Congressional subcommittees in both the House and Senate held hearings last week on the safety of the FDA approval process for medical devices in light of the global recall of defective hip replacements manufactured by DePuy Orthopaedics, Inc. As we reported on January 26, numerous product liability lawsuits have been filed against DePuy alleging that metal parts in DePuy's ASR hip implants broke down, leaving patients with elevated levels of cobalt in their blood and requiring them to have additional surgeries to replace the faulty hip implants.
DePuy voluntarily recalled the defective hip replacements in August 2010, but critics charge that the company knew of serious problems with the medical devices long before the product recall. They also charge that DePuy paid substantial "consulting fees" to surgeons in order to influence them to use the devices.
Such was the story of one patient who testified before the U.S. Senate's Special Committee on Aging on April 13.
"Recalls were for dishwashers and cars, not body parts," the woman said, describing her horror and anger at learning her defective hip replacement had been recalled.
Defective hip replacement breakdown could have caused infertility, but replacing it led to other problems
The woman who testified before the Senate committee on Wednesday was 36 at the time of her hip replacement surgery. She was happy with it at first, but then she heard about the recall.
No one looks forward to an additional surgery, and the fact is that every surgery carries significant patient safety risks. Even if the new operation is relatively free of problems, there's no guarantee that everything will go as well as it did the first time.
When the woman had her implant evaluated to determine whether she needed a second surgery, her doctors found such elevated levels of cobalt in her blood that she could be rendered infertile. She knew she had to have the DePuy ASR system replaced.
She also learned that her original surgeon had received over $600,000 in consulting fees from DePuy.
"I thought I was getting good advice. I researched the doctor. I picked him. I just don't know what I could've done differently," she testified. "It still blows me away that something that goes into the body doesn't get tested properly."
Unfortunately, the second surgery was not as successful as the first, leaving her with significant pain, a longer healing time and diminished mobility.
The Senate hearing, along with an April 14 hearing before the House Oversight & Government Reform Subcommittee on Health Care, are part of a broad effort on Capitol Hill to determine whether the FDA's approval process for medical devices are sufficient to protect patient safety. The hearings also seek to determine whether the FDA is doing enough to monitor the devices they approve after they get to market so that any necessary product recalls take place before so many people are affected.
Worldwide, more than 96,000 patients are affected by the recall of the DePuy ASR total hip replacement system.