Transvaginal Mesh Patients Face Risk of Ureteral Injury during Mesh Excision

Sept. 20, 2012 - PRLog -- A new study published in the American Journal of Obstetrics and Gynecology revealed women who suffered complications from transvaginal mesh used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) face an increased risk of ureteral injury during mesh excision or removal. [1]

Researchers from the Mayo Clinic and Spectrum Health Medical Group reported that the polypropylene mesh used to treat POP and SUI promotes fibrosis, or excess fibrous connective tissue.  The close proximity between the female productive organs and the ureter also creates a risk that the patient may suffer a ureteral injury during excision or a removal process.  Researchers also noted that 4.4% to 14.5% of patients have significant morbidity after the mesh kit procedures, including mesh erosion, infection, pain, incontinence, and recurrence of prolapse.  

This study data comes as no surprise as lawsuits continue to mount against multiple transvaginal mesh manufacturers, such as Ethicon (Johnson & Johnson), American Medical Systems, Inc., C.R. Bard and Boston Scientific.  While these are the four primary manufacturers, there are many others.  

On July 13, 2011, after receiving thousands of adverse event reports involving multiple transvaginal mesh devices, the FDA issued a Safety Alert, stating this was an "area of continuing serious concern," and it is unclear if the "mesh is more effective than traditional non-mesh repair and it may expose patients to greater risk." [2]

On November 21, 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a Joint Committee Opinion opining that due to the concerns about the safety and efficacy of the use of transvaginal mesh to treat pelvic organ prolapse (POP), it should be reserved for high-risk women for whom the benefit may justify the risk.  [3]

On January 3, 2012, the U.S. Food and Drug Administration (FDA) mandated postmarket surveillance studies be performed by 31 manufacturers of vaginal mesh devices, wherein they must conduct three years of studies on the devices’ safety and effectiveness.

It’s not too late.  If you or a loved one has suffered injuries caused by a transvaginal mesh device, contact Ennis & Ennis, P.A. for a FREE nationwide confidential consultation toll free at 1-800-856-6405 or complete an online case evaluation form at www.ennislaw.com.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

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[1] http://www.ajog.org/article/S0002-9378(12)00984-2/pdf
[2] http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices...
[3] http://www.augs.org/p/bl/et/blogid=3&blogaid=28