Bloomberg News

Hip Implants Targeted for Health-Device Probe by House Democrats

October 12, 2011

Oct. 12 (Bloomberg) -- House Democrats asked Republican leaders to investigate the safety of metal-on-metal hip implants made by companies such as Johnson & Johnson and stents used to clear clogged brain arteries.

Energy and Commerce Committee Democrats led by Representative Henry Waxman of California urged Republicans in a letter today to hold hearings on the devices as the panel focuses on reauthorizing industry user fees that fund U.S. regulators’ review of new medical products. Past hearings have focused on delays in device approvals, the letter said.

“Looking further into the ‘metal-on-metal’ hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices,” the Democratic lawmakers wrote.

“Tiny metal particles may wear off” metal-on-metal hip implants and enter the bloodstream from friction of the ball and cup, the Food and Drug Administration said. The agency has received more than 5,000 complaints about the implants, according to the Democrats’ letter. About 500,000 patients have received metal-on-metal hips.

About 15 percent of patients implanted with the Wingspan stent system to open a clogged brain artery and at high risk for a second stroke had a stroke or died within 30 days of the procedure, compared with almost 6 percent of patients treated without a stent, according to a National Institutes of Health study released Sept. 7 by the New England Journal of Medicine.

Approval Process

The stents from Natick, Massachusetts-based Boston Scientific Corp. were approved in 2005 under a humanitarian exemption that lets a maker bypass full premarket approval when the condition affects fewer than 4,000 people, according to the letter. The company last year sold its neurovascular unit, including the Wingspan stents, to Kalamazoo, Michigan-based Stryker Corp.

Representatives Frank Pallone of New Jersey, Diana DeGette of Colorado and John Dingell of Michigan also signed the letter to Fred Upton, a Michigan Republican and chairman of the committee. Staff members for Upton didn’t return a request for comment on whether he would investigate the devices.

The hip implants were cleared for sale through the agency’s device approval process known as 510(k), for which clinical data isn’t typically required and device makers instead show the product is similar to one already on the market.

Johnson & Johnson, based in New Brunswick, New Jersey, and Boston Scientific didn’t immediately return requests to comment.

--Editors: Steve Walsh, Andrew Pollack

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.


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