Reports of breast implant 'illness' spur FDA safety review

Alia Paavola - Print  | 

The FDA has started to re-examine breast implant safety and the reports from thousands of women who claim the implants are causing problems like debilitating joint pain and fatigue, according to The New York Times.

The claims that the implants can cause illness have long been disputed by physicians and implant manufacturers. However, a growing body of evidence suggesting otherwise is causing the FDA to review the safety of the implants.

On March 19, the FDA sent a letter warning two breast implant makers that they failed to conduct adequate studies to understand the long-term effects on women's health. The agency cautioned that the devices may be removed from the market if the research isn't properly carried out.

In a separate news release March 15, about the safety of a broad array of medical devices, the agency acknowledged that implantable devices may make some people ill.

"A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices," the agency said. Those effects can include "inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life."

The FDA is working to understand the safety of specific materials used in medical devices. Silicone, used in implants, is one of those materials.

The agency will hold a two-day meeting about breast implants next week.

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