A North Carolina woman alleges that Ethicon’s Prolift vaginal mesh product, that she had implanted on October 21, 2008, caused serious complications. She is part of a new Ethicon vaginal mesh multidistrict litigation (MDL) from women and their families alleging that the company’s vaginal mesh products caused them serious injury. An MDL is created when cases filed by plaintiffs with similar complaints are consolidated and brought to trial in one court before one judge. This streamlines the process by lowering court costs, allowing a faster outcome, and is generally more efficient.
Vaginal Mesh Purpose
Similar to other women, the North Carolina plaintiff had been advised by her physician to use the vaginal mesh product to treat either her pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP can occur when the muscles and tissues of the pelvic floor can no longer support pelvic organs including the bowel, bladder or uterus. The organs may then prolapse, or drop from the normal position, into the vagina.
In a vaginal mesh procedure, the mesh is implanted and creates a hammock-like structure to support the drooping organs. In time, the body’s tissue grows around the mesh to stabilize it and to support the surrounding organs. The mesh procedure keeps the urethra and bladder neck shut during normal activities.
Women may suffer lower back pain, pelvic pressure, constipation, or urinary problems, and although not life-threatening, it can be negatively life-altering. SUI is a leakage caused by everyday activities such as exercise, coughing, sneezing, or laughing.
Surgical Mesh Background
Surgical mesh was first used by healthcare providers in the 1950s for hernia repair. The product gained the approval of the U.S. Food and Drug Administration (FDA) in 2006. Initially, surgical mesh has helped millions of women over the years treat pelvic organ prolapse and stress urinary incontinence.
In October 2008, the FDA began studying the device and listed the most common transvaginal mesh complications as: mesh erosion, infection, pain, urinary problems, recurrence of prolapse, and incontinence. Pelvic mesh was also associated with reports of bowel, bladder, and blood vessel perforation. In the two years following the FDA evaluation, approximately 3,000 vaginal mesh injury reports were submitted to the agency. The FDA then issued a public safety announcement stating that vaginal mesh complications were frequent and the debate began about reclassifying vaginal mesh as a high-risk device.
Transvaginal mesh plaintiffs and safety advocates have said that the mesh devices were approved through the 510(k) or “fast-track” FDA review. When products are cleared through this expedited process, manufacturers are not required to perform the generally rigorous clinical testing to show that the device is safe and effective. The 510(k) process only requires that the new product is “substantially equivalent” to a product previously FDA approved.
The FDA has since reclassified transvaginal mesh devices from “moderate-risk” to “high-risk,” meaning the products may no longer be approved through the 510(k) process.
National law firm Parker Waichman has extensive and successful experience in medical device litigation, including surgical mesh devices. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.
Recent Ethicon Lawsuit
The North Carolina plaintiff began experiencing painful complication soon after having the Ethicon vaginal mesh product implanted. The woman maintains that the complications she endured were not mentioned on the warning label of the product. Her complications included mesh erosion, infection, inflammation, scar tissue, organ perforation, organ prolapse, painful intercourse, urinary and fecal incontinence, and chronic nerve damage, according to her vaginal mesh lawsuit.
In essence, the plaintiff lost all control of her lower pelvic organs due to the allegedly defective design of the Ethicon vaginal mesh device. The damage was allegedly so extensive that the plaintiff had to undergo several seriously complex operations.
The plaintiff filed a lawsuit against Ethicon Inc. and parent company Johnson & Johnson for neglecting to warn her and her physicians about potential complications. The plaintiff claims that the company either knew or should have known about these issues, and failed to appropriately disclose the risk to the general public
The plaintiff alleges she used Prolift vaginal mesh product for its intended use and followed all medical instructions. She adds that she would not have used the Ethicon vaginal mesh product had she been aware of the risks.
Legal Information for Mesh Device Recipients
If you or someone you know has been injured by a medical device, such as Ethicon’s vaginal mesh device, you may be eligible for valuable compensation. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).