New Recommendations on Transvaginal Mesh
According to reports, an Food and Drug Administration (FDA) staff recommendation released September 1 urges the FDA to re-classify transvaginal mesh as “high risk.” If this change were to go into effect, manufacturers of transvaginal mesh products may be required to conduct post-market studies and comply with other federal measures to keep their products on the market. An FDA panel will meet September 8-9, 2011 to further review the safety of transvaginal mesh.
“High Risk” Devices
“Vaginal placement of surgical mesh for pelvic organ prolapse repair inherently introduces risks of complications that are unique to the mesh itself,” FDA Executive Summary.
The FDA classifies medical devices “based on the level of control necessary to assure the safety and effectiveness of the device.” Devices fall into one of three categories: Class I, Class II, or Class III. Currently, transvaginal mesh is a “Class II” device. Class II devices are eligible for approval under the 510K process, which is used to evaluate similar products that already have market approval. Some regulators are urging the FDA to change the classification of transvaginal mesh to “Class III.” Class III devices are considered “high risk” and require pre-market approval before being cleared by the FDA.
510K Approval Process
- Does not require devices to undergo a full-FDA approval process
- Involves comparing new products to similar devices that have already been approved
- The 510K process itself is now under review by the FDA
Transvaginal Mesh Injuries
Between 2005 and 2010, the FDA recieved more than 3,800 reports of complications/injuries associated with transvaginal mesh surgeries. Complications included:
- Erosion through the vagina (vaginal epithelium)
- Urinary problems
- 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.