Results of a New 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.”
This study is one of several conducted recently showing the ineffectiveness of transvaginal mesh. The first such study, “Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study,” in 2010, evaluated the long-term effectiveness of transvaginal mesh, and found that the devices failed in 30-50% of women studied. While the devices appeared to be effective for many women within 3 years of implantation, subsequent studies and recent bellwether trials have shown that device manufacturers have not properly tested the devices on living tissue, and have failed to warn surgeons and consumers about the potential dangers of transvaginal mesh products.
History of Transvaginal Mesh Problems
Transvaginal mesh was originally developed in 1996 and approved by the FDA for organ prolapse that caused vaginal pain and stress urinary incontinence. The original transvaginal mesh, Boston Scientific’s ProtoGen, was recalled in 1999, but due to an FDA approval loophole called 510(k) – which fast-tracks approval of devices similar to previously-approved devices – many other medical manufacturing companies began developing transvaginal mesh devices of their own.
Now, there are six multidistrict litigations (MDLs) against six major medical manufacturers, with thousands of plaintiffs claiming personal injury due to transvaginal mesh failure.
Those six MDLs are:
1. C.R. Bard MDL 2187: In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation.
2. Johnson & Johnson/Ethicon MDL 2327: In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation
3. American Medical Systems MDL 2325: In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation
4. Boston Scientific MDL 2326: In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation
- Mentor ObTape MDL 2004: In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation
- Coloplast MDL 2387: IN RE: Coloplast orp. Pelvic Support Systems
Recently, due to the high number of personal injury claims involving transvaginal mesh devices, CR Bard, Endo Health Solutions, Boston Scientific, Coloplast, and Cook Medical, began settlement talks. Reportedly, these five transvaginal mesh manufacturers faced a total of 30,000 personal injury lawsuits. Johnson & Johnson, meanwhile, has not agreed to any settlement talks and will continue facing bellwether trials in its MDL in Virginia.
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