Endo Health Solutions says it will pay approximately $830 million (pretax) to resolve about 20,000 vaginal mesh complaints against it. The manufacturer acquired American Medical Systems Holding Inc., which makes the mesh implants, in 2011.
As of late February both companies were contending with about 22,000 defective medical device cases over the transvaginal products. Among the Endo devices included in the settlement are the Elevate, Apogee, and Perigee implants.
The implanting transvaginal mesh devices was initially seen as an enhanced alternative to tradition surgery to repair POP (pelvic organ prolapse.) However, the US Food and Drug Administration began to take notice a few years ago that there were a lot of women complaining that the mesh devices had caused them serious complications.
Mesh erosion was among the more common problems reported, while the list of health issues included severe pain, infection, incontinence, recurring prolapse, bleeding, urinary problems, scarring, dyspareunia (pain during sex), and organ perforation. According to analysis by the FDA, 10% of women experienced mesh erosion within a year, with more than half needing follow up surgery to get the mesh device taken out. Sometimes, this would require multiple procedures because the implant couldn’t be removed.
Recently, the FDA made two proposals to tackle the risks involving surgical mesh and its use in transvaginal repair to treat pelvic organ prolapse.
POP happens when the internal structures supporting the organs in the pelvic area become so stretched or weak that the organs end up descending from their placement and bulging into the vagina. This condition can be very uncomfortable for a woman, and it may disrupt her urinary, sexual, and defecatory functions, lower the quality of life, and even endanger her life.
If the FDA proposals are approved, the mesh used for transvaginal POP would be reclassified from a moderate-risk device (a class II) to a high-risk one, (a class III). Manufacturers would then be obligated to turn in a premarket approval application to assess effectiveness and safety. (The first mesh devices got fast-track approval from the government because they were considered similar to the mesh used in hernia procedures.)
Endo is just one of several manufacturers under fire for selling the transvaginal mesh devices, which are also used to treat Stress Urinary Incontinence (SUI). Recently, Johnson & Johnson was ordered to pay a 64-year-old woman $1.2 million for injuries she sustained from vaginal surgical mesh from its Ethicon line. The plaintiff said her pain was caused by the TVT-O mesh sling, which is a vaginal insert. She contends that the mesh device eroded in her body.
J & J is no longer selling these vaginal inserts, which are the subject of over 12,000 Ethicon mesh injury cases. Plaintiffs said that the inserts are defectively designed.
In Massachusetts, please contact our Boston vaginal mesh lawyers today to find out if you have grounds for a defective medical device lawsuit.
Endo Health Solutions settles lawsuits over vaginal mesh implants, Los Angeles Times, April 30, 2014
FDA comes down on pelvic mesh, AP/Journal Gazette, May 4, 2014
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, FDA, July 13, 2011
More Blog Posts:
Judge Rules $11 Million Topamax Birth Defect Award Will Stand, Drug Injury Lawyers Blog, May 9, 2014
Over 40,000 Transvaginal Mesh Injury Cases Filed Against Boston Scientific, Johnson & Johnson and Other Manufacturers, Drug Injury Lawyers Blog, February 14, 2014
Woman Awarded $3.35 million in Vaginal Mesh Case against Johnson & Johnson, Boston Injury Lawyer Blog, April 11, 2013