FDA right about transvaginal mesh warnings

Upon completion of their recently published study designed to “review the merit” of federal warnings about the transvaginal mesh, Texas and Louisiana researchers concluded that indeed “patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.”

That conclusion came from an article about the study, which has been published in the January 2013 edition of the medical journal Urology. That determination, in effect, has clinically reinforced warnings about the potential complications of the transvaginal mesh surgical kit procedure. The U.S. Food and Drug Administration issued those warnings in 2008 and in 2011.

Transvaginal mesh lawsuits have been filed by women who have suffered infections and other painful consequences of device defects.

The transvaginal mesh is surgically implanted to correct pelvic organ prolapse, a condition in which pelvic “organs bulge into the vagina,” and to treat stress urinary incontinence or the “leakage of urine during moments of physical activity,” according to the FDA.

Researchers from the University of Texas Southwestern Medical Center in Dallas and the Louisiana State University Health in Shreveport, La., tracked dozens of patients in a five-year span treated at two “tertiary institutions managing complications of transvaginal mesh,” according to the article, the co-authors of which included urologists Dr. Dominic Lee, Dr. Benjamin Dillon, Dr. Gary Lemack, Dr. Alex Gomelsky, and Dr. Philippe Zimmern.

Fifty-eight women treated from 2006 to March 2011 were studied. Only about a quarter of them were relieved of all apparent symptoms, the physicians wrote.

A lot of the patients suffered when the mesh penetrated tissue. More than a third had been through mesh removal surgery prior to their referral to one of the two “tertiary” facilities. The situation wasn’t pretty.

In the abstract, which the U.S. National Library of Medicine made available, researchers broke down the patients’ age range and summarized the results as follows: “Their mean age was 54.6 years (range 32-80), with a mean follow-up of 13 months (range 6-67). The mean interval to mesh excision surgery from the original prolapse surgery was 21 months (range 2-60). Of the 58 women, 35 (60%) had undergone concurrent midurethral sling surgery with the transvaginal mesh surgery. Also, 21 of the 58 patients (36%) had undergone initial mesh removal attempts before their referral to either tertiary institution.

“Most women presented with multiple complaints, with mesh extrusion the most frequently reported (n = 43 [74%]). Of the 58 women, 17 (29%) required re-excision of residual mesh, 13 once and 4 twice. Five women developed recurrent symptomatic pelvic organ prolapse (7%). The residual rate of dyspareunia and pelvic pain was 14% and 22%, respectively. Fourteen women (24%) were treated successfully, with complete resolution of all presenting symptoms.”

The FDA explained in a 2008 statement that the number of “adverse events” that POP and SUI transvaginal mesh patients had reported to the FDA numbered more than 1,000 for the previous three years. The number of subsequent reports of transvaginal mesh complications, according to administration figures, would skyrocket to 2,874 through 2010.

The FDA summarized the 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, 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.”

Per many plaintiffs: The transvaginal mesh posed unreasonable and uninformed risks. The suffering resulting from device failure and from the surgical and other measures intended to correct that failure seem immeasurable. The victims deserve compensation for their medical expenses and other losses.

The transvaginal mesh litigation team at Reich & Binstock has been offering free consultations to women whose complications may be related to the transvaginal mesh. Regardless of one’s state of residency, Reich & Binstock’s experienced product liability attorneys may be reached toll-free at 1-866-LAW-2400. One also may submit a request for free legal advice electronically through Reich & Binstock’s Web site, www.reichandbinstock.com.