The invasive medical devices known as transvaginal mesh, metal-on-metal hip implants and the Lap-Band gastric band have gotten quite a bit of attention lately, most of it bad. We’ve written about all of these products, and they remain prominent poster children for poor regulatory oversight thanks to a recent investigation by Consumer Reports.
It concerned the millions of Americans who have had medical devices implanted without the products’ safety having been fully vetted. “Often,” according to Consumer Reports, “the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients.”
The three devices mentioned above are hardly alone. The investigation looked at a variety of devices, including artificial joints and heart defibrillators subject to the FDA’s 510(k) approval process. That’s shorthand for the process by which medical devices are able to be marketed with so-called “fast-track” approval because they are substantially equivalent to another product already on the market. Initially, the fast-track option was intended for more basic medical equipment, such as bandages, that didn’t require clinical trials to determine efficacy, safety and side effects.
Now, in many cases, manufacturers of higher tech, more invasive devices need only fill out forms and pay $4,000 to move their product to market. Most patients are unaware that many of the devices have never been tested. Is it any surprise that problems have occurred, lawsuits filed and recalls implemented?
Not only is oversight lacking for “substantially equivalent” devices, Consumer Reports contends that safety studies for the smaller number of high-risk products for which they are required are small and less rigorous than those required for prescription drugs.
The U.S. Government Accountability Office (GAO) and, as we reported, the Institute of Medicine (IOM) have called for a 501(k) re-do, but legislation that essentially keeps the cozy relationship between the FDA and manufacturers intact is brewing.
Consumer Reports identified three areas of primary concern:
- Medical devices often aren’t tested before they come on the market.
- There’s no systematic way for the government, researchers or patients to spot or learn about problems with devices.
- Without major changes in the system, there’s not much that patients can do to protect themselves.
Exemplary of the first concern is transvaginal mesh. It’s intended to treat prolapsed pelvic organs-those that have dropped out of normal position. The first such products came on the market in the early 2000s and were marketed to doctors as an easier way to do a surgery that had required special additional training.
“Despite thousands of reports of adverse events,” Consumer Reports said, “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.”
Mesh manufacturers took advantage of the “substantially equivalent” law. They claimed the female pelvic mesh was similar to an earlier mesh used to repair abdominal hernias that was sold in the 1950s. Never mind that those products were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.
In January, the FDA ordered 33 companies to conduct the first-ever post-market safety studies of transvaginal mesh. The agency is thinking of reclassifying those mesh kits to the highest-risk, Class III, which would require clinical tests before market approval. That decision can take years.
The second area of concern helped Lap-Band notch its dismal track record. Its initial approval was based on a single study involving 299 people, half of whom reported nausea, vomiting or both. One in 4 had their bands removed before the end of the three-year study because of complications or failure to lose enough weight. What are the chances people would choose this procedure if they knew half of its other patients had to have it removed?
The Lap-Band clinical trial was fairly typical of such pre-marketing studies. The journal Archives of Internal Medicine looked at 123 studies done on high-risk cardiovascular devices that received FDA approval between 2000 and 2007. Only about 1 in 4 met the gold standard of being randomized clinical trials, according to the report. Per its manufacturer’s 2010 annual report, 650,000 had been sold.
Lack of access to information harmed an orthopedic surgeon, someone you’d think would be best positioned to know about the problems with the DePuy ASR XL metal hip implant. But he, too, became a victim of its deficiencies.
The FDA had cleared the ASR XL without clinical testing based on “substantial equivalence” to earlier devices, even though such metal-on-metal hips had been deemed high priority for requiring advance clinical trials. The ASR XL was introduced in 2005. In 2006 the surgeon’s arthritis prompted him to have it implanted.
A year later, pain was constant and the chromium and cobalt levels in his blood were elevated. His sleep was disturbed, he had mood swings, anxiety, hearing loss and visual problems. He questioned DePuy’s engineers, who denied having heard any such reports. He continued to research the subject and began uncovering evidence that metal debris from joint implants can be poisonous.
Other countries keep records of every joint implant, and how it performs. Adverse events from DePuy’s metal implant had been appearing by the time the orthopedic surgeon began researching. The United States has no such public registry.
The surgeon underwent removal and replacement with a ceramic and plastic model. His symptoms have improved markedly.
The FDA has a voluntary system for doctors, manufacturers and patients to report problems with medical devices. Called MedWatch, it’s where only a fraction of device problems ever get reported. Consumer Reports says from 2009 through 2011, the agency received 20,518 reports of injuries from metal-on-metal total hip replacements. Of those, 15,137 concerned the now recalled DePuy hip. Many of the remaining complaints concerned several other brands and models that are still on the market in the U.S.
DePuy recalled all 93,000 ASR XL hips worldwide in 2010.
Consumers Union, the advocacy arm of Consumer Reports, says that the FDA should:
- 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.
Consumer Reports sponsors a “Share Your Story” link on its Safe Patient Project site whose intention is to lobby for legislative change of flaccid regulations.
To protect yourself now from deficient oversight or the damage done by defective devices:
Consider alternatives. Ask your doctor what will happen if you don’t get the implant. Many women who received transvaginal mesh for prolapse repair, for example, probably never even needed surgery. And there are nonmesh alternatives.
Research the device. The FDA website offers a wealth of information about device safety warnings, complaints and recalls. A simple Google search can yield important information, provided you’re certain of a site’s authenticity and authority. If the results include a lot of law firms looking for clients injured by a given device, Consumer Reports advises asking your doctor some hard questions.
Search also for patient forums about particular products. That information isn’t scientifically validated, but you’ll get a sense of whether patients are reporting trouble with the device.
Write down what you got. Ask your doctor for the brand name, model and serial number of your device. If you hear about a warning or safety recall, from the FDA or elsewhere, you’ll know whether yours is one of the problem models.
If you learn about problems with your device, contact your doctor and ask what warning signs to watch for. Search the FDA website to find out if it’s safe to keep the device in your body.
Not all problematic devices must be removed. If yours isn’t causing problems, it’s likely you needn’t do anything but remain attuned to its performance.