There have been tens of thousands of claims filed across the country against the manufacturers of the transvaginal mesh inserts. The lawsuits claim that complications could have been prevented had the manufacturers of these products properly researched the design or had they adequately warned the medical community or consumers of the risks involved.
The mesh inserts have been used for urogynecologic procedures and the repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Originally classified as a moderate-risk device by the Food and Drug Administration (FDA) in 2008, the device was bumped up to high-risk in 2016 by the FDA.
Complications of use include:
- Mesh erosion
- Pain during sex
- Urinary problems
- Organ perforation
Manufacturers such as Johnson & Johnson, and C.R. Bard have paid out millions of dollars in damages as juries continue to return favorable verdicts for plaintiffs in mesh cases. A number of companies chose to settle their cases prior to going to trial, and U.S. District Judge Joseph Goodwin is urging others to follow suit in order to cut their losses.
The use of mesh devices has not been recalled, and manufacturers continue to stand by their claims that the devices are safe and make for effective treatment of POP and SUI.
The FDA has stated that surgical repairs with mesh are not necessarily a more effective option to alternative treatment options, and they are warning consumers and the medical community of the risk of serious complications with use.