US Lawmakers Ask FDA For Breast-Implant Data

– The US Food and Drug Administration (FDA) has been asked to provide a powerful congressional committee with records regarding two companies’ breast implants, and information about a criminal investigation of one maker for manufacturing violations.

 In a letter to FDA Deputy Commissioner Lester Crawford sent on Thursday, Louisiana Republican Rep. Billy Tauzin and Pennsylvania Republican Rep. James Greenwood asked for records relating to studies conducted by Mentor Corp. and Inamed Corp., two makers of saline-filled breast implants. Reps. Tauzin and Greenwood respectively are chairs of the House Energy and Commerce Committee and its oversight subcommittee.

The lawmakers’ request follows an FDA advisory panel meeting that took place earlier this week, during which the companies reported that up to a quarter of women receiving breast implants for cosmetic reasons need replacement operations within five years. The reported numbers for women undergoing reconstructive surgery were even higher.

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