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tvm 9 articles

Bard settles transvaginal mesh lawsuits

C.R. Bard has agreed to settle nearly 100 lawsuits related to its transvaginal mesh (TVM) devices that were pending in U.S. District Court in West Virginia. Thousands of TVM cases are consolidated under U.S. District Judge Joseph R. Goodwin. In addition to Bard, cases are pending against other medical device manufacturers including Johnson & Johnson and Boston Scientific. In August 2013, Bard was hit with a $2.2 million jury verdict in the first transvaginal mesh lawsuit to go to trial in the consolidated multidistrict litigation (MDL). A jury found that the company’s Avaulta Plus Posterior BioSynthetic Support System TVM, used ... Read More

Transvaginal mesh injuries inspire ‘warriors’ fighting against ‘epidemic medical issue’

Transvaginal mesh injuries are so devastating that it isn’t only women who have suffered themselves who are speaking out against the devices, their manufacturers and the surgeons who are still performing these procedures. Family and friends are watching the aftermath of mesh and it is changing their perspectives and even some of their lives. Transvaginal mesh (TVM) is a type of surgical mesh used to repair pelvic organ prolapse (POP) and stress urinary incontinence. POP is when organs have dropped due to age, obesity or childbirth. Stress urinary incontinence is when a tiny bit of urine leaks during sneezing, coughing ... Read More

In a sea of transvaginal mesh lawsuits, FDA advisory panel reviews new pelvic surgical mesh product

Today, on Feb. 25, a U.S. Food and Drug Administration (FDA) advisory panel is meeting to discuss the premarket approval (PMA) of a surgical mesh device implanted in the female pelvis. No, the 30 months aren’t up yet for the manufacturers of currently under-fire transvaginal mesh (TVM) devices used to treat pelvic organ prolapse to submit their PMAs. When the FDA reclassified these devices as high-risk in January they also ordered the manufacturers to prove the safety and effectiveness of their devices through the PMA process. Today, however, it is a whole new surgical mesh device that is being reviewed. The TOPAS ... Read More

International researchers examine effectiveness, complications of transvaginal mesh for prolapse repair

Questions surrounding the safety and effectiveness of transvaginal mesh (TVM) used for the treatment of pelvic organ prolapse (POP) have risen to public consciousness lately following allegations that are coming out in courts about the devices causing injury, and recent action by the U.S. Food and Drug Administration (FDA) requiring premarket approval applications for the devices already on the market. Therefore, the timing is right for researchers to complete and publish useful information for women and their doctors to use in considering the treatment of POP. A new Cochrane systematic review published Feb. 8 specifically studies surgical repair of vaginal ... Read More

Johnson and Johnson agrees to compensate women injured by transvaginal mesh

According to Bloomberg Business, Johnson and Johnson has agreed to pay more than $120 million to resolve 2,000 to 3,000 suits in the transvaginal mesh (TVM) litigation against its Ethicon unit, its first big move to settle. Since 2011, when the the litigation in these cases began, some hundred thousand women have alleged they suffered organ damage and have been left in constant pain when surgical mesh implants designed to repair pelvic organ prolapse (POP) eroded in their bodies. Johnson and Johnson faces another 42,400 suits after these settlements, the largest number of suits in the multidistrict litigations (MDLs) against more ... Read More

Courts side with plaintiffs in $2 million transvaginal mesh verdict

There is more good news for plaintiffs in the multidistrict litigations (MDLs) against manufacturers of transvaginal mesh implants used to treat pelvic organ prolapse or stress urinary incontinence. On Jan. 14, 2016, C.R. Bard lost its appeal of a jury’s $2 million verdict that in August 2013 found the manufacturer liable for Donna Cisson’s injuries from defective vaginal mesh implants. Cisson’s case is the first to go to trial of the four bellwether cases in the West Virginia MDLs against C.R. Bard. There are also MDLs in West Virginia against Johnson and Johnson unit Ethicon Inc., Boston Scientific Corp., and ... Read More

How will the FDA ruling impact TVM litigation?

The U.S. Food and Drug Administration’s (FDA) two orders issued this week, reclassifying transvaginal mesh (TVM) as a high-risk device for treating Pelvic Organ Prolapse (POP) and ordering manufacturers to submit a rigorous premarket approval (PMA) application demonstrating safety and effectiveness within the next 30 months, are, according to the agency’s press announcement, based on thousands of reports of adverse events related to mesh used for urogynecological procedures in the past several years. “The FDA ruling confirms what we have been seeing from Plaintiffs in this litigation – transvaginal mesh used to treat pelvic organ prolapse is responsible for serious, chronic injuries for ... Read More

Woman awarded $1.2 million in transvaginal mesh injury lawsuit

A woman was awarded $1.2 million after a Texas jury found Johnson & Johnson liable for design defects in one of its transvaginal mesh devices that caused the plaintiff to suffer pelvic injuries. Linda Batiste, 64, claimed she suffered complications when her TVT-O bladder sling eroded inside her body. It was the first verdict against Johnson & Johnson involving its TVT-O device. Transvaginal mesh is a type of surgical mesh used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have prolapsed, or dropped, ... Read More

‘Inconsolable pain’ – vaginal mesh victim describes her injuries

“If I knew one-tenth of the information that was out there, published in the literature concerning [transvaginal] mesh complications and mesh reactions, I would have never consented to this surgery,” said Amy Gezon in a brief video documentation of her experience with transvaginal mesh, which her doctor implanted in her to correct a number of uncomfortable symptoms related to pelvic organ prolapse (POP). Before Ms. Gezon had the transvaginal mesh surgery, her surgeon told her she might experience some swelling afterward and that it was possible she might need a catheter for one or two days afterward. Motivated by the ... Read More