Mesh Medical Device News Desk, January 11, 2017 ~ Transobturator tape used to treat incontinence, has twice the risk of re-operation as transvaginal tape, according to Danish researchers.
Danish researchers find that the risk of a re-operation with a TOT or transobturator tape was twice the risk in that country when compared to transvaginal tape (TVT).
TOT mesh was introduced in Denmark in 2003 and two years earlier in the U.S.
Both TOT and TVT are also called “tape” are are made of polypropylene, affixed to support the urethra as a treatment for incontinence. The TVT tape ends exit in the abdomen while the TVT-O passes through the obturator foramen and exits through the groin.
The TVT-O has been found to be defectively designed in at least two pelvic mesh trials..
Both meshes are a permanent implant, despite what a woman maybe told by her doctor when she expresses reservations.
THE DANISH STUDY
A population-based study was presented last year at the International Continence Society in Montreal, (Foss Hansen M, Lose G, Kesmodel US, et al. Reoperation for urinary incontinence: a nationwide cohort study, 1998–2007. Am J Obstet Gynecol 2016;214:263.e1-8.)
In this Danish study, a total of 8,671 women who were enrolled in the Danish National Patient Registry, were included who had undergone surgery to treat urinary incontinence between 1998 through 2007, with no prior incontinence surgeries. Among the initial group, 888 women were re-operated on within five years, making the rate of re-operation 10.2%.
Researchers were trying to determine the rates of re-operation within five years of various surgeries for stress urinary incontinence. Other types of surgery, besides TVT or TOT, include urethral injection therapy and Burch colposuspension.
The median time for the re-operations was one-year for sling surgery, two years for a Burch colposuspension and six-months for urethral injection surgery. Most re-operations occurred before the two-year mark after initial implant.
Factors such as body mass, severity of symptoms and skill of the surgeon were not analyzed. The study does not specify the definition of re-operation, that is, whether it was for pain, mesh removal, or to treat incontinence.
The transvaginal tape obturator (TVT-O) has been shown to be defectively designed in at least two product liability trials.
And still it remains on the market.
A study previously published (Cochrane Database Syst Review October 2009 and July 2015) found no significant difference between a TVT or TOT but was a small patient base of 7,476 women and lasted for one-year post-implant.
The Danish researcher, Dr. Foss Hansen, MD, suggests ideally more data should be derived from randomized, controlled trials.
Since TOT mesh was marketed by manufacturers such as Boston Scientific, Johnson & Johnson, and C.R. Bard, thousands of product liability cases have been filed against seven pelvic mesh manufacturers who who were not required to do long-term studies before marketing their products.
This study is notable because it is one of the few on the TOT surgery and it is considered long-term. Most mesh studies are short term, 12-months or less. ###