Tags: transvaginal mesh, surgical mesh, pelvic organ prolapse, stress urinary incontinence, incontinence, pop, mesh erosion
Transvaginal mesh implants, also known as slings, are a type of surgical mesh used in women to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh (or sling) is intended to act as a hammock, supporting the prolapsed organs in place. These transvaginal mesh implants have been implanted in millions of women. Approximately 200,000 inpatient surgical procedures for prolapse are performed annually in the U.S.
Have you been hurt by this defective product?
Transvaginal mesh implants have been linked to a high rate of serious complications. Women throughout the country have filed transvaginal or pelvic mesh lawsuits, seeking compensation for injuries including: erosion of the mesh; extrusion of mesh, which can require additional surgeries; painful sexual intercourse; perforation or puncture of the bladder, intestines and/or bowels; recurrence of POP; painful urination or difficulty urinating; vaginal bleeding; vaginal pain; vaginal scarring; shortening of the vagina, and chronic infections. In many cases, women require additional surgeries to remove the mesh or sling, and even more surgeries may be needed thereafter. Even following removal of the mesh, many women continue to experience vaginal pain and scarring, causing depression.
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. When POP occurs, the organs bulge or “prolapse” into the vagina, sometimes prolapsing past the vaginal opening. Other organs can be involved in POP including the bladder, the uterus, the rectum and the bowel.
Stress urinary incontinence (SUI) is when urine leaks during physical activity such as exercise, coughing, sneezing or even laughing. These conditions are usually a result of multiple pregnancies.
The FDA’s literature review found that erosion of the mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be depressing and debilitating for some women who thought this surgery would improve their quality of life rather than cause more pain and suffering. In some cases, even multiple surgical procedures will not resolve the problem. They are left with severe pelvic pain, painful sexual intercourse or those unable to engage in intercourse, at all. In some cases, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed from mesh erosion.
Pelvic mesh lawsuits have been filed on behalf of women in the U.S. against several manufacturers of the transvaginal mesh (TVM) and sling devices including:
American Medical Systems (Elevate, Perigee and Apogee)
- (Advantage Transvaginal Mid-Urethral Sling System
- Pinnacle Posterior Pelvic Floor Repair Kit
- Obtryx Transobturator Mid-Urethral Sling System
- Polyform Synthetic Mesh
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
- Uphold Vaginal Support System
C.R. Bard, Inc.
- Pelvisoft BioMesh
- Pelvicol Acellular Collagen Matrix
Johnson & Johnson/Ethicon
- Gynecare Prolift
- Gynecare Prolift+M
- Gynecare Prosima
- Gynecare TVT
On July 13, 2011, the FDA reported in a Safety Communication that it received 2,874 new complaints regarding transvaginal surgical mesh procedures from 1/08 through 12/10. Of these, 1,503 were associated with POP repairs and 1,371 with SUI repairs. Many of these women required additional surgeries. Some women still did not gain any improvement from the additional surgeries.
Congress has given the federal judicial system a mechanism to help manage complex civil lawsuits that are related to each other. In other words, when there are thousands of lawsuits involving related cases, the Judicial Panel on Multidistrict Litigation (JPML) has the authority to transfer related cases to one federal judge for “coordination and consolidated pre-trial discovery” in advance of trial. The panel is composed of seven federal judges based throughout the U.S., who have been appointed by the chief justice of the U.S. Supreme Court. After a district is chosen and a federal district judge is selected to manage the group of cases, the judge exercises full judicial powers over the case. The cases appear in the same court, however, each lawsuit remains separate and unique.
One unusual feature of Multi District Litigation for Transvaginal Mesh is that it is composed of four separate MDLs. Although all the cases in the MDL share the same complaints, there are four different defendants involved in the cases, which are the four manufacturers of the transvaginal mesh devices. Four smaller MDLs were created, one for each defendant: American Medical Systems (AMS), Boston Scientific, C.R. Bard, Inc., and Ethicon/Gynecare.
Most of the transvaginal mesh lawsuits allege that the manufacturers failed to warn of the risks and side effects. In a recent congressional report, it was found that transvaginal mesh devices went through the FDA’s 510(k) fast track approval process, even though the product these devices were based on, was recalled. The 510(k) process does not require clinical trials to be conducted on humans to prove that a product is safe if the product is based on another product, which is already on the market, even if that earlier product was recalled.
The first trial against transvaginal mesh manufacturer C.R. Bard, Inc. will begin on February 5, 2013. Consumers are seeking justice from the defective implants sold by Bard, which have caused such horrible pain and suffering to so many women. According to a report from Bloomberg News, the federal judge overseeing the Bard Avaulta transvaginal mesh MDL has scheduled the first bellwether trial for February 2013. Approximately 600 Bard Avaulta transvaginal mesh lawsuits are pending in the MDL cases.
This is a very unfortunate situation for thousands of women who sought medical help to correct an uncomfortable situation. The risks were never explained to these patients and most of them are worse off following the procedure, than they were before. These women are entitled to compensation for their pain and suffering, many of them are left with permanent impairment and their quality of life will never be the same.
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