Consumers Union, the policy and advocacy arm of Consumer Reports, has placed a full-page print ad in Washington, D.C.-based publication Politico, calling on Congress to close a loophole that allows dangerous devices to make it on the market without clinical testing.
The ad is running as the U.S. Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.
It specifically makes reference to two medical devices that have prompted thousands of lawsuits because they injured or even killed patients who received them: an allegedly defective transvaginal mesh implant manufactured by Johnson & Johnson, and an allegedly defective metal-on-metal hip implant manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics.
In a news release, Consumers Union officials refute an industry claim that the U.S. Food and Drug Administration already has the power it needs to keep dangerous devices off the market.
“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.”
Consumers Union takes issue with the FDA’s 510(k) process, which mandates approval of medical devices if they’re “substantially equivalent” to devices already on the market. By law, the FDA can only consider whether the new device is similar to one already approved 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.
According to the Consumers Union, more than 90 percent of medical devices are approved under that process.
“The consequences can be disastrous for patients,” the news release states.
As an example, it mentions the vaginal mesh implants used to treat urinary incontinence and weak pelvic organs in women. The first vaginal mesh implant was approved in 1997. Two years later, it 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 device. The agency has subsequently received thousands of complaints from injured patients.
The DePuy metal-on-metal hip implant was also approved under the 501(k) process, and later recalled in 2010 after nearly half of all recipients had to get a replacement within six years. Many also suffered metal toxic metal debris breaking off in their bodies.
You should consult with a doctor if you have any ongoing symptoms or health concerns from either device. If you have significant injuries, you should also consult with a lawyer familiar with the DePuy hip implant or transvaginal mesh case to discuss your legal rights.
See the news release here: http://safepatientproject.org/press_release/dangerous-medical-device-loophole-puts-patients-at-risk