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Medical News and Perspectives |

Advocates Call for FDA to Take Tougher Stance on Postmarket Safety Studies

Bridget M. Kuehn
JAMA. 2011;306(15):1639-1642. doi:10.1001/jama.2011.1477.
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With high dropout rates threatening the viability of 2 postmarket safety studies of silicone breast implants, the US Food and Drug Administration (FDA) in August convened an advisory committee hearing to determine the best way to assess these devices in the absence of results from these studies. The agency required manufacturers to conduct such research as concerns about the safety of these devices emerged.

The meeting was closely watched by consumer advocates and clinical experts, who say it highlights the ongoing difficulties the agency has had in ensuring that device makers follow through on required postmarket studies of medical devices. Even though such research is frequently required by the agency as a condition of approval, companies often fail to follow through. Critics argue that tougher sanctions from the agency or greater collaboration among government agencies to ensure collection of the necessary data may help resolve this problem.

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Although rupture and other common adverse events associated with silicone breast implants have been well documented, there is a dearth of information about rare or longer-term problems associated with the devices.

(Photo credit: Boilershot Photo/www.sciencesource.com)

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