After several months of review, the agency issued a public health notice about meshes used to treat pelvic organ prolapse and stress urinary incontinence due to a host of serious complications. At the same time, the FDA also updated new info for hernia patients.
For POP and SUI patients, the FDA received 1,106 reports between 2005 and 2008 from nine surgical mesh makers of complications, which are usually placed transvaginally using tools for minimally invasive placement. The most frequent problems included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion (look here).
For hernia patients, the FDA received 1,911 adverse events between 2004 and 2008, although the vast majority were related to two meshes that have already been recalled. In any event, the complications include adverse reactions to the mesh, adhesions (when intestinal loops adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels. Other problems can occur with or without the mesh, including infection, chronic pain and hernia recurrence.
"This has been a long time coming, but it is really just one step in the process. It is one thing to warn the general public, but the surgeons that implant these meshes need to understand that they could be doing great harm to someone. So, yes it is suffcient for now, until the investigation is over," says Jim Shull, a New Jersey resident who had a bad experience with a mesh and has lobbied FDA officials to take tougher steps. "But these products need to be made safer and if that can not be accomplished then they should be pulled from the market.
UPDATE: This is the list of manufacturers: American Medical Systems; Boston Scientific; CR Bard; Coloplast Manufacturing; Ethicon; Mentor; Sofradim; Tyco Healthcare; Proxy Biomedical, and Synovis Surgical Innovations. An FDA spokeswoman notes that eports have not been linked to a single brand or model of mesh and "that we believe this is a problem across the industry with all brands and manufacturers." Industrywide, there are about 20 manufacturers.