FDA Halts Sale of Pelvic Mesh Tied to Women’s Injuries

FDA Halts Sale of Pelvic Mesh Tied to Women’s Injuries | Pintas & Mullins Law Firm

The U.S. Food and Drug Administration (FDA) has ordered two manufacturers to immediately stop selling a type of surgical mesh used to repair pelvic collapse in women.


The order comes on the heels of tens of thousands of lawsuits – including numerous cases brought by clients of Pintas & Mullins – charging that the mesh manufactured by Boston Scientific and Coloplast causes pain, injuries, and complications, including bleeding and infection.  


Women have also reported that the mesh, which is inserted through the vagina with a small incision, can shift out of place, puncturing internal organs or the abdomen wall. In such instances, multiple surgeries are required to remove or reposition the mesh.


Manufacturers Promoted Mesh to Speed Recovery Time

Starting in the 1990s, gynecologists began using the surgical mesh to treat pelvic collapse in women. About one in eight women in the U.S. undergo some form of surgery to treat pelvic collapse problems, which can cause the bladder or reproductive organs to slip out of place, causing pain, constipation, and urinary issues.


While the FDA approved use of the mesh specifically to treat pelvic collapse in 2002, the manufacturers promoted mesh as a way to speed patients’ recovery time compared to surgery with stitches.


The FDA said there is no need to have the mesh removed if patients are not having problems or symptoms. Women with the pelvic mesh, however, should continue to have regular checkups.


Pelvic mesh is the latest medical device for women to have safety issues long after receiving FDA approval. Last year, the FDA placed heavy restrictions on the birth control implant Essure, which was tied to allergic reactions, pain, and bleeding. Previously, the FDA warned against using a surgical tool for removing uterine fibroids because it could inadvertently spread cancer.


What to Do If You Suspect Hernia Mesh Complications

If you or a loved one are suffering from complications caused by the use of surgical mesh to treat pelvic collapse, please contact our experienced mesh attorneys. All consultations are free and you pay nothing unless we win. Call 800-794-0444 today.