Medical device loophole leaves patients at risk
May 21, 2012
as Senate Prepares to Vote on FDA User Fee Act
WASHINGTON, D.C. – Consumers Union, the policy and advocacy arm of Consumer Reports, is calling attention to a dangerous medical device loophole that puts patients at risk in a full-page print ad in Politico today. The ad is running as the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.
The ad notes that the FDA does not have the power under current law to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems. Consumers Union has urged lawmakers to give the FDA the authority to require device makers to demonstrate that the safety flaws have been corrected in the new device.
“It’s time to close this absurd loophole and give the FDA the power it needs to protect patients,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “But so far, the politically powerful medical device lobby has blocked this common sense reform. Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients.”
The medical device industry claims that the FDA has the authority it needs to address this problem. However, Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, has confirmed in media interviews that the agency does not have the power it needs to prevent device makers from repeating safety flaws when new devices are cleared based on their similarity to ones recalled by manufacturers. While the Senate and House bills being considered this month include some important reforms, both bills are missing critical measures needed to protect patients. Neither bill closes this loophole.
Consumers Union’s ad directs readers to its Safe Patient Project web site, which debunks the medical device industry’s misleading arguments to Congress.
More than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. Instead, the FDA clears these devices through its fast track 510(k) process based on whether they are “substantially equivalent” to devices that are already on the market.
By law, the FDA can only consider 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 the manufacturer due to safety problems. If the manufacturer of the new device can prove it 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. The best 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 ProteGen bladder sling in 1997. But just two years later, the bladder sling was recalled by the company 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 recalled ProteGen bladder sling. 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 and 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.
Consumers Union’s ad also points out that the loophole would allow device makers to get new hip implants and defibrillators cleared for market based on similar models that have been recalled in recent years for safety reasons. Under current law, the FDA cannot require manufacturers to prove that the new device corrects the safety flaw of the recalled one.
A recent Consumer Reports poll showed overwhelming public opposition to this practice. It found that 71 percent of Americans believed that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled for safety reasons.
“Medical device makers have misled Congress that this reform isn’t necessary, but the evidence is clear that the FDA doesn’t have the power it needs to protect patients,” said McGiffert. “It’s time to use some common sense and close this indefensible loophole in the law.”
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