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Whose Responsibility Is It Anyway? How the Removal of Just One Word Created a Heyday for Transvaginal Mesh Surgeries
More often than not the big news in life is the hardest to hear; we rejoice when the news is good, but when the news is bad, sometimes all we can do is work our way through the stages of grief. First comes denial, then anger, then bargaining, depression and acceptance.
And as such, we hate to be the bearers of bad news, but here it goes: Transvaginal mesh implantation surgery would not be so widely used today had the medical profession publication, the American College of Obstetricians and Gynecologists, not backtracked on what they knew to be inadequate safety warnings for their patients.
Even before the FDA’s own public health alert regarding transvaginal mesh, the American College of Obstetricians and Gynecologists issued a bulletin, in February of 2007, stating that transvaginal mesh surgery should only be regarded as an experimental treatment option. In fact, the bulletin said, “Given the limited data and frequent changes in marketed products (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks, especially mesh erosion), the procedures should be considered experimental and patients should consent to surgery with that understanding.”
However, most patients were never told the full story – they did not understand the risk factors, the experimental nature or the increased risk for erosion – things that many patients we are working with for the transvaginal mesh lawsuit say would have made them say “no” to transvaginal mesh and yes to an alternative treatment plan. And to make matters worse: in the American College of Obstetricians and Gynecologist’s second transvaginal mesh bulletin seven months later, the experimental word disappeared from the bulletin. Instead, the bulletin read: “Given the limited data and frequent changes in marketed products for vaginal surgery for prolapse repair (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks, especially mesh erosion), patients should consent to surgery with an understanding of the post-operative risks and lack of long-term outcomes data.”
So where did the “experimental” word go? Some physicians are speaking up, saying the cause may be as old as business itself: Show me the money.
You see, surgeries understood as experimental are not covered by third-party insurance due to insufficient safety evidence, an important fact, as medical surgeons and clinicians receive a substantial portion of their income from insurance. And by taking the word “experimental” out of their second bulletin, the American College of Obstetricians and Gynecologists was able to secure more future transvaginal mesh surgeries, and make sure that future surgeries were covered.
Insurance income. Patient safety.
Which would you chose?
In a January 2010 article, a St. Louis urogynecologist, Dr. Wall, cautioned “powerful commercial interests are reshaping the field of pelvic surgery [and] [transvaginal mesh kits] hold out the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeons and the device manufacturer.” (http://commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh)
We agree with Dr. Wall.
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