FDA allows silicone breast implants to remain on market

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FDA allows silicone breast implants to remain on market

Five years after they were allowed back on the market in this country, the FDA is saying they are confident silicone breast implants are indeed safe, although the very small risks are still very real.
The Wall Street Journal reports that Food and Drug Administration announced that early findings from an analysis of safety issues and adverse events associated with silicone-gel breast implants revealed no new concerns.
Therefore, the agency said it will allow the devices to remain on the market.
The Journal quotes the FDA as saying in the announcement, “Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use.”
The Los Angeles Times notes that the FDA was “criticized by consumer groups in 2006 for approving the implants after a 14-year hiatus because of widespread fear that they caused a range of illnesses.”
But, the FDA said the analysis “indicates that they have a ‘reasonable assurance of safety and effectiveness’ when used properly. … ‘What we can say is the current data doesn’t indicate that silicone gel-filled breast implants are linked to breast cancer, connective tissue disease or infertility,'” FDA’s Center for Devices and Radiological Health Director Dr. Jeffrey Shuren “said in an interview.”
The Times points out that the analysis was conducted by implant manufacturers: “Santa Barbara-based Mentor Worldwide and Irvine-based Allergan Inc., which were required to conduct post-approval studies on more than 80,000 women over 10 years.”
The National Journal reports that FDA’s analysis summarizes “four years of data after the 2006 approval of the implants, which had been scrutinized for evidence they could leak and cause cancer, fibromyalgia, rheumatoid arthritis, and a range of other ills.”
The study is expected to continue until 2016.
The AP reports that the FDA also made several cautionary statements.

  • For one, “don’t expect breast implants to last for life”: The agency warned that about “20 percent to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years.” For reconstruction patients, the “number is even higher at 40 to 70 percent.”
  • The FDA also emphasized that women making decisions on the gel implants need to understand that they come with complications, including “painful scar tissue and ruptured implants.”
  • Other problems include implant “wrinkling and a lopsided appearance.”

Additionally, Bloomberg News reports that the FDA “reiterated its warning from January that as many as 60 of the five million to 10 million with breast implants globally have developed a rare type of cancer called anaplastic large cell lymphoma.”
“This risk is ‘profoundly small,'” Dr. Shuren stressed.

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