Vaginal Mesh Lawsuits Allege Women Develop Complications Such As Bleeding, Infection, Chronic Pain From Unsafe Bladder Mesh Devices.
Two months after the U.S. Food and Drug Administration (FDA) tightened its regulations on transvaginal mesh products, Endo International PLC, announced its Astora Women’s Health unit would stop making mesh products to avoid more vaginal mesh lawsuits. Meanwhile, Johnson & Johnson has agreed to pay $120 million to settle 2,000 to 3,000 vaginal mesh lawsuit claims. Mesh manufacturers are defending themselves against lawsuits alleging their mesh products that treat pelvic organ prolapse and stress urinary incontinence are defectively designed and cause serious complications such as excessive bleeding, organ damage, vaginal scarring, and chronic pain.
Endo said it would close its Astora division at the end of March, according to a Wall Street Journal report. Endo’s American Medical Systems unit, now renamed Astora Women’s Health, is involved in a multidistrict litigation for mesh products in the U.S. District Court, Southern District of West Virginia. Endo’s unit is facing 11,100 vaginal mesh claims. The company said it has set aside $1.53 billion to cover legal costs. Johnson & Johnson’s Ethicon unit is included in the same federal mesh litigation. According to Bloomberg Business, Johnson & Johnson has set aside an undisclosed amount of money to settle more cases. The report noted that this is the first time Johnson & Johnson and its Ethicon unit have agreed to resolve a large number of mesh cases.
“While it appears that more vaginal mesh lawsuits may be settled, this does not stop the suffering of women who have been harmed by the products,” says Wright & Schulte LLC, which is representing alleged victims of transvaginal mesh complications in numerous vaginal mesh lawsuit claims. The Firm continues to offer free bladder mesh lawsuit reviews to women who believe they have been injured by these medical devices. Learn more by visiting yourlegalhelp.com or by calling 1-800-399-0795 to speak with one of the firms attorneys.
Transvaginal mesh is used to repair pelvic organ prolapse, which occurs when the bladder, vagina, uterus drop from their normal position. Mesh also treats stress urinary incontinence, or urine leakage, in women. Over the past several years, the FDA has received reports of the mesh devices causing complications such as chronic pain, organ perforation, erosion, and infection. In January, the FDA reclassified surgical mesh used to repair pelvic organ prolapse through the vagina from a moderate-risk device to a high-risk device. The change means mesh manufacturers are now required to submit a premarket application for their products, including ones currently being sold.The premarket approval process is more rigorous than the FDA’s 510(k) process under which mesh products were initially approved. The FDA’s order does not apply to surgical mesh for stress urinary incontinence or abdominal repair of pelvic organ prolapse.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm, FDA, January 4, 2016]
Over the past year, mesh manufacturers have been settling cases filed in the federal litigation in West Virginia. For instance, C.R. Bard announced it would settle 3,000 mesh lawsuits for $200 million, while Boston Scientific said it would settle over 2,000 bladder mesh complaints. Other manufacturers involved in the federal litigation include:
- In Re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326)
- In Re: Coloplast Corp., Pelvic Support System Products Liability Litigation (MDL No. 2387)
- In Re: Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
- In Re: Neomedic Pelvic Repair System Products Liability Litigation (MDL No. 2511)
About Wright & Schulte LLC: Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. free transvaginal mesh lawsuit case evaluations
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[wsj.com/articles/endo-international-to-close-astora-womens-health-due-to-lawsuit-concerns-1456752000, Wall Street Journal]
[bloomberg.com/news/articles/2016-01-27/j-j-said-to-pay-120-million-in-its-first-big-mesh-settlement, Bloomberg Business]