Several medical device makers are standing by their transvaginal mesh products despite FDA warnings, independent panel findings, and consumer reports of severe complications associated with the transvaginal placement of mesh products.
“Boston Scientific believes that mesh products are a valuable option for surgeons who treat women with pelvic floor disorders and stress urinary incontinence and that these products offer a safe and effective alternative to non-mesh treatment options,” official statement from Boston Scientific.
What the Device Makers are Saying
Boston Scientific- Keep transvaginal mesh in the class II status of medical devices.
- “We believe that the current 510(k) requirements for Class II devices are appropriate for surgical mesh devices intended to treat pelvic organ prolapse and stress urinary incontinence,” Boston Scientific.
Cook Medical- Consider the materials used in the devices before making rulings for all transvaginal mesh.
- “Important differences exist between non-absorbable synthetic mesh products and non-crosslinked biologic grafts,” Cook Medical.
Johnson & Johnson and Endo Pharmaceuticals Holdings- More safety studies and labeling changes could help.
- “[Transvaginal mesh is] not the optimal solution for everyone but it will be for some,” Johnson & Johnson’s Ethicon unit.
About Transvaginal Mesh
Transvaginal mesh and transvaginal mesh patches are woven mesh implants that stretch across the vaginal wall to support damaged tissue or prolapsed organs. The surgical mesh implant, which is made of woven mesh fibers, is used to treat both Pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI) in women.
In the last three years, the Food and Drug Administration has received thousands of reports of complications stemming from the transvaginal placement of surgical mesh. Complications include:
- Vaginal scarring
- Urinary problems
- Erosion through the vagina
- Recurrence of prolapse and/or incontinence
- Bowel, bladder, and blood vessel perforation during insertion
- Dyspareunia (pain during sexual intercourse)
- Narrowing of the vaginal wall (in POP repair)
- Decrease in patient quality of life due to discomfort and pain
Experienced Defective Medical Device Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side effects from the use of transvaginal mesh or transvaginal mesh patches, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.