“Often the Only Safety ‘Testing’…Is in the Bodies of Unsuspecting Patients”
Posted on Wednesday, March 28th, 2012
And implants are in the news yet again – today, courtesy of a new investigation by Consumer Reports, which, according to their press release,
reveals that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these implants have never been tested for safety and manufacturers are usually required to do nothing more than file paperwork and pay a user fee before bringing their products to market. In fact, because of our broken regulatory system, often the only safety “testing” that occurs is in the bodies of unsuspecting patients.
We were grateful to receive an advance copy of the article, though the scenario it portrays is troubling, to say the least. Again, from CR‘s press release:
In 2011, a panel from the prestigious Institute of Medicine said the Food and Drug Administration (FDA) should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market. Instead, Congress is now debating legislation that would keep the present system virtually intact and ratify an agreement between the FDA and industry to get devices on the market even faster.
“Dangerous Devices” – available via ConsumerReports.com – focuses on four specific medical devices and their associated risks: surgical mesh, Lap-Bands, metal hips and cardiac devices.
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-Bands: 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 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.
The article also includes some tips for protecting yourself and encourages those who have had problems with implants – and other medical devices – to share their experience via CR‘s Safe Patient Project, where a series of searches brought up nothing on dental implants or even mercury amalgam. Maybe you have a story to share?