The New York Times (Aug 22, 2011) reported that MoM implants made up for nearly one-third of the estimated 250,000 replacements performed each year (estimates run as high as 500,000 patients having received MoM hips) and 1,600 Zimmer Durom Cup complaints were filed with the FDA from 2007 to June 2011. That amount is likely much greater because doctors and patients are not required to file adverse event reports—only companies must comply with regulators.
News of the FDA rules regarding sales of MoM devices come as a shock to Zimmer hip recipients, some of whom feel like "crash test dummies": no testing of metal-on-metal devices was required; no clinical trials were conducted. In fact, MoM recipients were the clinical trial. Now, the FDA appears to be frantically backtracking. In May 2011, the agency requested medical device producers, including Zimmer, to study how often their devices failed and to examine the threat to patients.
Countless Zimmer hip patients experienced severe pain, many have undergone painful revision surgery and a number of hip implant patients have been diagnosed with tissue damage and blood poisoning due to metallic debris caused by these allegedly defective metal devices.
Needless to say, Zimmer's MoM sales—both the Durom Cup and Zimmer Natural—are likely down (the NYT reports that current use of all metal devices has plummeted to about 5 percent of the market) and surgeons are looking at alternative materials, i.e., other than metal that can cause increased levels of cobalt and chromium in the bloodstream and other adverse events. (So are manufacturers: Zimmer recently introduced a hip ceramic-on-ceramic implant. According to the company news release, the Maxera Cup is designed for younger and active patients.)
While the FDA's move is a step in the right direction, it's too late for many people.
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"I'm worse off now than before I had this Zimmer hip," says Sasha. "There is some improvement in pain relief when I rest, but I cannot do the activities that I did before, and I'm very unhappy with the result of the surgery." Sasha's complaints are similar to those of Mary and others: pain and reduced mobility. They can't walk with any endurance, they have trouble going down stairs and both are facing revision surgery.
One more thing Mary and Sasha have in common: they have both filed lawsuits against Zimmer.