Many of us in the legal world have been talking about the recent trend in recalled medical devices. Product liability and personal injury lawyers are especially concerned with the continually failing devices, and are concerned about the government process—one that is too rash and too lax on testing—that gets these devices onto the market.
MSNBC.com features an article on a recent device failure and its current investigation. In “Risky pelvic mesh highlights worries about FDA process,” Rita Rubin investigates a device called surgical mesh, intended to counter receding organs. Rubin specifically writes about Janet Holt, a woman who was affected by the uncomfortable organ slippage. When her bladder slipped out of place, her doctor recommended a surgical mesh device to prop up her insides. Unfortunately, this device only escaladed Ms. Holt's problems, increasing her pain, and leading to multiple surgeries in order to remove the device, which had slowly eroded into her vagina.
Although there is no evidence that pelvic mesh provides benefit, surgical mesh is not getting pulled off the market, despite the rising adverse events the products are causing: “From 2006 to 2007, the FDA received more than 1,000 reports of adverse events related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first revealed its safety concerns, to 2010, the agency received nearly 3,000 more.”
These failing devices are a part of a series of unfortunate events; multiple medical devices are failing and continuing to fail without FDA action. But all of these defective products and adverse events could be avoided. Rubin cites a study of 113 recalls from 2005 to 2009 found in the journal Archives of internal Medicine reports, “Of those [113 recalls], only 21 of the devices had been required to be tested on patients before receiving FDA approval.”
The lawyers at HM&M believe that this pattern of failing devices is due to a deeply rooted problem in government processes. We believe that with more comprehensive testing on medical devices, rather than a rush to the marketplace, defective products and the subsequent pain, discomfort, and funds applied to these defective products could be avoided.
Rubin reports on the FDA approval process, explaining that most medical devices do not have strict requirements to prove safety and effectiveness, like the requirements for prescription drugs do. After a growing number of concerns over surgical mesh, the FDA has issued warning of the product, and will decide whether or not the product should undergo comprehensive testing. As an attorney that specializes in negligence related cases, I do not believe that it should take a constant pattern of defective products and injured consumers to consider doing rigorous testing on a product.
Talking about potential cases of negligence can be a delicate dance. It can be difficult to determine whether the problem is with the doctors, or the FDA, or other government agencies. It is logical that doctors will accept and assume FDA standards as high enough standards, but we also wonder if we have to hold our professional community to higher standards. But part of the issue is with our technology -driven and industry-driven professional community. It is similar to a current issue with the recent recall of DePuy's metal-on-metal hip implants. We live in a society that values industry and advancement, and we are eager to try the latest and greatest of products, that is, assuming they are “improved” products. That being said, as consumers and as doctors, we should be able to assume that medical devices are approved and certified safe by comprehensive testing. We should be confident in the products that drive our industry. That is not so much to ask of a government agency whose very purpose is to set safety standards.
