A clinical trial recruiting participants in the U.S. and in Germany, in effect, will check the reliability of recent science that is centered on the safety and effectiveness of the transvaginal mesh.
The mesh is surgically implanted, according to the U.S. Food and Drug Administration, to correct pelvic organ prolapse, a condition in which pelvic “organs bulge (prolapse) into the vagina,” and to treat stress urinary incontinence or the “leakage of urine during moments of physical activity.”
The suture procedure and transvaginal mesh implantation are two surgical ways to address these conditions. The clinical trial, in which researchers with the Mayo Clinic and with American Medical Systems are collaborating, is examining “both efficacy and safety of the two procedures and [is comparing] the surgical impact of mesh and suture repairs on [the] vaginal function” of women ages 21 to 80.
Researchers will look at three core criteria to determine whether each surgical technique will have been “successful” for the patient. A composite index will track the number of instances in which there will be a “lack of specific prolapse symptoms, [the incidence of] no interval treatment, and [the frequency of] no observed prolapse beyond 1 cm from the hymen.”
The primary outcome of the clinical trial is expected to be determined in December 2015.
Similar clinical trials have been completed. The outcome of a recent one was published in the May 12, 2011, edition of The New England Journal of Medicine. It concluded, in part, that mesh repair “resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events.”
Many of those adverse events resulted from serious and unreasonable risks.
The FDA summarized common complications as follows: “From 2008-2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.”
Obstetrician and gynecologist Dr. C. Sage Claydon said at a September 2010 Centers for Medicare and Medicaid Services forum that the transvaginal meshes “can also find their way into the bladder, into the urethra, into the rectum and/or into the muscle, the pelvic floor muscles, in such a way that they’re extremely difficult to remove, and we typically call that mesh erosion.”
She added that the mesh can also “grow into the muscle of the vagina, making it very difficult to get the mesh out, so we’ll have to take the patient back to the operating room, cut the mesh out, and try to reposition skin over. And we typically refer to that as mesh exposure…”
Considering that the ongoing and recently completed transvaginal mesh clinical trials are about comparisons of results, here is a comparison that a court in transvaginal mesh litigation might contemplate. A relative torrent of adverse event reports poured into the FDA in recent years. The administration said in a 2008 statement that the number of “adverse events” that POP and SUI surgical mesh patients had reported to the FDA numbered more than 1,000 for the previous three years. But from 2008 through 2010, “the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI.”
And those figures were merely FDA-reported adverse events — a narrow snapshot from a sprawling landscape of complications.
For too many women, the transvaginal mesh caused more complications than it was designed to treat. Their serious injuries were the result of a defective medical device. The victims deserve compensation for their medical expenses and other losses.
As for scientific re-examination, any comparison between the transvaginal mesh and another procedure does not mean that the mesh is safe. Anecdotally and otherwise, the medical device is, as plain as day according to injured women, unreasonably risky. Damaged plaintiffs in transvaginal mesh lawsuits can attest to that as they seek to hold accountable the parties who are culpable.
Implantation of the transvaginal mesh imposes unreasonable risk that is the result of a recklessly defective product, victims may assert. Accordingly, the transvaginal mesh is associated with a rash of suffering, re-hospitalization, and corrective surgery intended to alleviate that suffering. When that happens, thank goodness there is a justice system that can adjudicate the claims of the injured.
The product liability attorneys at Reich & Binstock [www.reichandbinstock.com] have filed transvaginal mesh lawsuits. They operate in every state. A woman who has suffered any of the unfortunate complications may want to contact one of the experienced transvaginal mesh attorneys at Reich & Binstock for a free consultation to determine whether there is an entitlement to compensation. Reich & Binstock may be reached toll-free at 1-866-LAW-2400.