Endo International said it would shut down its Astora Women’s Health Division by the end of the month that has faced a number of lawsuits relating to defective transvaginal mesh implants. According to a news report in The Wall Street Journal, the division has been facing lawsuits involving vaginal mesh products that are intended to treat pelvic organ prolapse and urinary incontinence.
The drug company said it had increased its product liability accrual related to the cases by $834 million due to a higher-than- expected number of claims processed and additional settlements.
Feds to Tighten Regulations
Earlier this year, the U.S. Food and Drug Administration (FDA) said it would put these products under more scrutiny. The products will be reclassified by the agency as “high- risk” rather than moderate-risk medical devices. The FDA is also asking all manufacturers of mesh implants to submit data to support the safety and effectiveness of these devices before they are allowed on the market. Endo sold thousands of these implants.
Vaginal Mesh Side Effects
The most common side effects experienced by women who received these implants were erosion and organ perforation. Erosion refers to the process where the mesh embeds itself through a woman’s soft internal tissues. This could be extremely painful. Many women who experienced this problem also said they had severe pain during sexual intercourse and suffered severe urinary tract infections. A recent trial that evaluated about 3,700 patients found a 10 percent erosion rate when vaginal mesh is used.
Another common side effect is organ perforation. This refers to the penetration of the wall of a hollow organ in the body. The mesh, when it erodes and makes its way through internal tissues, eventually punctures organs such as the bladder, urethra, bowel or rectum. Based on reports made to the FDA, between 2008 and 2010, 5.8 percent of mesh surgeries resulted in organ perforation.
Compensation for Victims
We’ve represented women who have had to quit their jobs because they couldn’t tolerate the pain and had trouble even sitting down for long periods at work. Many relationships suffered because sexual intercourse became impossible. If you have suffered adverse effects as a result of defective vaginal mesh implants, contact an experienced product liability attorney who will fight for your rights and hold the medical device manufacturers accountable. You may be able to receive monetary compensation for your significant injuries, damages and losses.