The Federal Drug Administration (FDA) is currently investigating Boston Scientific due to allegations that the manufacturer has used counterfeit raw material in their surgical mesh products.
The mesh implants are used to treat urinary incontinence and a number of other organ problems in women. Thousands of women have already filed lawsuits claiming that the mesh has caused serious injuries.
Though the FDA has said that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit material, the agency has stated that current data does not suggest that counterfeit materials were a contributing factor to adverse effects. The FDA has not currently recommended that implants be removed, but believes “that health care professionals and their patients should be aware of this investigation.”
Officials have said that Boston Scientific will conduct new tests over the course of the next few months to further test the safety and effectiveness of their medical mesh.
Boston Scientific has rejected allegations, claiming that “counterfeit” or “adulterated” materials are not used in their devices, and that they are committed to patient safety.
Serious Complications Associated with Vaginal Mesh
Thousands of women who have used vaginal mesh devices for treatment of POP, SUI, or other conditions caused by the movement of pelvic organs have reported adverse effects and serious complications. In some cases, adverse effects did not subside after removal of the device and are considered to be permanent.
The most commonly reported complications include:
- Extrusion and erosion of the mesh
- Recurrent infections
- Pain during intercourse
There are currently thousands more claims filed against other manufacturers of transvaginal mesh devices, including Cook Medical, C.R. Bard, Johnson & Johnson, and American Medical Systems.