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Medical Devices Implanted in Patients Create Risk, Escape Testing

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

For patients who allow their doctors to implant medical devices in their bodies, it is a reasonable expectation that those devices have been thoroughly tested for safety and effectiveness. Unfortunately, however, the U.S. regulatory system too often leaves consumers of medical devices unprotected.

A recent Consumer Reports investigation highlights the dangers patients experience merely by using certain FDA-permitted medical devices. The magazine’s senior program editor cites the “failure” of the regulatory system; the report says that many medical device manufacturers introduce implants without safety testing. Patients in New York and across the country then become the unwitting testers.

Dangerous Side Effects, Injuries

Numerous medical devices have made headlines as their dangerous nature has become apparent. The DePuy metal artificial hip became available to the public without testing because of an FDA exception. It went on to cause tissue destruction and metal poisoning in some consumers, and in 2010 DePuy recalled all 93,000 units.

Lap bands, medical devices designed to promote weight loss in patients, were supported by one small study. In the study, most of the participants reported vomiting or nausea and one-fourth of them had the bands removed before the end of the study. Even so, more than 650,000 lap bands have been sold as of 2010.

Since 2009, cardiac devices have been at the root of a reported 29,000 deaths and injuries. The leads, or wires, that connect the devices to patients’ hearts have been significantly problematic.

Thousands of women who have been implanted with transvaginal surgical mesh have reported adverse events. Advocates continue to protest the use of the material, which was allowed into the market without being tested for safety.

A Permissive Regulatory System

Manufacturers of medical devices are allowed to “grandfather” in some of their products without testing that could show serious side effects or safety issues. When manufacturers fail to test for safety, they can miss the opportunity to stop dangerous products from reaching the market and harming vulnerable consumers.

Consumer Reports’ advocacy arm, Consumers’ Union, calls for stricter regulation and improved protection of patients. The group believes the practice of grandfathering devices should end; medical devices should be tested at least as thoroughly as new drugs; and there should be a system to track and notify patients of problems.

Patients whose lives depend on the safety of medical implants deserve the safest devices available.

Source: Market Watch, The Wall Street Journal, “Consumer Reports Investigation: Many Medical Implants Such as Surgical Mesh and Metal-on-Metal Hips Never Tested for Safety, Leaving Patients at Risk,” 3/28/12.

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