Vaginal mesh complications have prompted thousands of lawsuits that continue to progress in federal multidistrict litigations currently underway in the U.S. District Court, Southern District of West Virginia. In March, the judge overseeing these proceedings issued an Order that designated four Avaulta mesh implant lawsuits for the first trials to be heard in the litigation established for the C.R. Bard pelvic mesh products. The March 7th Order indicated that the first Avaulta mesh trial will commence on June 11, 2013.
C.R. Bard Pelvic Mesh Lawsuits
C.R. Bard is the manufacturer of a number of vaginal mesh implants that are the subject of growing litigation. Vaginal mesh lawyers indicate that plaintiffs’ allegations involve vaginal mesh complications over the following C.R. Bard devices:
- Avaulta Plus Biosynthetic Support System
- Avaulta Solo Synthetic Support System
- Faslata Allograft
- Pelvicol Tissue
- PelviSoft Biomesh
- Pelvitex Polypropylene Mesh
Lawsuits brought over C.R. Bard’s Avaulta mesh products allege that the device maker knew, or should have known; about the dangers and risks associated with its mesh, yet continued to tout the devices as both safe and effective for the surgical treatment of pelvic organ prolapse (POP). C.R. Bard also neglected to sufficiently research the products and confirm that they offer long- and short-term efficacy, plaintiffs allege.
FDA Warnings over Vaginal Mesh Injuries
According to vaginal mesh lawyers, thousands of women began seeking compensation for alleged mesh injuries following a U.S. Food & Drug Administration (FDA) warning in 2008. At that time, the agency stated that it had received more than 1,000 reports of vaginal mesh complications associated with the use of pelvic mesh in transvaginal POP and stress urinary incontinence repair. About two years following this warning, the agency issued another alert in which it stated it received another 2,874 reports of complications associated with vaginal mesh products.
All of the vaginal mesh products named in surgical mesh lawsuits were approved under the FDA’s 510(k) clearance program. This program does not require human testing if a design is shown to be based on a previously approved device. Meanwhile, many of the vaginal mesh devices on the market referred to a now-recalled pelvic mesh product that was tied to serious complications. The FDA is now considering re-classifying vaginal mesh used to treat POP from medium- to high-risk devices so that the products would no longer be eligible for 510(k) approval.
The FDA has also asked vaginal mesh device makers, including C.R. Bard, to conduct post-market safety studies of their products so that the devices’ safety profiles may be better understood.
Mesh Implant Lawsuits Pending Throughout the United States
Vaginal mesh lawyer indicate that C.R. Bard is not the only device maker involved in litigation over pelvic mesh products. In fact, several other consolidated proceedings are underway in the Southern District of West Virginia involving American Medical Systems (AMS), Boston Scientific, and Johnson & Johnson’s Ethicon unit. Additional mesh implant lawsuits are also pending in consolidated litigations underway in New Jersey Superior Court, Atlantic County, for Ethicon and C.R. Bard products and, in March, the first United State’s trial involving an Ethicon mesh product concluded in the New Jersey litigation. In that case, the jury awarded more than $11 million to the plaintiff, including $7.76 million in punitive damages.
Business Specialty: A leader in litigating cases involving defective medical devices, dangerous drugs and consumer products, Bernstein Liebhard LLP is a New York-based law firm that has been exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993
Business Specialty: vaginal mesh recall, vaginal mesh lawsuit, vaginal mesh lawyer, vaginal mesh complications
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