Latest on silicone gel-filled breast implants

December 12, 2011

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The latest report on breast implants from the U.S. Food and Drug Administration (FDA) updates the clinical and scientific information for silicone gel-filled breast implants.

The report includes preliminary safety data from studies conducted by the implants manufacturers Allergan and Mentor, as a condition of their November 2006 approval.

The report confirms that silicone gel-filled breast implants are safe and effective, but urges women to fully consider and understand the risks prior to having implant breast augmentation or reconstruction.

According to the report, women should be aware that:

  • Breast implants are not meant to last for a lifetime and that the longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients receiving implants for breast augmentation will need them removed within 10 years of implantation. 1 in 2 patients, who received implants for breast reconstruction, will need to have them removed 10 years after implantation.
  • The most frequent complications are capsular contracture (hardening of the area around the implant), additional surgeries and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

According to FDA, preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis.

However, there is a need for longer studies, with more women involved, in order to rule out these and other complications.

In conclusion, the FDA recommends that:

  • Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture.
  • Women should notify their health care professionals if they develop any unusual symptoms.
  • Women enrolled in a manufacturer-sponsored post-approval study continue to participate in order to help collect information about the long-term rates of complications.

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