The U.S. Food and Drug Administration (FDA) is stuck between a rock and a hard place.
On Tuesday, November 15, the Senate Committee on Health Education Labor and Pensions held a hearing on how the FDA’s approval of medical devices is working. There are two ways a medical device, such as surgical mesh or a hip implant, makes it to the market. The device either is submitted for approval through a premarket application (PMA), reserved for high risk devices, which requires a review of the clinical data to assure safety, or the fast-tracked 510(k) way that allows manufacturers to claim their device is similar to one already on the market and therefore does not need a redundant review by regulators.
In the real world, the FDA looks at very few devices through a PMA application. The majority of devices are approved through 510(k). This is why we have some defective medical devices allowed onto the marketplace that can actually injure or kill users, such as synthetic surgical mesh used in women to reinforce the pelvic region when organs prolapse or to treat incontinence.
Despite the thousands of injuries and deaths that have resulted, the majority of surgical mesh remains on the market. It never underwent PMA to assure safety for consumers.
In the opening statement by Sen. Mike Enzi, he voices concern about the disadvantages medical device manufacturers face with no mention of injured patients. He said manufacturers are concerned because the time to review a PMA has skyrocketed, roughly doubled between 2000 and 2008, and that means that manufacturers may take innovations overseas to seek approval. Enzi says the FDA has made it harder, not easier, to get devices to the market, arguing that the percentage of 510(k)s is found not to be “substantially equivalent” or withdrawns doubled between 2006 and 2011.
As a consumer, don’t you want the FDA to be regulating and rejecting some devices that are not substantially equivalent to another device?
U.S. Sen. Tom Harkin (D-IA) sounded more like the voice of the consumer when he said there is no virtue to getting these devices to market “if they don’t work or worse cause injury or death.”
People would be shocked if they understood the regulatory process, said Harkin. The 510(k) process requires a predicate device be named, but in some cases, such as the surgical mesh predicate, it was removed from the market because of safety concerns.
Boston Scientific’s ProteGen Sling was recalled on January 22, 1999. The reason stated in the FDA’s March 17, 1999 Enforcement Report was “Use of the ProteGen in female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
You would think that alarm would cause all devices that used it as a predicate to be reviewed. You’d be wrong. According to Sen. Harkin, “Certainly if a device turns out to be dangerous, if its withdrawn or recalled, its absurd to continue to use that device as a predicate for later products.” If you or a loved one has suffered any injuries or health problems due to a defective medical device, please call the Florida product liability lawyers of Farah & Farah at (800) 533-3555 for a no-cost consultation.
Source: http://help.senate.gov/newsroom/press/release/?id=3eae5a3a-bdf8-4744-ad1f-e1383725136d&groups=Ranking
