Pharmaceutical

FDA didn’t test DePuy hip replacements before approving them

RALEIGH, NC—In a report about a hip-replacement patient suffering from the pain and failure of her DePuy artificial hips, ABC affiliate WTVD says that the controversial hip implants went to market without clinical trials.

New medical devices and prescription drugs typically must prove to the U.S. Food and Drug Administration that they are safe for consumer use by first undergoing clinical studies and medial reviews. So how did DePuy’s ASR (Articular Surface Replacement) Hip Resurfacing System and ASR XL Acetabular System win FDA approval without the requisite clinical trials?

WTVD unearthed a document showing that the FDA cleared the hip implants for market without testing by using a little-known regulation that allows a medical device to be approved if it’s similar to another device that has already been tested.

Traditionally, artificial hips consist of a metal ball inserted into a plastic-lined socket. However, DePuy’s artificial hips use metal-on-metal parts to reduce wear and the chances that the hips will need to be replaced again in the future.

The problem with DePuy’s metal-on-metal systems, however, is that the friction between the parts releases particles of toxic heavy metals cobalt and chromium into the tissue and bloodstream, causing metal poisoning and a spectrum of health problems ranging from mild to debilitating and even deadly.

With the DePuy hip implants in 93,000 patients worldwide, the company, a subsidiary of Johnson & Johnson, now potentially faces thousands of lawsuits from people whose health and quality of life has been ruined by their failed implants, proving yet again that proper clinical trials and approval procedures benefit the company as well as the consumer. Many orthopedic doctors believe that 100 percent of DePuy hip implants will need to be replaced before the end of the usual 35-year artifical-hip duration.

Studies have found that DePuy hip implants will fail 12 percent of the time within five years of hip-replacement surgery, meaning that 12,000 patients will need to have their hips replaced again in a “revision” surgery. Some of the less fortunate patients will not have enough bone mass left to sustain an additional surgery and may be permanently bound to a wheel chair and pain management therapies.