In a recent transvaginal mesh lawsuit, expert testimony supplies a revealing look into the way some products become available prior to pre-market clearance to confirm safety and efficacy. In May 2016, a plaintiff was awarded $2.16 million in compensation for pain and suffering due to transvaginal mesh (TVM) complications linked to an allegedly defective Prolift mesh.
The plaintiff dropped several of her claims against manufacturer Ethicon, a subsidiary of Johnson & Johnson, in the course of the trial. Although there were no punitive damages awarded, the jury ultimately awarded the TVM lawsuit plaintiff over $2 million.
An expert witness presented a report that profiled Prolift as misbranded and adulterated due to an alleged lack of adequate clearance as required through the fast track 510(k) process. A 510(k) is a pre-market submission made to the U.S. Food and Drug Administration (FDA) that must demonstrate that a new product is at least as safe and effective, and “substantially equivalent” to a similar product already approved by the FDA.
National law firm Parker Waichman LLP has extensive experience and success in medical device litigation, including transvaginal mesh implants. The firm’s attorneys are available to answer legal questions from individuals seeking information for a potential lawsuit.
Gynemesh 510(k) Clearance
An earlier Ethicon product, the Gynecare Gynemesh PS had been approved by the FDA through the 510(k) process. This signified that Gynemesh PS was assumed to be substantially equivalent to a product previously approved, already available, and performing properly.
However, the Gynecare Prolift Pelvic Floor Repair System was described by Ethicon as a line extension of the Gynecare Gynemesh PS. Prolift, therefore was brought to market in March 2005 without a 510(k) clearance. The allegation is that the FDA was not made aware of the existence of Prolift.
The pre-cut Prolift surgical mesh was made from the same non-absorbable polypropylene material used for Gynemesh PS. In 2004, a year before Prolift was introduced, there were two, non-randomized and non-controlled studies conducted by Ethicon. According to the expert witness, studies were also performed at eight sites in France and three sites in the U.S. In the French study, 20 percent of the study participants suffered dyspareunia (painful intercourse). In total, 25.6 percent of participants experienced transvaginal mesh complications. Similar adverse events were suffered by 65.9 percent of patients in the U.S. study.
According to court records and study results, Ethicon Prolift was made available to the public in 2005 without an FDA 510(k) clearance. Ethicon claimed that the Prolift transvaginal mesh was exempt from 510(k) clearance because Prolift was a custom device. The expert witness disagreed with this assessment remarking that neither the Prolift device, nor instruments made for Prolift application were custom devices and therefore were not exempt from compliance as specified in the 510(k) pre-market approval requirements. The expert witness maintained that Ethicon had marketed a product that violated ethical and safety standards.
In late May, a federal judge in West Virginia dismissed 97 transvaginal mesh lawsuits that were described as having been compromised, and therefore, were settled. Terms of the settlement were overseen by U.S. District Court Judge Joseph R. Goodwin. There are still thousands of TVM mesh lawsuits pending.
Transvaginal mesh, also known as pelvic mesh, is surgically implanted in women to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Lawsuits continue to be brought by plaintiffs over allegations that the transvaginal mesh devices caused them infection, bleeding, severe pain, erosion of internal bodily tissue, dyspareunia, painful scarring, as well as other injuries. Plaintiffs also frequently maintained that these adverse reactions required surgical removal of the device.
The FDA issued warnings about transvaginal mesh implants both in 2008 and 2011. The agency updated its previous notice in 2011 to show that complications linked to transvaginal mesh were “not rare,” and indicated that transvaginal mesh does not seem to have any obvious benefits for patients diagnosed with POP when compared to non-mesh methods.
The FDA indicated the most common injuries reported due to use of the transvaginal mesh are: infection, incontinence, pain, mesh erosion, recurrence of prolapse, and urinary problems. Women also reported injuries including perforation of the bowels, bladder, and blood vessels connected to the implantation of transvaginal mesh devices.
Advice and Information for Transvaginal Mesh Recipients
If you or someone you know suffered injuries regarding the use of transvaginal mesh implants, you may be eligible for legal compensation. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).