On May 26, 2017, health care giant Johnson & Johnson lost its fourth surgical mesh lawsuit when a Philadelphia jury returned a verdict of $2.16 million against Johnson & Johnson and its Ethicon Women’s Health and Urology division.
Observers see this fourth loss in four trials as a trend in lawsuits over alleged surgical mesh complications.
Parker Waichman notes that in the U.S., about 80,000 lawsuits have been filed against the manufacturers of transvaginal mesh including Boston Scientific, C.R. Bard, Ethicon, Cook Medical, Coloplast, and American Medical Systems
Mesh Complications
Surgical mesh—also pelvic mesh or transvaginal mesh—is used in surgery to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These conditions can occur when the pelvic structures that support the woman’s uterus, bladder and intestines weaken due to childbirth, surgery, or aging. The organs drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems. Before transvaginal mesh became available, surgery for POP and SUI involved creating support for the organs using the woman’s own tissues.
Women who have had transvaginal mesh devices implanted report serious, sometimes permanent, injuries and side effects following the implant. Common side effects include:
- mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- pain
- infection
- bleeding
- pain during sexual intercourse
- organ perforation
- urinary problems
Many women have undergone additional surgery to attempt to remove the mesh and to repair organ damage. These surgeries, however, are often not successful. Some women have been caught in a cycle of repeated episodes of mesh erosion and surgery to remove protruding mesh.
The lawsuit was brought in 2013 by a woman from Pen Argyl, Pennsylvania. The suit was part of a pelvic mesh mass tort in Philadelphia. In 2007, the woman had Ethicon’s Gynecare Prolift pelvic mesh implanted to treat POP. But soon afterwards, she began to experience complications. Surgeries to remove the mesh were unsuccessful, leaving the woman with continuing symptoms. She has constant pelvic pain, urinary incontinence and urinary tract infections, and pain after sexual intercourse that lasts for days. Her treatment options include additional surgery to remove mesh, pain injections and pain medications. But the lawsuit describes the woman’s injuries as permanent. Her attorney says she “will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life.”
FDA Warnings
In a 2011 safety communication for women and health care providers, the U.S. Food and Drug Administration (FDA) said serious complications associated with transvaginal mesh “are not rare.” Further, the agency said, it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
In January 2016, in response to thousands of lawsuits and reports of mesh failure and complications, the FDA issued two orders for transvaginal mesh devices. The first order reclassifies vaginal mesh devices from Class II, the moderate-risk device category to Class III, the high-risk category. The categories are assigned depending on how likely it is that a particular device will cause serious and permanent health consequences or even death. The second FDA order requires vaginal mesh manufacturers to submit premarket approval (PMA), the most stringent type of device marketing application required by the FDA.
Transvaginal Mesh Trial Outcomes
In April, a New Jersey woman was awarded $20 million in a transvaginal mesh trial. The first two trials against Ethicon and J&J had combined awards totaling $26 million. The $2.16 million award is the lowest thus far, and did not include punitive damages. The jury in this trial did not find the Prolift mesh to be defective and did not conclude that Ethicon failed to warn the plaintiff and her doctor about the risks associated with the Prolift mesh. But the jury did find that the risks of the Prolift mesh outweigh the benefits.
For the FDA to approve a medical device, the agency must conclude that the benefits must outweigh the risks for the intended use and for the patients involved. In this case, the jury found that the risks were higher, while at the same time noting the pelvic mesh did not, in the jury’s view, fail to perform as safely as a typical consumer might expect.
Help for Women Who Have Suffered Transvaginal Mesh Injuries
If you have suffered injuries or complications from a transvaginal mesh device or have needed additional surgery to remove the mesh or repair organ damage, the attorneys at Parker Waichman LLP can evaluate your legal options. For a free, no- obligation evaluation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
