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Contemporary research highlights TVM dangers

Posted in Vaginal Mesh

In the United States alone, over 300,000 pelvic floor reconstructions and urinary incontinence are performed.  Around 29 percent of these surgeries are reoperations.  The high failure rate of older methods gave way to the development of vaginal mesh kits in 2005.  Mesh-augmented vaginal prolapse repairs have shown to improve anatomical outcomes and are associated with low levels of recurrence rates.  However, the risk for significant complications are still pretty high: 2,874 complications associated with surgical mesh operations were reported from 2008 to 2010, as reported by the Food and Drug Administration.  50 percent of the 2,874 complications reported had to do with prolapse repairs.  TVM complications from vaginal mesh repair can have a significantly negative impact on a patients quality of life.  Many times, surgery is the only course of action that can correct the problem.

The objective of a study called “Recurrence of Prolapse After Transvaginal Mesh Excision”, published by the Division of Female Pelvic Medicine & Reconstructive Surgery at the Department of Obstetrics and Gynecology at Indiana University Health in Indianapolis, IN was to evaluate the anatomical and functional outcomes before and after surgery in patients undergoing mesh excision, and the study was a retrospective cohort analysis of patients who underwent mesh excision.  The POP quantification was used to evaluate the anatomical outcomes.  For the study, recurrence of prolapse was defined as stage II or higher-stage prolapse, reoperation for prolapse, or situations requiring “postoperative use of a pessary for prolapse reduction.”  The pelvic floor distress inventory was used when assessing the functional outcomes.

Author Amy George from the above article explains the results “Data were analyzed from 71 patients who underwent either partial or complete mesh excision. Most (44/70 [63%]) of the patients underwent partial mesh excision, and 26 patients (37%) underwent total mesh removal. Nineteen patients (26.7%) had preoperative prolapsed and 27 (38.0%) of the 71 patients underwent concomitant native tissue prolapse repair. Overall change in POP-Q stage in women who underwent partial removal (median, 0 [j1 to 2]) was less advanced than in women with total excision. (median, j1 [j3 to 0]; P = 0.006) at 1 year postoperatively.  Four patients prolapsed to the hymen, with all patients having defects in the anterior compartment.  No patients required a second surgery, and one patient was treated with a pessary.  Total pelvic floor distress inventory and pelvic floor impact questionnaire scores before mesh excision were significantly improved 6 months after mesh removal (P G 0.05). Dyspareunia improved significantly after mesh excision (P = 0.034).”  Partial and total mesh excision was concluded to be associated with re-treatment of POP in 1.4 percent of the patients, and functional outcomes were significantly improved after mesh removal.

In light of the fact that many studies such as this have shown the danger of transvaginal mesh, many TVM product manufacturers have failed to warn women of the many risks associated with vaginal mesh use.  And as such, a number of vaginal mesh lawsuits have been filed seeking financial compensation for these undue vaginal mesh injuries.

For more information or a free, no-obligation case consultation, contact our team of transvaginal mesh lawyers at the information provided below.

(855) 452-5529

justinian@dangerousdrugs.us

Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have any questions about Transvaginal Mesh.