April 1, 2012 ~ The May issue of Consumer Reports (here) features an investigation into synthetic mesh and artificial hips – medical devices that escape rigorous testing to assure safety.
Tens of millions of Americans are living with medical devices and whether a defibrillator, artificial hip or surgical mesh, – 90 percent of those devices have escaped a Food and Drug Administration premarket review for safety and effectiveness.
Instead, the consumer organization reminds us that high-risk devices can be brought to market after the manufacturer pays roughly $4,000 and exchanges some paperwork before they receive permission to begin marketing.
Dr. Steven Nissan of the Cleveland Clinic authored a separate report finding more than 2,800 people died in 2006 due to faulty medical devices. “There is a consistent pattern of failure in medical devices, he tells CBS News.
The public makes an assumption what when their doctor advises them to a medical device that it is safe and has undergone rigorous testing. “That assumption isn’t always true,” Dr. Nissen says.
The Food and Drug Administration (FDA) tells Consumer Reports that current regulations have “served American patients well” despite all of the injuries and that “as a responsible guardian of public health, the FDA believes it’s a challenge to eliminate a program without having a better alternative.”
At the present time, the FDA and industry are debating a system that would allow medical devices to make it to market even faster.
Janet Holt – Holt had a profile done on MDND. In 2007 the Texas woman had a hysterectomy and synthetic mesh implanted which left her in debilitating pain. Eight surgeries later, she has been left with nerve damage. She is suing the mesh manufacturer claiming “it has totally ruined my life.”
Despite that, the FDA still classifies surgical mesh as a “moderate risk” device.
History of Risk Devices
Consumer Reports reminds us that before1976, any medical device maker could sell a product at will. But that year the FDA began classifying medical devices into three categories with Class I including latex gloves and bandages, Class II a “moderate risk” (synthetic mesh), and Class III the most risky of devices.
Synthetic surgical mesh is routinely cleared on the market as long as it is claimed to be the substantial equivalent to a device already on the market. Mesh kits were cleared claiming a similarity to hernia mesh which was sold in the 1950s. But mesh implant transvaginally goes through a different part of the body, a clean contaminated field when it passes through the vagina.
In 2011 the Institute of Medicine encouraged the FDA to overhaul its medical device regulatory system because of the thousands of patient injuries.
Consumer Reports says, “Most medical implant have never been tested for safety.”
How to fix the system
Consumers Union, the advocacy arm of Consumer Reports, agrees with the Institute of Medicine that the current system of medical-device regulation doesn’t protect patients from harm. Consumers Union recommends that the FDA:
- Require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.
- End the practice of “grandfathering” high-risk new implants and life-sustaining devices.
- Create a “unique identifier system,” or IDs for implants, so that patients can be quickly notified about recalls and safety problems.
- Create national registries so that problems can be spotted quickly and patients notified.
- Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
Have you had a problem? Tell us about it now. If you’ve had a problem with an implant or a medical device, please tell Consumer Reports about your experience. Your information is kept confidential (unless you indicate otherwise) and your story helps us monitor medical problems, research future articles, and push for reform.
To help, go to SafePatientProject.org and click on “Share Your Story” or click on “Act Now” to help us work for change.
Consumer Reports May Issue
Suffering in Silence : Janet Holt
Institute of Medicine Report July 2011
IOM briefing -Video on 510(k)