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Guest: Medical Device Provision Puts Patients at Risk

If you had a heart condition and your surgeon wanted to implant a defibrillator in your body that was based on one with a dangerous defect, wouldn’t you want to know that the safety flaw had been fixed?

Of course you would.

Under current law, however, the Food and Drug Administration doesn’t have the power to require device makers in most cases to prove they’ve fixed safety flaws when they want to market a new device based on one that has been recalled by manufacturers.

Right now Congress is updating the law that governs medical devices in the United States, so there’s an opportunity to close this absurd loophole in our current oversight system.

If you’re like most people, you probably assume that all medical devices are required to undergo clinical testing to prove they are safe and effective before the FDA allows them on the market. Far too often, that’s not the case.

Surprisingly, more than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. While such testing may not be necessary for simple devices such as crutches or walkers, an alarming number of complex devices are implanted in patients’ bodies without this kind of review.

Instead, the FDA allows most devices to be sold based on whether they are “substantially equivalent” to devices that are already on the market. By law, the FDA can consider only whether the new device is similar to one already being sold and no evidence of clinical testing is required — even when the device it is based on has been recalled by manufacturers because of safety problems.

Believe it or not, if the manufacturer can prove the new device is substantially equivalent to the recalled device, then the FDA must clear it for sale even if the agency is aware that the device repeats the same design flaws.

The consequences can be disastrous for patients. Perhaps the most well-known example of this dangerous problem involves vaginal mesh implants used to treat urinary incontinence and weak pelvic organs in women. Surgeons implant the mesh in patients to strengthen tissue weakened by childbirth or age and to keep the women’s internal organs in place.

The first vaginal mesh implant was introduced by Boston Scientific, which received clearance from the FDA to market its ProtoGen bladder sling in 1997. The mesh sling was based on another device used for cardiovascular operations. But just two years later, the bladder sling was recalled after hundreds of women with the device reported experiencing serious complications, including debilitating pain and life-threatening infections.

Despite the recall, several vaginal mesh products have been cleared by the FDA since that time based on their substantial equivalence to the dangerous device that was recalled by its manufacturer. Not surprisingly, the problems women have experienced with vaginal mesh implants have not been unique to the recalled device and the FDA has received thousands of complaints from injured patients.

In 2011, the FDA warned doctors and patients that serious injuries associated with these implants are not uncommon. According to the FDA, the most frequent complications reported by patients include mesh erosion through the vagina, bleeding, infections, urinary problems and organ perforation. Many of these injuries require multiple surgeries to repair, and sometimes leave patients permanently disabled.

Manufacturers of the mesh implants insist they have improved the design even though their products have been cleared by the FDA based simply on their similarity to devices with a history of safety problems. However, device makers were not required to show they had fixed the design flaw in order to get the FDA’s green light.

Congress must reauthorize the medical device statute this year and industry lobbyists are pushing lawmakers to resist efforts to strengthen federal oversight, even though our current system is clearly broken and leaves too many patients at risk.

We need stricter safety testing for medical implants and other high-risk devices, and the FDA needs better tools to monitor devices once they are on the market. And it’s time to give the FDA the authority to require manufacturers to prove they’ve fixed safety flaws when they base new devices on ones that have been recalled.

Medical device makers insist this reform isn’t necessary, but thousands of women harmed by defective vaginal mesh implants prove otherwise. It’s time for Congress to put patient safety first and close this indefensible loophole.

James A. Guest is president and CEO of Consumer Reports.

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