Watching grass grow may be more exciting and productive than watching the Food and Drug Administration (FDA) take action on dangerous products. Recently, the FDA announced that it would recommend that transvaginal mesh used in pelvic organ prolapse repair be reclassified so that manufacturers would be required to show safety and efficacy BEFORE the device is put onto the market. Why did the FDA wait two years after its July, 2011 public safety announcement to make this decision? What REAL impact is this going to have on the American public – especially since most pelvic organ prolapse products have been pulled off the market in light of recent lawsuits? What answer does the FDA have for why it allowed these dangerous products to endanger women’s lives for nearly ten years by giving these manufactures a 510K “fast pass?” These and many other questions continue to float in the minds of injured victims while they, and the majority of the American public, desperately want to still believe that the FDA actually protects people from dangerous drugs and devices. Sometimes the truth hurts.
“Many transvaginal mesh devices can pose serious risks to women,” commented Robert Price, an attorney with the Levin, Papantonio who practices in the areas of bad drug and defective device litigation. “The unfortunate reality is that research has shown that the FDA has severely limited resources and is not in a position to truly protect the American public from all the potential dangers of a product; the FDA is, at most, a reviewer of data which is provided by a drug manufacturer,” he says.
In the case of transvaginal mesh products, the FDA allowed these devices to enter the market by “clearing” them through the 510(k) process. Through the 510(k) process, a device manufacturer does NOT have to show ANY safety or efficacy data to the FDA whatsoever. Public Citizen had petitioned the FDA in 2011 to stop the marketing of mesh products for pelvic organ prolapse, recall currently distributed devices, and reclassify them as Class III. This would have increased the regulatory oversight on the devices. The FDA is just now taking action.
Women have been reporting injuries that include pain and painful intercourse, organ perforation, infection, vaginal protrusion, extrusion, and exposure and more.
The FDA has let drugs that were killing people persist on the market before. Vioxx was allowed to be sold in the United States for years. The drug wasn’t recalled until 2004 when the company that produced it decided to recall it after recognizing that it more than doubled the risk of heart attack in consumers. The FDA has not acknowledged the risk and, according to its own website, “has not had an opportunity to review the data…”.
How much longer will the FDA stand by and let these devices continue to injure helpless people?