Texas Transvaginal Surgical Mesh Attorney Dr Shezad Malik provides this timely update for women would have suffered injuries and complications as a result of Surgical Mesh. Transvaginal mesh is an invasive surgical option for patients suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
What is Transvaginal Mesh Failure?
Many women with pelvic organ prolapse (POP), usually the uterus or bladder and stress urinary incontinence (SUI) undergo vaginally-placed surgical mesh. The mesh is inserted through small incisions made in the vaginal wall to support a prolapsing uterus or to support the urethra during SUI. Each mesh is surgically tailored, making it custom fit to each patient. Transvaginal mesh is made from natural material or from non-absorbable synthetic, polypropylene or polyester.
Transvaginal mesh failure occurs when the mesh starts to push its way through the vaginal wall. This side effect is known as “erosion.” The most common side effects from transvaginal mesh failure is erosion, pain, urinary problems, recurrence, organ perforation and vaginal scarring. When the mesh cannot be fully removed, it may lead to severe complications, including vaginal scarring, long-term pain, and pain during sexual intercourse.
J&J Ethicon Trial Just Ended
An Ethicon Gyncare surgical mesh defective product liability trial has just ended in New Jersey State Court. The jury heard that Johnson & Johnson’s Ethicon subsidiary knew about a high rate of vaginal mesh injury and failure problems with its Gynecare Prolift vaginal mesh before the product was introduced to the market. And according to the plaintiff, Ethicon sold the product without providing adequate warnings for consumers or the medical doctors.
Linda Gross, filed a lawsuit against Johnson & Johnson and she received an Ethicon Gynecare Prolift implant in July 2006. Gross developed severe complications that required 18 corrective surgeries. As part of the closing arguments in the trial lawsuit, the plaintiff attorneys showed the jury e-mails and re-played videotaped deposition testimony showing Ethicon’s repeated decisions to ignore reports of complications related to its Prolift vaginal mesh in a rush to get that mesh to market. This is the first of 1,800 vaginal mesh lawsuits against Ethicon pending in New Jersey Superior Court to go to trial.
Plaintiff allegations against J& J and Ethicon
Thousands of Ethicon Gyncare mesh lawsuits have been filed against Johnson & Johnson, complaining that the transvaginal surgical mesh used for treatment of pelvic organ prolapse and female stress urinary incontinence are defective and dangerous. There are about 1,800 lawsuits pending against Johnson & Johnson’s Ethicon subsidiary in New Jersey. There are about 2,000 lawsuits pending against Johnson & Johnson surgical vaginal mesh in the federal court system.
J&J Ethicon Surgical Mesh Recall
Johnson & Johnson has recalled and removed the Gynecare Prolift Pelvic Floor Repair System, Gynecare Prolift+M Pelvic Floor Repair System, Gynecare Prosima Pelvic Floor Repair System and Gynecare TVT Secure System from the market in June 2012.
FDA Warning on Failure of Transvaginal Mesh
The FDA recently updated its warning in July 2011, the FDA made clear that complications were not rare. Since its 2008 notification, the FDA received an additional 2,874 reports of injury, death and malfunction in transvaginal mesh procedures for POP and SUI repair. Seven deaths were linked to POP repairs. Three of them were directly associated with mesh placement failure. The other four deaths appeared to be due to other post-operative medical complications.
The July 2011 report also notified patients that transvaginal mesh procedures put them at greater risks of complications over traditional non-mesh procedures.
The FDA reports transvaginal mesh failure is associated with up to nine vaginal mesh manufacturers. The majority of complications have been reported among products made by Johnson & Johnson, Boston Scientific Corp., American Medical Systems, Cook, Covidien and CR Bard. Mesh materials are also manufactured by General Medical Devices and Caldera Medical.
Other Surgical Mesh Manufacturers Implicated
Many vaginal mesh lawsuits are also pending over other surgical mesh products manufactured by C.R. Bard, American Medical Systems (AMS), Boston Scientific and Coloplast Corp. There are a total of five different federal multidistrict litigations (MDLs) for each of the different manufacturers, which are all centralized in West Virginia.
The first federal vaginal mesh trial date is involving a Bard Avaulta mesh lawsuit. In July 2012, a California state court jury awarded $5.5 million in the first vaginal surgical mesh lawsuit to go to trial, involving problems with a Bard Avaulta Pelvic Mesh product.