by Sientra Inc., is indicated for breast augmentation in women at least 22 years of age and breast reconstruction in women of any age.

Three FDA-approved silicone gel-filled breast implants are now available in the U.S., manufactured by Allergan, Mentor, and Sientra. “Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, MD, MPH, deputy director for science in the FDA's Center for Devices and Radiological Health.

“It's important to remember that breast implants are not lifetime devices,” he added. “Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included capsular contracture, re-operation, implant removal, asymmetry, and infection.

In June 2011, the FDA released a report that included preliminary safety data from postapproval studies from earlier breast-implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants. These studies include:

  • Continued follow-up of the 1,788 clinical trial participants in Sientra's premarket study for an additional seven years;
  • Conducting a ten-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
  • Conducting five case-control studies to evaluate the association between Sientra's silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

“The design of these postapproval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Dr. Maisel. “The FDA is committed to working with breast-implant manufacturers to collect useful postmarket data on long-term safety and effectiveness.”

Sientra Inc. is based in Santa Barbara, Calif.

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