Recently, Bloomberg News reported, “A Food and Drug Administration staff recommendation” said that transvaginally implanted surgical mesh “products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients,” and the mesh makers “may have to submit added safety data to regulators to keep their products on the market.”
In October 2008, the FDA issued a public health warning on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) and stress urinary incontinence (SUI). The FDA has received at least 3,800 reports of complications associated with surgical mesh devices used to repair POP and SUI. According to the FDA, reported complications include the mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, organ perforation and urinary problems. Some cases required additional surgery or hospitalization for treatment or to remove the mesh.
Now, following an updated analysis of the reports, the FDA has updated its warning to state “…that serious complications associated with surgical mesh for transvaginal repair of POP are not rare…it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” In 2010, there were about 75,000 POP repairs with surgical mesh using transvaginal procedures. If you would like more information or would like to discuss your rights, please contact our offices right away for a no charge, no obligation review.
