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Regulatory Focus™ > News Articles > Amidst European PIP Scandal, FDA Approves New Breast Implant Product

Amidst European PIP Scandal, FDA Approves New Breast Implant Product

Posted 09 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) approved Sientra, Inc.'s breast implant product on 9 March, making Sientra the third approved marketer for breast implant products in the US.

The approval comes amidst a world-wide scandal about breast augmentation products manufactured by French company Poly Implant Prothese (PIP), which has been under fire for manufacturing implants using industrial grade silicone. PIP's products have also been the subject of concerns of abnormally high rupture rates.

FDA noted that, "[a]s a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes."

In addition to other post-approval conditions, Sientra will:

  • continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
  • conduct a 10-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
  • conduct five case-control studies that will 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.

Read more:

FDA approves new silicone gel-filled breast implant

Regulatory Focus - French Breast Implant Scandal May Alter US Medical Device Regulation Debate


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