Transvaginal Mesh Devices Linked to Pain and Injuries. The New Jersey Supreme Court has refused to hear an appeal of a vaginal mesh verdict filed by Ethicon, Inc., a unit of Johnson & Johnson, thereby upholding the $11 million verdicts.
The lawsuit alleged that Ethicon and J&J failed to give adequate warnings to women that Gynecare Prolift mesh products could cause debilitating nerve pain, Mass Tort Nexus reports.
National law firm Parker Waichman notes that thousands of women have filed lawsuits against transvaginal mesh device manufacturers including Johnson & Johnson, Endo, C.R. Bard, Boston Scientific, Cook Medical, and Coloplast Corp. over injuries the women say were caused by the companies’ mesh defective medical devices.
Plaintiffs in transvaginal mesh lawsuits allege the mesh devices become embedded in tissues and organs and cannot safely be removed. The mesh can migrate from the insertion site and sharp edges of the plastic mesh protrude into the vagina, causing pain, painful sexual intercourse, infections, urinary problems, bleeding, and recurrence of the prolapse or incontinence. Many women who were implanted with the devices have undergone additional surgery to remove the mesh and repair organ damage. Some women experience repeat episodes of mesh erosion and surgery to removed protruding mesh. Women have even reported that their male partners have suffered penis injuries from protruding mesh.
The U.S. Food and Drug Administration (FDA) has received thousands of transvaginal mesh adverse event reports. On January 4, 2016, the FDA issued an order to reclassify vaginal mesh devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices-devices that can cause serious and permanent health consequences or even death. A second FDA order requires manufacturers to submit premarket approval (PMA) application to support the safety and effectiveness of transvaginal surgical mesh.
Treating Incontinence and Pelvic Organ Prolapse
Vaginal mesh devices are implanted to treat women’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions that can occur when the pelvic structures are weakened by childbirth, surgery, or aging. When the pelvic structures that support the uterus, bladder and intestines weaken, the organs can drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems.
Transvaginal mesh devices provide support for weakened pelvic structures. But women and their doctors allege that both the design of the transvaginal mesh devices and the implantation technique can cause serious complications. Some women suffered bowel, bladder, or blood vessel injuries during insertion of the mesh. Studies have shown that one in 12 transvaginal mesh patients suffers complications from the device. Although the approved vaginal mesh devices as safe and effective within acceptable risk parameters, FDA approved vaginal mesh devices, the agency is now of the view that the mesh may not be the most appropriate treatment for pelvic organ prolapse (POP) when compared to traditional surgical procedures.
New Jersey Ruling Strengthens Other Cases
An attorney commenting on the New Jersey court ruling said the case “establishes certain key legal rulings are binding . . .which strengthens every case in this litigation,” Law360 reports. The jury had awarded $3.35 million in compensatory damages and $7.76 million in punitive damages.
Ethicon is involved in 31,752 product liability lawsuits in a federal multidistrict litigation (MDL) being overseen by U.S. District Judge Joseph R. Goodwin of West Virginia. In addition, legal observers expect a large number of lawsuits will be filed over injuries allegedly caused by Ethicon Physiomesh, a mesh product used in hernia repairs. A Physiomesh MDL could be formed as early as 2017, Mass Tort Nexus reports.
The case that was under appeal had been filed in 2008 by a woman who had Gynecare Prolift mesh implanted in 2006. But after the implant, she suffered nerve pain and she had 18 subsequent surgeries to remove the mesh. The constant pain made it impossible for her to continue her nursing career, the lawsuit alleged, and prevented her from having a normal sex life and enjoying time with her family.
In March 2016, the state appeals court that upheld the verdict wrote that the evidence was “sufficient to allow the jury to find an adequate warning would have prevented plaintiff’s injuries.” The plaintiff has testified that she would hot have selected the Prolift device if she had known the risks and known that Ethicon had information about Prolift that it did not provide to physicians, according to panel.