Timeline
- 1996 – the first transvaginal mesh device, manufactured by Boston Scientific, is approved by the FDA
- 1997 – the first type of mesh for stress urinary incontinence repair are cleared for sale
- 1999 – Boston Scientific’s original mesh device is recalled over safety concerns
- 2002 – Johnson & Johnson’s Ethicon division releases the first surgical mesh product for pelvic organ prolapse (POP) repair
- 2011 – FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh used to treat POP be reclassified to a high-risk device
- 2012 – FDA issued post-market surveillance study orders to all manufacturers of urogynecologic surgical mesh products
- April 2014 – the FDA issued two proposed orders, which, if finalized, would reclassify surgical mesh as a high-risk device and require manufacturers to submit a premarket approval application
As of November 2014, seven major transvaginal mesh manufacturers are involved in a multidistrict litigation case in the U.S. District Court for the Southern District of West Virginia. Included are federal lawsuits filed against American Medical Systems, Ethicon, Boston Scientific, C.R. Bard, Coloplast, Cook Medical and Neomedic.
We Can Help
If you or a loved one had transvaginal mesh implantation and developed complications, you may be entitled to financial compensation. Recovery may include compensation for your medical bills, pain and suffering, lost wages, and loss of spousal consortium. Avram Blair & Associates P.C. is headquartered in Houston, Texas but handles transvaginal mesh cases nationwide. To find out if you have a claim, please call Avram Blair & Associates P.C. at 919-729-5152?? or contact us online for your free consultation.