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Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com.

Pennsylvania woman to address FDA panel on husband’s hip-replacement recall

June 27, 2012|By David Sell and INQUIRER STAFF WRITER

Steve Lorenz works as a foreman at a cement company near his home in Whitehall, Pa., and has been active all of his life, but that life has been different since he had both hips replaced.

“Sitting with him, watching TV, he would drive me crazy because he is always moving,” Pat Lorenz said of her husband’s discomfort. “He often said it felt like he was sitting on marbles.”

Pat Lorenz is scheduled to speak Wednesday at a U.S. Food and Drug Administration advisory panel hearing in suburban Washington. The panel is looking into the problems of metal-on-metal hip-replacement systems.

In August 2010, Johnson & Johnson‘s DePuy Orthopedics division recalled its metal-on-metal ASR hip system, which was implanted in Steve Lorenz and other patients. The Lorenzes are among the thousands who have filed lawsuits against J&J.

Recalling a replacement hip still in a box is one thing. Doing a “revision,” in medical parlance, means major surgery again, and Lorenz needs two. Beyond the pain, bruising, stiffness, and stooped gait that he has now, Lorenz is among the patients with blood problems that some attribute to the metal-on-metal hips.

The metal ball and socket rubbing against each another have, in some cases, released chromium and cobalt into the bloodstream at higher than normal levels. But “normal” is under debate because the United States is behind in establishing recognized clinical procedures and standards for testing of such metals. The effects are also unclear. This week’s two-day FDA meeting is supposed to discuss how to address that problem.

The United Kingdom’s health-care regulatory agency issued a warning in February alerting surgeons to the blood problem. The FDA’s pre-meeting report said of the British warning, “According to management recommendations, revisions should be considered in a patient if imaging results are abnormal and/or if the whole blood metal ions levels (i.e. chromium and cobalt) are greater than 7 parts per billion and rising.”

One of Steve Lorenz’s recent blood tests showed 17 parts per billion, according to Pat.

“Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need,” DePuy spokeswoman Mindy Tinsley said by e-mail. “DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. ASR patients should contact the ASR Help Line at             1-888-627-2677       for assistance.”

Lorenz, 52, had his left hip replaced in December 2008 and right hip replaced in February 2010. When the couple visited his surgeon after getting the recall notice, they were met with what Pat described as an “entourage” of staff members, though she did not think a lawyer was among the group flanking the surgeon.

“He quoted what his malpractice insurance is and what the increase will be,” she said, adding that finding doctors to consider the second set of operations was not easy. Lorenz said a person at one practice told her, “No one wants to clean up somebody else’s mess.”

Pat Lorenz said the family had used Steve’s company health insurance at the start of this episode, but they are now using insurance provided by her employer, Lafayette College. Out-of-pocket costs run high. And Steve had to go back to work once his sick leave expired, even though he was still in pain. If he has more surgery, he probably will need to have both hips operated on at once, so he will need rehabilitation. All of that costs money.

“On anything else, you might throw in the towel and give up,” Pat said of exposing the problem. “But when it’s your health. … I don’t want to be a widow in five years or nursing him through leukemia.”