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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2009 – Complications of TVM Use in 20% of Cases

Posted in Vaginal Mesh

In 2009, Robert M. Freeman and Gunnar Lose published a report aiming to weigh the benefits against the risks associated with transvaginal mesh use.  Transvaginal mesh (TVM) is a synthetic tissue substance used in the surgical repair of the vaginal or uterine wall following pelvic organ prolapse or another such ailment.

Published in The International Urogynecology Journal, the Freeman and Lose (2009) report was titled simply “The great mesh debate” and begins by asserting that there is an insufficient amount of research regarding transvaginal mesh to conclude anything about its safety: The evidence for most efficacy and safety outcomes was too sparse to provide meaningful conclusions about the use of mesh/graft in anterior and/or posterior vaginal wall prolapse surgery”[1]

Freeman and Lose suggest, rather, that the use of TVM “should be considered experimental … until such evidence is available that patients can be [counseled] accordingly.”[2]

Here is an excerpt from the report I found particularly poignant:

“The rationale for the use of mesh relates to the poor outcomes of traditional prolapse surgery especially for the anterior compartment. [Prominent medical researcher]Te Linde stated over 40 years ago that: ‘every honest surgeon of extensive and long experience will have to admit that he/she is not entirely and absolutely satisfied with his/her long-term results of his/her operations for prolapse and allied conditions’ [7]. It could be argued that not much has changed with 40% failure rates being quoted for anterior repair [8].”[3]

Though to be fair, Freeman and Lose also acknowledge “that it is relatively easy to publish a case report of a severe complication but that this can paint a falsely pessimistic picture.”[4]

However, the evidence that TVM use is dangerous and causes unnecessary complications is clear: about 20% of women that use TVM will require a second surgery to correct complications caused by the first procedure.[5]  “While these re-operation rates are not synonymous with failure, nonetheless, one would imagine that if after ‘failed’ primary surgery the symptoms were bothersome then patients would seek further treatment, whether that be with vaginal pessaries or surgery.”[6]

Suggesting that gynecologists around the country keep records of all “good” and “bad” outcomes of TVM use, Freeman and Lose write that eventually, doctors will be able to adequately inform patients about the safety of TVM.  In the meantime, we can plainly examine the available data: it is now widely-known that TVM use results in vaginal mesh erosion at least 10% of the time.

Due to the fact that many TVM manufacturers have failed to warn users of these risks, a number of transvaginal mesh lawsuits are currently being filed.  If you used TVM and experienced vaginal mesh erosion or another TVM side effect, please do not hesitate to contact our team of TVM lawyers.

For a free consultation, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

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

[1] Freeman, RM & Gunnar, L “The great mesh debate” Int Urogynecol J (2009) 20:889–891

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.