Transvaginal Mesh Products Provide Risks But No Benefits

Nov 6, 2013 - Pharmaceutical Litigation/Dangerous Drugs by Cross & Smith

Our Tuscaloosa defective medical device lawyers know transvaginal mesh products were sold by manufacturers with lots of promises to doctors and patients that the surgical mesh would make it easier to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). For thousands of women who began to experience complications after their TVM surgeries, however, the surgical mesh turned out not to live up to its promises.

Now, a new study has demonstrated that transvaginal mesh is not only unsafe but also that it is ineffective. The study was conducted by Georgetown University and published in the September issue of Obstetrics and Gynecology. The results are alarming and every patient who has had a mesh procedure or who is considering one should be aware of what the research showed.

TVM Study Reveals That Mesh is a Risky Treatment Choice

The TVM study involved following 65 women who suffered from pelvic organ prolapse. A total of 32 women had a surgical mesh implanted while the remaining patients had another treatment method for POP. The women involved were chosen for the study if they had completed a three-year validated quality of life questionnaire as well as a postoperative POP examination after either two or three years.

The study, unfortunately, was cut short after three years because of a 15.6 percent mesh exposure rate. Still, the three-year data indicated that:

• Three patients had died.
• Three patients had required an additional operation to treat their POP. All of these patients had procedures in which surgical mesh was implanted.
• Eight patients were not followed up on.
• Both the TVM and non-TVM patients experienced their most significant improvements in the first three years after the surgery.
• There was no difference in improvement scores for symptomatic relief among the TVM and non-TVM group.

This data thus revealed that after a three year period of time, there was no significant difference in the cure rates for patients who had vaginal mesh implanted during prolapse surgery as compared with patients who had procedures that did not involve the surgical mesh.

The study is likely to upset many patients who chose the TVM option because they believed it would help them to avoid recurrent prolapse and have a better success rate. Unfortunately, the fact that TVM procedures are no more effective than conventional treatments is especially disturbing given the serious complications that TVM patients can experience, which are not a risk with other procedures.

The complications are so common and so grave that the FDA was forced to issue a public health notification in 2009 alerting medical providers to more than 1,000 reports of adverse reactions associated with TVM since the mesh was approved on the market.

The FDA warned about erosion of the mesh within the body, as well as recurrent POP. Other problems included bowel, blood vessel or bladder perforation, vaginal scarring, urinary problems, and pain (especially during sex).

With no benefits over other courses of treatment and the serious and very real risk of complications, patients should strongly consider avoiding the use of mesh if they require surgery to correct stress urinary incontinence or pelvic organ prolapse.

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