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Transvaginal Mesh Products Show Up on eBay

Despite a voluntary recall earlier this year, C.R. Bard’s Avaulta Plus products are showing up for sale on eBay. The first transvaginal mesh implant was approved for use in 1996 – the ProteGen device. Although Boston Scientific later recalled the device, a loophole in FDA regulations called 510(k) allows similar devices to go through and … [Read more...]

US Drug Watchdog Fights Aggressively Against Transvaginal Mesh

Initially, transvaginal mesh was designed to help women suffering pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA promoted the devices as minimally-invasive, and specifically designed to work with women’s bodies. However, since 1999, when the first vaginal mesh device was recalled due to failures, women have been … [Read more...]

Plaintiff Claims Transvaginal Mesh Incompatible with Human Body

In the latest transvaginal mesh lawsuit, Debra Wooten, and her husband Ronnie, claim that Boston Scientific knew their transvaginal mesh device, the Tape Obtryx System Curved, was incompatible with human tissue, and chose to sell the device anyway. The plaintiffs are citing evidence from scientific studies showing that transvaginal mesh made from … [Read more...]

Tranvaginal Mesh (TVM) Could Lead to Autoimmune Disease Risks

Transvaginal Mesh (TVM) Lawsuit What are autoimmune diseases? Our immune system is a complex network of special cells and organs that defends the body from germs and other foreign invaders. At the core of the immune system is the ability to tell the difference between self and nonself: what's you, and what's foreign. The body can sometimes view … [Read more...]

Ethicon Ordered to Disclose Post-Market Transvaginal Mesh Studies to Court

The Honorable Carol E. Higbee has ordered Johnson & Johnson subsidiary Ethicon to produce all communications and correspondence between the transvaginal mesh manufacturer and the FDA regarding their regulation, Section 522. Section 522, under the Federal Food, Drug, and Cosmetic Act, is a combination of earlier laws that allows the FDA to … [Read more...]

Coloplast Transvaginal Mesh Lawsuits Consolidated into 6th MDL

The US Judicial Panel on Multidistrict Litigation has officially consolidated lawsuits against Coloplast’s transvaginal mesh devices into one multidistrict litigation, MDL 2387. The cases have been consolidated in the Southern District Court of West Virginia, under the honorable Judge Joseph R. Goodwin. Judge Goodwin manages 4 other MDLs against … [Read more...]

Win for Johnson & Johnson in Transvaginal Mesh Case

The blog Drug and Device Law reports that the case Smith v. Johnson & Johnson transvaginal mesh case has been decided – in the medical device manufacturer’s favor. According to the blog: There are two types of causation in a warning case. There's medical causation, meaning that the product must cause the injury. Then there's warning … [Read more...]

The 5 Current MDLs Against Transvaginal Mesh Manufacturers

While the US District Court of West Virginia decides if it will create a sixth multidistrict litigation (MDL) to collect a growing number of cases against transvaginal mesh and surgical mesh kit manufacturers, five MDLs are in place and currently hearing bellwether trials against medical device manufacturers. An overview of the current five is … [Read more...]

Litigation Judge Issues TVM Protective Order

After a status conference on July 26th, Litigation Judge Joseph R. Goodwin issues a TVM protective order to protect the companies involved in several of his MDL suits. Judge Goodwin is currently overseeing MDL 2327 (In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation), MDL 2325 (In re: American Medical Systems, Inc., Pelvic … [Read more...]

Three J&J Execs to Testify about Transvaginal Mesh Complications

In a July 19th ruling, the Hon. Carol Higbee, presiding judge over the consolidated litigation in Atlantic City, ordered that three Johnson & Johnson executives must testify in court regarding their transvaginal mesh products. The executives are new CEO Alex Gorsky, former J&J Vice Chairman Sheri McCoy, and Ethicon Franchise head Gary … [Read more...]

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