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transvaginal mesh 233 articles

Beasley Allen fights for victims harmed by Johnson & Johnson products

Johnson & Johnson on its website claims that it is “caring for the world, one person at a time,” but recent verdicts against the multi-billion-dollar-earning multinational medical devices, pharmaceutical and consumer packaged goods manufacturer suggest the company is more interested in putting profits before patients. This week, a federal jury in Dallas awarded five plaintiffs a total of $467.6 million in a lawsuit that blamed Johnson & Johnson’s DePuy Orthopedics’ metal-on-metal hip implant for injuries including metal poisoning and revision surgeries. The verdict comes just weeks after a St. Louis jury awarded $72 million to the survivors of Jacqueline Fox, who sued ... Read More

Endo closes women’s health division in response to transvaginal mesh lawsuits

The Philadelphia Business Journal reports that Dublin-based Endo International is closing down its Astora Women’s Health division by the end of March. The division is headquartered in Eden Prairie, Minn. The company first tried to sell the Astora division, but, being unable to find a buyer, the decision was reached to shut down operations in part to “reduce the potential for product liability related to future mesh implants.” Endo, as well as the other manufacturers of transvaginal mesh (TVM) implants used to surgically treat such disorders as pelvic organ prolapse and stress incontinence, have been embroiled in massive multidistrict litigations ... 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

What kept FDA Warnings about Transvaginal Mesh from being heard?

FDA News Alert presented information from a study comparing the results of the two safety communications issued by the U.S. Food and Drug Administration (FDA) about transvaginal mesh that preceded the agency’s two final orders to manufacturers and the public. This January, a press release from the FDA officially reclassified surgical mesh used to repair pelvic organ prolapse (POP) transvaginally as a class III, high-risk device and it ordered manufacturers of devices already on the market to submit a vigorous a premarket approval application to support the safety and effectiveness of their device. The press release stated that the agency had issued safety communications ... Read More

Johnson and Johnson’s Mentor unit found liable in pelvic mesh case

Johnson and Johnson has been found liable in another pelvic mesh trial, with the verdict this time going against its unit Mentor Worldwide LLC ‘s pelvic mesh implant device known as the ObTape sling. In December the drug and device manufacturer lost in a case where plaintiff Patricia Hammons alleged subsidiary Ethicon’s Prolift transvaginal mesh implant eroded inside her body, leaving her unable to have sex. The jury found in favor of Hammonds and awarded her a total of $12.5 million in compensatory and punitive damages. Then, on Feb. 11, Ethicon’s transvaginal tape product, known as TVT, was the next of its devices to be ... Read More

Stock analysis deems Boston Scientific transvaginal mesh allegations ‘quite serious’

Stock market analysis site Trefis.com, which helps people to understand how recent news might impact a company’s stock, says that the “Latest Allegations (against Boston Scientific are) Quite Serious.” The analysis refers to ongoing litigation surrounding the company’s transvaginal mesh products, which have been linked to serious complications and injuries. The U.S. Food and Drug Administration (FDA) issued a warning earlier this year that these devices, which are used to treat pelvic organ prolapse, are now considered high-risk devices. The FDA is requiring all manufacturers to submit a premarket approval application proving safety and effectiveness of the product. A future ban, ... Read More

Johnson and Johnson, Ethicon found guilty in transvaginal mesh case; $13.5 million verdict

Yesterday a verdict was reached on the second case to go to trial in the Philadelphia mass tort program against transvaginal mesh manufacturers. A jury of eight women and four men found in favor of plaintiff Sharon Carlino, who alleged that Johnson and Johnson unit Ethicon’s transvaginal tape product, known as TVT, was negligently designed and her physician was not adequately warned of its risks. The company faces $10 million in punitive damages, $3.5 million in compensatory damages, and another $250,000 to Carlino’s husband for loss of consortium, totaling a $13.5 million verdict. Carlino received the TVT implant in 2005 to ... Read More

Lawyers seek resolution for transvaginal mesh cases, request move out of MDL

Manufacturers of transvaginal mesh used to treat pelvic organ prolapse and stress urinary incontinence are being sued by tens of thousands of women who claim defective mesh caused internal injuries and left many in constant pain. Since the U.S. Food and Drug Administration (FDA) reclassified transvaginal mesh as a high-risk device earlier this year, acknowledging more than 1,500 reports of problems, these numbers are only likely to increase. According to the FDA, reported complications from the transvaginal placement of the surgical mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse, and urinary and fecal ... Read More

Class action lawsuit claims TVM manufacturers used counterfeit materials

Manufacturers of transvaginal mesh (TVM) have been under intense scrutiny of late. The U.S. Food and Drug Administration (FDA) started out the new year with an order that all current TVM manufacturers have 30 months to submit premarket approval applications for their products, basically reapplying for FDA approval with a strict safety evaluation. There are tens of thousands of lawsuits against the seven manufacturers already underway, alleging the devices cause serious injuries including erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse, and urinary and fecal incontinence. Often women require surgery to remove the mesh. In some ... Read More

Jurors, health experts agree; pharmaceutical companies held accountable for transvaginal mesh injuries

Two weeks before the FDA reclassified transvaginal mesh as a high-risk device and issued orders that manufacturers submit a rigorous premarket approval application addressing safety concerns, on Dec. 22, 2015, Philadelphia jurors were reaching a verdict on the first case to be tried in Philadelphia’s mass tort program over pelvic mesh products. Their decision was right in line with the medical news that was soon to follow. Jurors awarded Indiana woman Patricia Hammond, 65, a total of $12.5 million in her lawsuit against Johnson and Johnson and its division, Ethicon. Of that amount, $5.5 million was awarded in compensation for damages ... Read More