The FDA ordered to stop transvaginal mesh sales and distribution in the United States. Researchers have been noting the danger of this device for years. Now, the government agency has finally realized that transvaginal mesh does not demonstrate safety or effectiveness like premarket applications. Companies must withdraw products within 10 days.
About Transvaginal Mesh
Transvaginal mesh patches are surgically implanted to combat the effects of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the pelvic muscles weaken. This causes the pelvic organs to descend from their normal place and bulge through the vaginal wall. The popularity of surgically implanting transvaginal mesh patches to hold organs in place has increased since the device’s 2001 approval, but unfortunately, researchers link the patch to painful and serious complications.
As reported by the FDA, significant problems resulting from the use of transvaginal mesh may include erosion of the vaginal tissue, infection, bleeding, pain, incontinence, pain during sexual intercourse (dyspareunia), organ perforation (puncturing) from surgical tools during mesh implantation, return of POP, neuro-muscular problems, or vaginal scarring.
FDA Stops Transvaginal Mesh Sales
In 2016, the FDA reclassified transvaginal mesh as class III or high risk. This means that makers of the device need to obtain FDA approval to continue selling products. Boston Scientific and Coloplast are the only companies that still sell and distribute meshes for vaginal use.
Boston Scientific is disappointed in the FDA’s decision and claim that their transvaginal mesh sales help 50% of all women in the US suffering from POP. However, thousands of injured consumers have filed lawsuits against device manufacturers. Other companies removed their devices last year and did not submit premarket approval applications. However, experts expect Boston Scientific to reapply. Yet, the company spent a large portion of the $929 million of its legal reserves in 2018 due to the mesh.
Free Consultation
If you experienced complications after receiving the transvaginal mesh patch, you may be eligible for compensation to ease the financial burdens associated with your injury, as well as offset your physical and emotional pain and suffering. Contact us today to set up a free consultation, during which we will listen to your story, answer any questions you may have and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.