Transvaginal mesh is a surgical device that has been implanted) in tens of thousands of women in North Carolina and across the country to repair pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). Its use has been a medical nightmare for many women.
Soon after the procedure became commonplace for POP and SUI, patients began to report such problems as protrusion of the mesh through the wall of the vagina (called “mesh erosion”), pain and infection. The U.S. Food and Drug Administration (FDA) has issued multiple warnings about complications following surgery involving transvaginal mesh, which is also referred to as “surgical mesh,” “pelvic mesh,” “pelvic mesh kits” or “gynecological mesh.”
Women who suffer complications form transvaginal mesh implantation must undergo additional surgery to have the faulty medical device removed. Many such patients and/or their families have sought compensation for the cost of the additional medical procedures as well as for their pain and suffering.
If you have experienced problems following a transvaginal mesh implantation procedure, you could be entitled to compensation for medical expenses, pain and suffering, emotional distress, lost wages, future expenses and more.
Contact the North Carolina defective transvaginal mesh lawyers at Hardison & Cochran now at (800) 434-8399 or reach us through our online form for a free case evaluation. You’ll hear from us within 24 hours, and your initial consultation will be free.
Defective Transvaginal Mesh Products and Injury
Transvaginal mesh implantation surgery received FDA approval for the treatment of stress urinary incontinence (SUI) in 1996 and for pelvic organ prolapse (POP) in 2002. Transvaginal mesh is permanently implanted to reinforce the weakened vaginal wall for POP repair or to support the urethra or bladder neck for the repair of SUI. The procedures caused problems from the start.
By 2008, the FDA had received more than 1,000 reports of “serious complications” associated with transvaginal placement of surgical mesh to treat POP and SUI. From 2008 to 2010, the FDA received 1,503 reports of complications after POP repairs and 1,371 complaints about surgical mesh products used in SUI repairs.
The FDA reviewed transvaginal mesh cases from 1996 to 2011 and concluded that use of a transvaginal mesh for surgical repair of pelvic organ prolapse, when successful, is no better than traditional surgical procedures for POP. The FDA also has stated that serious complications associated with surgical mesh for transvaginal repair of POP are “not rare.”
The most common complications to arise from implantation of transvaginal mesh devices include:
- Erosion, exposure, extrusion or protrusion of mesh through the wall of the vagina
- Organ perforation
- Urinary problems
- Pain, including pain during sexual intercourse (known as “dyspareunia”).
Additional complications reported to the FDA include neuro-muscular problems, vaginal scarring and/or shrinkage and recurrence of prolapse. Some affected patients also suffer from emotional problems attributable to their transvaginal mesh failure.
Additional surgery is often the only remedy for transvaginal mesh complications and injuries. Too often, it is impossible to completely remove the pelvic mesh from the patient’s body.
Transvaginal Mesh Manufacturers and Products under Scrutiny
Four multidistrict litigation cases (MDLs) being litigated in the U.S. District Court for the Southern District of West Virginia have consolidated hundreds of personal injury and wrongful death lawsuits from across the country. This legal action targets pelvic surgical mesh manufacturers C.R. Bard, Inc.; American Medical Systems, Inc.; Boston Scientific Corp.; and Johnson & Johnson (and its subsidiary, Ethicon, Inc.).
C.R. Bard, Inc., transvaginal mesh products (many designed and/or manufactured by a subsidiary of Covidien PLC) include Align, Avaulta BioSynthetic Support System, Avaulta Plus BioSynthetic Support System, Avaulta Solo Synthetic Support System, Pelvicol, Pelvilace, Pelvisoft, Pelvitex, Perfix Plug and Uretex.
American Medical Systems transvaginal mesh products include Apogee, BioArc, Elevate, IN-Fast, MiniArc, Monarc, Perigee and Sparc.
Boston Scientific transvaginal mesh products include Advantage (and Advantage Fit), Lynx, Obtryx, Pinnacle, Prefyx, Solyx and Uphold.
Johnson & Johnson / Ethicon, Inc. transvaginal mesh products include Gynemesh (and Gynemesh PS), Prolift (and Prolift M), Prosima, TVT, TVT Abbrevo, TVT Exact, TVT-O, TVT Retropubic System and TVT Secur.
Call North Carolina Defective Transvaginal Mesh Lawyer Today
If you have been harmed by the surgical implantation of a transvaginal mesh device to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP), call the experienced North Carolina defective transvaginal mesh lawyers at Hardison & Cochran toll free at (800) 434-8399 today or fill out our online contact form.
We represent victims of faulty medical products (including surgical mesh, pelvic mesh and pelvic mesh kits) in Raleigh, Cary, Wake County, Research Triangle Park, Durham and elsewhere in the Triangle, as well as in Fayetteville, Dunn, Southern Pines, Wilmington, Person County, Greensboro and the Triad, and throughout the state of North Carolina.