Medical device implants receive little to no advance safety tests

According to a recent article published in Consumer Reports magazine, the U.S. government allows some medical device implants to be sold with little advanced safety testing or, in some cases, no testing at all. The report raised concerns about the lack of regulatory oversight of medical devices that are sold and implanted in patients throughout the United States.

It specifically criticized the safety testing involved in Allergan Inc.’s Lap-Band weight loss device, questioning its effectiveness. The product received government approval based on a limited clinical study of less than 300 patients, of which 25 percent had had the band removed before the end of the three-year study. Twenty-five percent of patients in the 1995 study cited complications from the surgery or failure to lose enough weight.

The product has been on the market since 1993, with more than 650,000 Lap-Bands sold worldwide. The company claims it controls 80 percent or more of the market. The product is surgically implanted and is designed to constrict the stomach to limit the amount of food that a patient can consume.

The report also expressed concerns about the risks associated with surgical mesh, metal hip implants and certain cardiac devices. Metal-on-metal hip implants and surgical wire mesh have been reported to have high failure rates resulting in numerous medical malpractice suits. The metal hip implants have been cited for damaging tissues and metal poisoning, while the surgical mesh could shift causing nerve damage in some cases.

Although the medical device manufacturers are complying with FDA regulations, it is those relaxed standards that are the problem. Safety testing and requirements need to be improved with congressional action. An Institute of Medicine report issued last year stated the approval process for medical devices is flawed, and urged the FDA to develop a new system to regulate approval of new implants that would better ensure patient safety.

The Consumer Reports National Research Center recently conducted a survey in which 17 percent of American adults claimed to have had a medical device implanted. If you have been harmed by a medical device or defective or recalled pharmaceutical product, consult with a personal injury attorney to learn your rights and the steps you can take to recover damages for your injuries.

Since 2009 nine patients have died in Southern California undergoing Lap-Band surgery at a clinic that markets the Allergan Inc. Lap-Band product, according to wrongful death lawsuits and other public records.

Source: Los Angeles Times, “Consumer Reports targets medical devices’ safety,” Chad Terhune, March 28, 2012.