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Pelvic Meshes - “This is Industry-Driven Technology”

Those are the words of one Dr. David Grimes, who in July 2011, speaking to an NBC news reporter about the problems with pelvic meshes, added that “...we have a long history of accepting things without critical appraisal.”

By now, stories of the horrendous health complications suffered by women (as well as a small number of men) who have a pelvic mesh implanted in order to hold their organs in place have been well-circulated. Companies that manufacture these devices are facing a virtual army of injured plaintiffs, and are likely to wind up having to pay monetary compensatory damages (not that this will hurt their profits – not much – and not one executive will be jailed or suffer any personal consequences).

The harmful side effects of pelvic slings have been known for years. So – why haven't they been banned? Furthermore, why is the American  Urogynecologic Society (AUGS) so adamantly opposed to any restrictions on the use of mesh and sling products for the treatment of  pelvic organ prolapse (POP)?

Nearly two years ago, the advocacy group Public Citizen started a petition, supported by letters from two prominent physicians, asking the U.S. Food and Drug Administration (FDA) to ban all further surgical uses of non-absorbable pelvic meshes or slings, and to issue an order for manufacturers of such devices to recall all such products still on the market.

One of those physicians, Dr. L. Lewis Wall of Washington University in St. Louis, wrote in his own letter to the FDA that  “...the overriding ethical obligation of physicians should be to put the interests of their patients ahead of all other considerations,” pointing out that “Device manufacturers...see their primary obligation to be 'maximizing shareholder value' by increasing company profits.”

The other physician, Dr. Daniel Elliot, a urologist at the Mayo Clinic, stated in his letter that he has refused to treat his patients with pelvic meshes – but had treated patients who had received them elsewhere, and for years had seen the pain and suffering these women had been forced to endure as a result. He also told the FDA of

                                “the immense industry pressure on physicians to adopt the 'latest technology' without

                                proper prior surgical training and independent scientific evaluation...industry knowingly

                                targets less experienced physicians, knowing these kits have not, and never will be accepted

                                by more experienced surgeons who are fully aware of their inherent risk without benefit...

                                vast amounts of medical dollars are wasted on these trocar-mesh kits, through repeat physician

                                office visits for complications and through repeat surgical repairs”[italics mine].

Note that last part about “repeat visits” and surgeries. This is the “business model” of America's privatized, corporate-run health care “system.”  Recently, Dr. Andrew Weil, a professor of Medicine and Public Health at the University of Arizona, told a San Diego reporter that the U.S.  doesn't have a “health care system...we have a disease management system.” In the article, Dr. Weil pointed out that “75% of healthcare costs go to treating chronic diseases that are largely preventable, adding that “...there’s no money in helping patients prevent disease.” The reporter, John Lawrence, lays it out in black-and-white:

                                “The fee for service model guarantees that the money comes from treating and

                                retreating and retreating disease, not from preventing it in the first place. Physicians

                                routinely receive substantial compensation from medical-device companies through

                                stock options, royalty agreements, consulting agreements, research grants and fellowships.”

In light of that painful truth, is it any wonder that some in the medical industry are opposing any attempts on the part of the FDA to ban or even regulate these devices?

That is certainly a concern expressed by Dr. Anthony Visco, MD, who writes that “...a ban on mesh would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women,” adding his support for “...preserving all surgical options including transvaginal mesh for pelvic organ prolapse.” That letter was published in support of a position paper issued by AUGS in March of 2013.

In all fairness, Dr. Visco himself, who is Chief of Urology at the Duke University Medical Center in Raliegh-Durham and currently serves as AUGS president, has no business relationship with any of the pelvic mesh manufacturers currently facing litigation.  Rather, his letter reflects the views of the majority of his organization's members. Dr. Visco is also in favor of  “adopting recently published credentialing guidelines, standardizing the informed consent process and establishing a robust mechanism to track both surgeons and products being implanted to fully assess safety and efficacy.”

That said, the evidence is out there – and there are experienced professionals in the medical community who continue to take issue with the position of AUGS. And of course, let's not forget the elephant in the room that only Dr. Weil and a few others are talking about, here – the whole corrupt, for-profit nature of American medicine.

Such corruption can ultimately affect even those individuals and institutions with the most noble intentions.

Sources

Elliot, Daniel MD.  Letter in Support  of Public Citizen Petition to the FDA, 19 August 2011. Available at https://www.citizen.org/petition-to-fda-to-ban-surgical-mesh-for-transvaginal-repair-of-pelvic-organ-prolapse .

Lawrence, John. “Hospitals to US Citizens: Your Money or Your Life.” San Diego Free Press, 22 March 2013. Available at http://sandiegofreepress.org/2013/03/hospitals-to-us-citizens-your-money-or-your-life/

Rubin, Rita. “Risky Pelvic Mesh Highlights Worries About FDA Process.” MSNBC, 26 July 2011. Available at http://www.nbcnews.com/id/43886793/ns/health-health_care/t/risky-pelvic-mesh-highlights-worries-about-fda-process/#.UW3WPrWTgzd .

Visco, Anthony MD. “AUGS Position Statement on the Restriction of Surgical Options for Pelvic Floor Disorders.” 26 March 2013. Available at http://www.augs.org/p/bl/et/blogid=6&blogaid=160 .

Wall, L. Lewis MD. Statement in Support of Public Citizen Petition to the FDA, N.D.  Available at https://www.citizen.org/petition-to-fda-to-ban-surgical-mesh-for-transvaginal-repair-of-pelvic-organ-prolapse .

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