FDA Releases Report on Silicone Breast Implant Safety

By Rachel Walden — June 23, 2011

Today, the FDA released a report on the safety of silicone gel-filled breast implants, including recommendations for both women who have or are considering the implants and health care providers.

In 1992, silicone breast implants were taken off the market after the FDA decided that the manufacturers had not adequately addressed safety concerns. In 2006, the agency approved several styles of silicone breast implants made by two companies, putting the devices back on the market for cosmetic purposes, and asked that the makers conduct additional safety studies. Today’s release provides recommendations based on information from the studies that have been completed so far.

The FDA concludes that implants are “safe and effective” when used “as labeled,” and that “Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.”

Common local complications and adverse outcomes are listed as:

capsular contracture, reoperation, implant removal, and rupture or deflation of the implant. Other complications include wrinkling, asymmetry, scarring, pain, and infection at the incision site…Women with breast implants may have a very small but increased likelihood of being diagnosed with anaplastic large cell lymphoma.

Women considering implants are advised to be aware of the potential for these complications, and to have periodic MRI exams to detect “silent rupture” of the implant. These MRIs are supposed to be done at 3 years after implantation, and every 2 years after, which the agency warns “is costly and may not be covered by your insurance.”

The FDA materials also urge women to “recognize that breast implants are not lifetime devices” and “assume that you will need to have additional surgeries.”

The agency has provided this one-page consumer guide, Things to Consider Before You Get Breast Implants, a more detailed booklet on local complications and adverse outcomes, and a guide to questions to ask before getting implants.

One response to “FDA Releases Report on Silicone Breast Implant Safety”

  1. What is the most recent non industry, valid-reliable, non FDA, non manufacturer study on breast augmentation; and the downsides ?


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