Alexa

Details of Transvaginal Mesh Market Approval Cannot Be Used as Evidence

Judge in Ethicon Transvaginal Mesh Case Says Marketing Details Cannot Be Used as Evidence

transvaginal meshThe federal judge in the Johnson & Johnson/Ethicon transvaginal mesh case has ruled that details regarding how the transvaginal mesh device was introduced to the market cannot be included as evidence in the bellwether cases, because it could confuse the jury.

US District Court Judge Joseph R. Goodwin is managing several multidistrict litigations (MDLs) against a variety of transvaginal mesh manufacturers including Ethicon (a subsidiary of Johnson & Johnson), American Medical Systems, Boston Scientific, Coloplast, CR Bard, and Cook Medical. Currently, there are 37,000 personal injury lawsuits in the transvaginal mesh MDLs.

Judge Goodwin stated in his 21-page ruling that nuances in the regulatory process “poses a substantial risk of misleading the jury and confusing the issue.” J&J’s Gynecare T&T mesh device was reportedly made from the same material used in Prolene sutures, which the FDA deemed to be safe for human use. Because of the similarity in the material, the Gynecare transvaginal mesh device was able to go through the FDA’s 501(k) regulatory process, which means it was expedited without additional testing. Judge Goodwin believes that details of this process will detract from the overall concerns raised in transvaginal mesh personal injury lawsuits.

“Ethicon would like the court to determine that because the FDA found polypropylene is safe to use as a suture, it is automatically safe to use in transvaginal mesh,” he wrote. “Although purportedly constructed of the same material, it is a different product, used in a different manner, for a different purpose.

“Essentially, Ethicon argues that because the FDA confirmed the safety and effectiveness of the Prolene suture, and the TVT is composed of the same material as the Prolene suture, the plaintiffs should be barred from arguing that the Prolene material is defective…At first glance, this argument appears to have some merit — after all, the FDA gave the Prolene suture its stamp of approval and confirmed its safety and efficacy.”

Goodwin said that Ethicon’s argument ignores the fact that Prolene sutures are not used for the same procedures as transvaginal mesh devices.

“Although Ethicon represents that the products are primarily composed of the same material, it does not automatically follow that the material is safe in both devices,” he said.

Results of Study Show that Transvaginal Mesh is Ineffective in Prolapse Repair

The findings of a recently published study show that transvaginal mesh is not beneficial for the repair of vaginal prolapse.

The study, conducted by Robert E. Gutman, MD, from Georgetown University in Washington, DC, was published in the September 6th online version of Obstetrics & Gynecology.

The transvaginal mesh study looked at 65 participants, and found no difference in cure rates for women with or without the use of the mesh devices. The authors are quoted as saying: “There was no difference in three-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh.”

The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case

Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.

Leave a Reply

BestLawyers.comAVBetter Business Bureau