MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

Cheryl Clark, for HealthLeaders Media , July 5, 2012

But all hell broke lose four years ago when a raft of failure and toxicity issues surfaced among patients who had received two major MoM devices sold under the name DePuy, the ASR Acetabular System, and the ASR Hip Resurfacing System, both manufactured by Johnson & Johnson. In a statement announcing it was recalling these devices in 2010, DePuy officials acknowledged that 12% to 13% of patients required revision surgery after five years.

Class action lawsuits tumbled in.

Then more complaints and concerns came flooding in from many more patients, including many who received other MoM protheses made by five manufacturers.  Many patients, like Steve Lorenz of Whitehall, PA, said that when they told their doctors that they weren't recovering from their hip surgeries, but were getting worse, they were brushed off.

"He disregarded every symptom, and then he equated what happened to him when he took a Pilates class with his wife," recalls Lorenz' wife, Pat, who testified before the FDA panel about the surgeon's reaction to her husband's complaints.

How did hundreds of thousands of potentially unsafe devices get into the market?

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1 comments on "MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA"

carol (7/6/2012 at 3:36 PM)
The panel has said that they won't ban the devices, but they did have recommendations for more limited use. They said that people who show signs of failure (swelling, pain, etc.) should have X-rays and blood testing for metal ions, a guideline that UK regulators already issued awhile back. They also said that the FDA should provide some kind of reference range for the metal ion tests, since there is currently no standard




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