According to a press release recently issued by Consumer Reports, an investigation conducted by the consumer watch dog organization reveals that some very common medical devices have never been tested to determine whether they are safe. This is an alarming finding given that nearly one in five adults in the U.S. has an implanted medical device.
The investigation and resulting report focused on four primary medical implant devices – surgical mesh, Lap-Bands, metal hips and cardiac devices. Here is what the investigation reveals about each:
Surgical mesh: No testing. Tens of thousands of women have been implanted with transvaginal mesh for prolapse repair and bladder support. Despite thousands of reports of adverse events, repeated alarms by women’s-health and consumer-health advocates, and multiple lawsuits, these products are still being sold and are still classified as “moderate risk” devices. How did the manufacturers get their products into the marketplace? They took advantage of a loophole in the law that allowed them to grandfather their products onto the market without any advance safety testing.
Lap-Band: Minimal testing. More than 650,000 have been sold worldwide, according to the 2010 annual report from its manufacturer, Allergan. Approval for Lap-Bands was based on a lone study of 299 people. Of those participants, 51 percent reported nausea, vomiting, or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure their bands removed before the end of the three-year study because of complications or failure to lose enough weight. “Imagine if a car had a recall rate that high,” says John Santa, M.D., M.P.H, director of the Consumer Reports Health Ratings Center. “Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden.”
Metal hips: Missed alarms. The artificial hip introduced in 2005 by DePuy, the orthopedic division of Johnson & Johnson, was cleared by the FDA without clinical testing. Instead it went to market based on “substantial equivalence” to earlier devices, though metal-on-metal hips such as this one had long been on the agency’s high-priority list for requiring advance clinical trials. DePuy recalled all 93,000 of these hips worldwide in 2010. Evidence suggests that metal-on-metal hips fail far more often than average and can cause metal poisoning and tissue destruction, leading to a litany of medical problems for the patient.
Cardiac devices: Significant problems. Implantable cardioverter-defibrillators are just one of three types of cardiac devices described in the Consumer Reports investigation that have had significant problems. Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to CR’s analysis of a federal database. The most troublesome aspect of the devices are the leads—wires that connect them to the heart.
Safety testing is the bailiwick of the Food and Drug Administration and it does not have a stellar track record to rely on when it comes to medical device testing. That said, the FDA website is a good place to start when it comes to researching medical devices if implantation has been recommended. The medical device "tab" on the FDA can be found here. You can find information concerning warnings, recalls and complaints that have been lodged concerning specific devices. You should also consult your physician about specific information on testing and safety issues and about device brand and model specific information so you can do some research on your own. Information is the best defense against a bad outcome so time spent on such investigation is time well spent.
Bret Hanna of Wrona DuBois in Utah, focuses exclusively on litigating plaintiffs’ medical malpractice and catastrophic personal injury cases. He has represented clients in state and federal courts, in mediations, and in administrative proceedings in Michigan and Utah since 1991.