First Breast Implants came under scrutiny, then hip replacements, and now a shocking new research from Consumer Reports declares that many medical devices are not tested for safety at all.
Car manufacturers spend millions testing their vehicles for every imaginable accident, drinking water and food must meet certain standards, and even cell phones have had research as to the ramifications of their microwave radiation. So, it seems incredible that a device that is actually implanted inside the body, the ramifications of which are complicated and beyond the understanding of the average patient, can be brought to market by its manufacturer after a simple process of some paper work and a filing fee.
The report, which is available online at www.ConsumerReports.org accuses the regulatory system of being broken, leaving trusting patients and busy healthcare professionals at the mercy of the suppliers who appear to be happy using patient's bodies as their laboratory and sole testing procedure.
Nearly one in five Americans has some kind of medical implant, and that figure looks set to climb with more advanced prosthetics becoming available, along with the increasing affordability and popularity of cosmetic procedures. With that in mind, a panel from the Institute of Medicine recommended that the FDA totally revamp its regulating system for medical implants, saying that the current process provides no guarantee of patient safety, even after they have received an implant.
Unfortunately, Congress has taken the opposite approach and is currently in the process of approving legislation that would not only leave the present, yet inadequate system in place, but pave the way for manufacturers to bring devices to market even faster.
Availability of information, research and reviews into the devices available, combined with the fact that most patients will trust their physician to make the right choices for them, leave patients in the dark; the average consumer probably does more research and has more information about their car, laptop or sunglasses than they do about a potentially life threatening breast implant or hip replacement product that might cost tens of thousands of dollars.
The Consumer Reports investigation puts four of the most common devices in the cross hairs :
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.
Nancy Metcalf, senior program editor at Consumer Reports weighed in on the issue with valid points :
"While most of us have heard about the safety problems with metal-on-metal hips in the news, these devices are just one illustration of a much larger failure in our regulatory system ... Without major changes in the system, there really isn't much consumers can do to protect themselves, but we do urge people to ask their doctors about alternatives. Surgical mesh is a perfect illustration of a medical implant that is frequently unnecessary."
Metcalf makes some good recommendations to anyone thinking of undergoing an implant operation :
- Check the FDA website for information about devices. Warnings, recalls and complaints can be found at www.FDA.gov
- Look on the Internet for patient forums, people having trouble with an implant are likely to be vocal about their problems.
- Find out the name of the manufacturer, model name and number and serial number of the device. (incredibly some devices don't even have serial numbers.)
- Don't be afraid to cross-check with your doctor about his recommendation and ask about warning signs that indicate problems with your device.
- 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" 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 user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
While relying on government safeguards to protect the public might be one approach that works, market forces could also come into play. If consumers become more demanding about healthcare products and less trusting of regulation and healthcare professionals, and as more scandals hit the newswires, and as implants become more widely used, people may well begin to do their own research into what devices might suit them best; just as they do for computer processors or car tires. This would force medical device manufacturers to concentrate on building their brand name on trust, warranty and reliability, becoming household names, rather than operating behind a wall of pseudo professionalism, medical jargon and governmental lobbying. The choice of implant is clearly a very personal issue and it might be better approached as such.
Written by Rupert Shepherd