Transvaginal Mesh Doctors’ Conflicts of Interest

Transvaginal Mesh Doctors’ Conflicts of Interest

Transvaginal Mesh doctors’ conflicts of interest could be dramatically impacting women’s healthcare.

We start with a simple premise: If a urogynecologist has a potential conflict of interest regarding the use of synthetic mesh as a treatment option for stress urinary incontinence (SUI), that doctor’s patients have a right to know about that potential conflict. Unfortunately, these conflicts are seldom, if ever, disclosed to the women they can affect.

A Few speak for All?

The American Urogynecologic Society (AUGS) – or, more accurately, a small percentage of its members who purport to speak for the whole organization – has gone out of its way more than once to promote the use of transvaginal mesh slings for stress urinary incontinence (SUI). It is more than a little unusual that the AUGS board has stated publicly how much AUGS supports and approves of the use of synthetic mesh to treat a condition which was treated surgically with sutures just as effectively as the mesh for more than 40 years.

Sutures vs. Polypropylene Mesh

One indisputable advantage simple suturing holds over the implantation of permanent synthetic mesh into a woman’s pelvic floor is that the former can be easily and safely removed, while a failure of the latter can result in lifelong scarring and permanent pain. It is usually impossible to retrieve all of the synthetic material once it enters the body and irrevocably begins binding to tissue. In the rare event that sutures cause more problems than they solve, the suture procedure can be reversed or repaired, at the very least to the point of returning the woman to the condition she was in prior to her surgery for SUI. The same cannot always be said for the synthetic mesh, which could result in nerve damage, permanent pain, permanent dyspareunia (painful sex), other organ damage, and the need for multiple explant surgeries.

AUGS Board Statement

Nevertheless, AUGS Board of Directors released a statement on Monday, Jan. 6 which claims: “The polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence. The procedure is safe, effective, and has improved the quality of life for millions of women.”

AUGS Fails to Disclose

This statement fails to disclose its authors’ financial ties to the synthetic mesh industry or the fact that a small percentage of AUGS members cannot be said to speak for all. Many urogynecologist members of AUGS disagree with this assessment, which also fails to explain how nearly three dozen different midurethral sling products on the market can all be said to represent a single “standard of care.” Given that each manufacturer stresses the differences between its sling and all the others, it is difficult to grasp the notion that ALL and ANY midurethral slings can be said to represent “the recognized worldwide standard of care.” Johnson & Johnson alone pulled four of its mesh products off the market in summer 2012, including mesh sling products which had been used for SUI, though the company claimed it did not remove the products for safety reasons.

Conflicts of Interest

AUGS web site reports that the organization represents some 1,700 members. AUGS also invites corporations to become members, such as those which make and market transvaginal mesh slings.  AUGS thanks its “corporate members,” which include  Allergan (the maker of Botox and the synthetic Lap band) and mesh sling makers such as American Medical Systems, Bard Urological Division, Boston Scientific, Coloplast and Ethicon (of Johnson & Johnson).

Corporate “Members” Undisclosed

AUGS fails to report this corporate support in its very public promotion of mesh for SUI. More importantly, it fails in its press releases – such as the Jan. 3, 2013 statement drafted by Charles Nager, Paul Tulikangas and Dennis Miller from AUGS – to disclose the conflicts of interests of at least five of its 13 board members. Conflicts of interest include arrangements where these doctors work as consultants, sit on advisory boards, accept research grants, work as speakers for, or even have proprietary interest in these companies. Dennis Miller has been a paid speaker for Johnson & Johnson, American Medical Systems (AMS), Boston Scientific, and has received substantial payments from each of those mesh-producing companies.

Financial Incentives for Doctors

Here is a quick snapshot of five AUGS board members’ names and the corporations with which the doctor has been or is connected by direct financial ties.

• Patrick J. Culligan: CR Bard, Intuitive Surgical, AMS, Boston Scientific, Origami Surgical;

• Roger P. Goldberg: Boston Scientific, Endo Pharmaceuticals, GlaxoSmithKline (GSK);

• Catherine A. Matthews: AMS, Boston Scientific, Pelvalon;

• Karen Noblett: Medtronic, Boston Scientific, Astellas, Allergan, Pfizer, GSK;

• Peter L. Rosenblatt: AMS, Ethicon (J & J), Coloplast, Cook Medical, Boston Scientific, Olympus Gyrus, Allergan, Pfizer.

Increased profits for Surgeons

St. Louis urogynecologist Dr. Wall warned in January 2010 that “powerful commercial interests are reshaping the field of pelvic surgery.” The proliferation of transvaginal mesh “kits,” he said, “hold out the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeon and the device manufacturer.”

Could AUGS ongoing promotion of synthetic mesh and these kits in place of tried-and-true suturing be a result of conflicts of interest between urogynecologists’ bottom lines and the health of their patients?

Conflicts of interest also abound for the self-proclaimed “Midurethral Sling Task Force,” which assembled the Jan. 3 statement. The force  included Eric Rovner and Howard Goldman from the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). Doctors with conflicts of interest on that “Force” include more industry-connected doctors:

• Dennis Miller: Johnson & Johnson, AMS, Boston Scientific, Allergan, Eli Lilly, Pfizer, AstraZeneca, Merck, Novartis;

• Eric Rovner: Allergan, Merck, Pfizer;

• Howard Goldman: Allergan, Merck, Pfizer, Valeant.

All Urogynecolotists in Agreement?

The 1,700 members of AUGS were not part of a random poll which could, at least in theory, find out whether or not they agree with the declaration of three doctor writers and 13 board of director doctors, nearly half of whom have clear conflicts of interest in promoting the use of a synthetic material as a “worldwide standard of care” for stress urinary incontinence. Are the board members smarter than the 1,700? Do they really speak for all 1,700? When is the last time you could name 70, or even seven, people who agreed about anything? Nevertheless, the “Midurethral Sling Task Force” and 13 members of the AUGS board purport to speak for 1,700 people.

At the very least, such pronouncements should come with caveats explaining how a very tiny percentage of AUGS members cannot be said to speak for all on issues concerning the health of millions of women, and what money, if any, they are receiving from the mesh industry. At the very least, those women deserve disclosures so they can make informed decisions regarding any salient factors that could affect their doctors’ judgment and advice to them. Women about to be implanted with a permanent surgical device deserve to know how (or whether) their very own doctor arrived at his or her own conclusion, and whether their doctor is aware of AUGS conflicts of interest which could unduly influence their own doctor’s judgment.

Check your own Doctor’s Conflicts of Interest

If you would like to check on your own doctor’s potential conflicts of interest regarding any treatment option, check out Propublica.org: Dollars for Docs. This site was developed for people who wish to gain what information they can regarding their own doctor’s potential conflicts of interest.