C.R. Bard Inc. is rolling in higher profits after postings its third quarter results, but the celebration may be short lived. The medical device company is facing dozens of lawsuits from patients who have asked to join a multi-district federal case against the company for allegedly selling defective and dangerous products, namely its Avaulta transvaginal mesh.
The multi-district litigation, consolidated from 21 individual lawsuits earlier this fall, includes complaints from women who received three different types of Avaulta mesh – Avaulta Biosynthetic, Avaulta Plus, and Avaulta Solo mesh.
Earlier this year, 29 other women who had previously filed lawsuits against the company for its other surgical mesh products asked to join the multi-district litigation. Those Bard mesh devices included Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and Align.
Transvaginal mesh is a type of surgical mesh used to repair pelvic floor disorders including pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is currently under review by the Food and Drug Administration (FDA) following numerous reports of injuries, many of which involved hospitalizations and surgeries.
The FDA reported that it received 15,03 adverse event reports associated with the mesh for POP repair between 2008 to 2010, five times as many as the agency received from 2005 to 2007. An FDA advisory panel fell short of banning the products, recommending instead to put stronger warnings on the devices. The agency is also considering reclassifying the device as high risk rather than moderate risk.
Lawsuits have also been filed against other transvaginal mesh makers including Johnson & Johnson and Endo Pharmaceuticals.
Source: Mass Device