The FDA recalled transvaginal mesh devices in September of 2011. The recall was for the Pinnacle Pelvic Floor Repair Kit, made by Boston Scientific Corporation. This kit is mainly utilized to reinforce tissue and fascial structure stabilization of the pelvic floor due to vaginal wall prolapse.
In October 2008, the FDA issued a public health notification advising medical providers as well as the public of health concerns when patients were implanted with the transvaginal mesh.
The Journal of Obstetrics and Gynecology Canada (JOGC) released a study in 2011, about pelvic mesh procedures. It stated, that Transvaginal Mesh devices used for prolapse repair should be thought as experimental and used only in trials until thorough and adequate safety evidence is obtained. Click here to read the full JOGC report discussing vaginal mesh.
On July 13, 2011, the FDA warned of transvaginal mesh complications and risks. The FDA recommended that health-care providers reconsider this method for treating PelvicOrgan Prolapse and Stress Urinary Incontinence.
Additional Transvaginal Mesh Information and Helpful Links
| Transvaginal Mesh Symptoms | TVM Medical Terminology |
|---|---|
| Hiring a Transvaginal Mesh Lawyer | Transvaginal Mesh Timeline |
| Transvaginal Mesh Home | Medical Devices Home |
For more information please contact Bernheim & Dolinsky, L.L.C. at 1-800-474-4089 or contact us online.
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