3rd Silicone-Gel Breast Implant Approved for U.S. Market

Until recently, only two silicone-gel breast implants have passed through the extensive and rigorous FDA approval process for use in the United States. <Earlier this month, however, pharmaceutical giants Allergan and Mentor were joined by Sientra, a company based in Santa Barbara, California, which manufactures breast implants.

The device has been approved for breast augmentation in women 22 and older, as well as breast reconstruction surgery at any age. But how does the FDA approval process work, and how can consumers be sure that the new implants are safe?

Silicone implants are medical devices that undergo a variety of tests and studies before they gain approval by the Food and Drug Administration. Before Sientra’s implant could be approved, three years of data from clinical studies on nearly 1,800 patients were analyzed. Complications from the implants were uncommon and similar to what is expected from the Allergan and Mentor lines.

But don’t think that the studies are stopping just because the implant has gained FDA approval. Sientra will be conducting a series of studies to verify the safety and effectiveness of its implants for many years to come. These include:

  • follow-ups with current study participants over the next 7 years to check for long-term complications
  • a 10-year study to monitor potential long-term complications such as rheumatoid arthritis and certain cancers
  • five studies to examine potential links with connective tissue disorders, neurological diseases, brain cancer, cervical or valvular cancer, and lymphoma

Dr. William Maisel, deputy director for science in the FDA Center for Devices and Radiological Health, believes that these studies will likely reinforce existing positive evidence. “Data on these and other approved silicone-gel filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” he says.

Dr. Jeffrey C. Salomon, a clinical professor of plastic surgery at Yale University School of Medicine, agrees with that assessment. He told HealthDay in an interview: “Sientra is a brand that has been used in Brazil for an extended length of time, and I doubt that there were concerns about cancer, otherwise the FDA would have not approved them.”

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Posted in: Breast Enhancement

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