The Securities and Exchange Commission estimates that 47,000 women have had transvaginal mesh implanted and that currently there are 600 lawsuits as a result, pending in the United States. While transvaginal mesh is meant to treat weakened pelvis areas, it can result in pain, infection, bleeding, sexual intercourse difficulties, urinary problems, scarring and organ perforation.
The rise in reports of transvaginal mesh injuries comes after the rise of transvaginal mesh operations: doctors performed more than 100,000 operations for pelvis organ prolapse and stress urinary incontinence, and about 75% were performed transvaginally. The FDA has estimated that between 30 to 50% of women will experience pelvic organ prolapse (POP) during their lifetime.
Warnings from the FDA & Doctors
The FDA has warned that, "Serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. Furthermore, it is not clear that transvaginal pelvic organ prolapse repair with mesh is more effective than traditional non-mesh repair in all patients and it may expose patients to greater risk." The FDA has also articulated that other options might expose women to less risk than a transvaginal mesh operation.
In the words of one doctor, "I strongly support Public Citizen's petition to the Food and Drug Administration to ban the marketing of all currently available non-absorbable surgical mesh products designed and labeled for transvaginal repair of pelvic organ prolapse and to order all manufacturers to recall such products. I am fully aware of the complications, which are too common, the management of complications, and their potentially lifelong ramifications. I have come to the conclusion that using mesh for transvaginal repair carries far more risk without any added benefit when compared with the standard surgical approaches without using mesh."
Since 1999, complications from transvaginal mesh have been reported. That year, Boston Scientific voluntarily recalled 20,000 implants.
Injuries from Vaginal Mesh
From January 2008 to December 2010, the FDA received 2,874 reports of complications associated with transvaginal mesh. In this time period, there were also seven reported deaths associated with POP (pelvis organ prolapse) repairs. Within three years, the U.S. Food and Drug Administration has issued two notifications to doctors and patients warning about the problems with surgical mesh products.
Surgical mesh is composed of material that has been compared to Rubbermaid storage containers. Many of these plastic devices were originally designed for hernia repair, not pelvic organ prolapse. When the mesh erodes or contracts over time, serious problems can result, such as:
- Vaginal pain
- Vaginal scarring and shortening
- Dyspareunia- painful sexual intercourse
- Feeling a lump in the vaginal opening
- Perforation or puncture of the bladder, intestines and bowels or blood vessels
- Recurrent Pelvis Organ Prolapse
- Urinary problems
- Vaginal bleeding (hemorrhage)
- Vaginal chronic drainage, discharge and infections
Let Zinda Law Group represent you!
When these side effects occur, a patient can sue for damages- such as medical expenses, emotional distress, loss of consortium, loss of quality of life and lost wages. Surgical mesh is designed to reinforce weakened tissue- when it creates more problems than it solves, the results can be devastating. Hundreds of women have filed transvaginal mesh lawsuits from manufacturers such as Johnson & Johnson and C.R. Bard, and with the aid of a qualified personal injury lawyer, you can too!
In some severe cases, the mesh must be surgically removed. In other cases, the mesh cannot be removed and women are left to permanently suffer. If you need help filing a lawsuit against American Medical Systems, C.R. Bard, Boston Scientific, Johnson & Johnson or another transvaginal mesh manufacturer, Zinda Law Group can help you! Don't fight this battle alone. When your life has been so adversely affected, you need quality legal assistance on your side to help you achieve the justice and recompense you deserve. Contact us today!