Articles Posted in Surgical Mesh Injury

Florida Surgical Mesh FailureAccording to court records, Johnson & Johnson (J&J) continued to sell a vaginal mesh implant after U.S. Food and Drug Administration (FDA) regulators told the company to stop marketing the device.

In a letter on August 24, 2007, the FDA told J&J to stop Gynecare Prolift sales while the agency assessed whether the device was “substantially equivalent” to similar products on the market.

Specifically, the FDA was concerned about a “potential high risk for organ perforation” and stated that J&J could no longer market its Gynecare Prolift until the company provided the agency with information on 16 specific issues concerning the device. “If you market this device without conforming to these requirements,” the letter said, “you will be in violation of the Federal Food, Drug and Cosmetic Act.”
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Johnson & Johnson sold a transvaginal mesh implant for three years before the U.S. Food and Drug Administration (FDA) provided approval.

According to Bloomberg, Johnson & Johnson’s Ethicon unit introduced the Gynecare Prolift device in March of 2005. At the time, the company touted it as an “innovative and effective surgical option” for weakened pelvic muscles. The FDA claims that the first it heard of the product was in 2007 when Johnson & Johnson named it as a predicate for another related product it was seeking approval for.

Johnson & Johnson states that it followed FDA protocol and claims it had the right to market the device without approval because it was so similar to an FDA approved device called Gynecare Gynamesh.

According to an FDA spokeswoman, the agency begs to differ with the corporate giant’s assertion, claiming that distribution began “without appropriate” clearance and that it should have filed a separate 510(K) for this product.
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It happened Tuesday afternoon, February 7. The Judicial Panel on Multidistrict Litigation (JPML) ruled that lawsuits filed in federal courts around the country against three synthetic vaginal mesh manufacturers could be transferred to be heard by one federal judge in West Virginia.

The cases were filed against American Medical Systems Inc. (MDL No. 2325), Boston Scientific Corp. (MDL 2326), and Ethicon, Inc. (MDL 2327).

The JPML ordered that 82 actions against American Medical Systems be transferred, 22 actions against Boston Scientific, and 36 cases against Ethicon be transferred to the U.S. District Court Judge who will hear the consolidated cases – Chief Judge Joseph R. Goodwin of the Southern District of West Virginia. There will be three different MDL’s consolidated against the three manufacturers to be heard by Judge Goodwin who is familiar with synthetic mesh injuries; he currently oversees the C.R. Bard Avaulta lawsuits.
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The C.R. Bard Company of New Jersey, is one of nine synthetic surgical mesh manufacturers whose products are used in women to treat stress urinary incontinence and pelvic organ prolapse. Avaulta is the best known Bard product, and despite the fact that the U.S. Food and Drug Administration (FDA) has received several thousand reports of complications from synthetic mesh, the Avaulta surgical mesh system is still on the market.

Of particular concern are the “arms” that are made of a form of plastic, a synthetic polypropylene mesh. Once implanted in the body, they grow into tissue and can adhere to organs, making them very difficult to remove. Complications may include erosion into surrounding tissue and organs, pain, nerve damage, migration of the mesh, and hardening of the plastic. The arms can be problematic to remove and, in some cases, surgeons will opt to leave the arms behind, sentencing the patient to a lifetime of pain and possibly disability. Other Bard products include Avaulta Plus, Avaulta Solo, and Avaulta Biosynthetic. Once the mesh is out, a woman may need reconstructive surgery to put damaged tissues back in place, such as reconstructing the vagina, the rectum, or the pelvic floor.
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With thousands of transvaginal mesh and bladder sling mesh lawsuits filed in state and federal courts around the country, it’s becoming increasingly clear that they cannot be tried separately. Lawsuits filed against the major manufacturers – C.R. Bard, Ethicon, American Medical Systems, and Boston Scientific – have in some cases been consolidated with other lawsuits against the same individual manufacturer.

On Thursday, January 26th, a federal panel of judges met to consider whether all of the cases should be consolidated before one federal judge. The U.S. Judicial Panel on Multidistrict Litigation (MDL) met in Miami to decide whether all of the cases, numbering in the thousands, should be consolidated before one judge in the Southern District of West Virginia. Judge Joseph R. Goodwin is already overseeing the C.R. Bard surgical mesh lawsuits and is therefore familiar with the issues, which include patient injury and a failure to inform by the manufacturers who may have understood that their products were defective.

The Judicial Panel delayed making any decision on the consolidation request.
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Lawsuits involving defective Avaulta vaginal mesh made by the C.R. Bard Company are getting one step closer to being heard. A judge presiding over the cases will hold a hearing this week to determine if eight cases will be ready for trial soon. These will be so-called bellwether cases with selected plaintiffs who represent some of the common problems women have suffered as a result of mesh used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Complications include: debilitating abdominal pain, mesh migration and shrinkage, perforation of organs, and repeat infections. Bard makes Avaulta, as well as PelviLace, PelviSoft, Uretex, Align, and Pelvicol.

Multidistrict litigation (MDL) consolidates hundreds of cases filed in courts around the country and puts them before one judge, who then becomes familiarized with the issues facing all of the plaintiffs. Multidistrict litigation saves plaintiffs the costs of individual trials in that it allows for a coordinated discovery process where the plaintiffs can share what is uncovered from the other side. The Judicial Panel on Multidistrict Litigation will hear arguments from both sides on January 26, including whether or not injuries in three different MDLs concerning Bard and other makers of mesh should be consolidated before Judge Goodwin in the U.S. District Court for the southern district of West Virginia.
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It may sound too devastating to be true, but some surgical mesh devices, including Bard Avaulta products, implanted in the vaginal walls of women to help alleviate pelvic organ prolapse (POP) and stress urinary incontinence (SUI) have caused serious health complications and physical injury.

The West Virginia Record reports that lawsuits are pending regarding surgical mesh devices causing organ injury in women. Requests were made to the U.S. Judicial Panel on Multi District Litigation last month to assign all 34 mesh complication cases, in addition to two from other districts, from Georgia to West Virginia. Attorneys making the request believe that the District Judge in West Virginia has become more acquainted with the issues at hand and the situation of the parties involved through pretrial handling of consolidated cases in his court.
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