FDA addresses defective medical devices

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The U.S. Food and Drug Administration (FDA) proposed regulations restricting the sale of all-metal hip implants. Approximately 500,000 Americans have received these defective medical devices, many of which have failed prematurely.

The new regulation will require that hip implant manufacturers prove their devices are safe and effective before they continue marketing the existing implants and before the FDA would approve new designs. Presently, manufacturers only need to demonstrate that their implants are similar to implants already on the market and there are no requirements for conducting clinical studies before selling the devices.

The current FDA action is designed to close a loophole created in the 1976 federal law which first regulated medical devices. The proposed rules would be the first use of powers that Congress granted to FDA in 2012 to address medical devices that have been in “regulatory limbo” for many years. Agency officials said it will probably take at least a year for the proposed regulations to be finalized.

The rule change has been prompted by one of the biggest medical device failures on record. Only a few years ago, all-metal or metal-on-metal implants were used in one third of all joint replacement surgeries in the United States. Prior to that time, hip replacement implants were made of plastic and metal, with a life-time of approximately 15 years before they needed to be replaced. Although aggressively marketed by manufacturers as being superior to traditional hip implants, metal-on-metal hip implants have been found to fail at high rates soon after being implanted.

Thousands of people have been required to undergo additional surgery to replace the defective medical devices, being subjected to pain and additional expense. Not only are the metal-on-metal hip implants failing prematurely, many patients have experienced damaged tissues and bone as a result of metallic fragments being released into the body as the metal components of the implants rub against each other.

In addition to new regulations, the FDA expects to issue guidelines to doctors regarding monitoring of all-metal hip implant patients. The FDA will recommend that implant patients who have pain or other symptoms of device failure undergo testing for the purpose of detecting the presence and levels of metallic ions in their bodies.

Thousands of lawsuits have been filed against the manufacturers of the defective medical devices. The first trials involving the DePuy hip implants sold by Johnson & Johnson have begun. Some experts believe that it may cost Johnson & Johnson billions of dollars to resolve the lawsuits.

For more information, contact the Ohio defective medical device attorneys at Clark, Perdue & List.

Source: New York Times, “FDA Seeks to Tighten Regulation of All-Metal Hip Implants,” Barry Meier, January 16, 2013.