FDA requires more testing of transvaginal mesh products after safety concerns
Transvaginal mesh implants will undergo post-market safety studies after a spike in the number of complications linked to the devices.
The U.S. Food and Drug Administration (FDA) is requiring more than 30 manufacturers of transvaginal mesh devices, including Johnson & Johnson, Boston Scientific Corp. and C.R. Bard Inc., to perform post-market safety studies after a fivefold increase in the number of complications and injuries linked to these devices, including mesh erosion, pain and infection.
Transvaginal Surgical Mesh Complications
Contact us today if you suffer from any of the following transvaginal mesh complications:
- Urinary problems
- Bowel, bladder, and blood vessel perforation
- Erosion of the mesh into the bladder, intestines, uterus and/or vagina
- Vaginal scarring/shrinkage
- Painful intercourse
- Incontinence/urinary complications
- Recurrence of POP
- Corrective surgery
- Neuro-muscular problems
FDA Warning to Seek Alternative Treatment
In July 2011, the FDA issued a safety warning advising patients to seek alternative treatment options for POP and SUI. The safety communication came about after the agency linked transvaginal mesh to a much higher rate of serious complications than claimed by manufacturers.
The bottom line is that transvaginal surgical mesh has not been adequately tested as a safe and effective treatment for pelvic organ prolapse and stress urinary incontinence. That’s why the Ohio product defect lawyers at Elk & Elk support the FDA’s decision for additional testing.
We have been handling injury claims for 50 years. If you have been injured by a defective product, call 1-800-ELK-OHIO or contact us online. We have the experience, the resources and the dedication to handle your claim and fight for the compensation you deserve.
Call 1-800-ELK-OHIO for a free consultation if you have used transvaginal surgical mesh
If you suffered complications from transvaginal mesh implants, contact the Ohio injury lawyers at Elk & Elk for a free, no obligation case consultation. Call 1-800-ELK-OHIO or contact us online. Our product defect lawyers have 50 years of experience representing victims who were injured by defective medical devices and we can help you get the compensation you deserve.