The Wall Street Journal reported the FDA wants stricter safety requirements for surgical mesh kits to treat women’s pelvic problems, in a move that highlights the growing concerns over safety issues related to the devices.
The AP reported the FDA wants tougher rules for “trouble-prone implants.” The article noted that the agency wants plastic mesh used for repairing pelvic collapse be reclassified “as a ‘high-risk’ medical device,” instead of moderate risk, “following years of reports of pain, bleeding and infection among women who have received the implants.” The AP noted that if the change is adopted, it would require “manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.” More than 22,000 personal injury lawsuits have been filed against the leading maker of such meshes, Johnson & Johnson, the article added.
HealthDay quoted William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, from a press release, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.” The FDA “will also require manufacturers to submit pre-market approval applications to the FDA, so it can better evaluate a device’s safety and effectiveness beforehand,” the article noted.
The news was also covered by MedPage Today and Medscape.
From the new release of the American Association for Justice.
