Is your physician ethical?

Alert to Utah Women!

According to Utah statute, ethical behavior is entirely unnecessary. State Code 78B-3-406, in a nutshell, states physicians do not have to inform you of any controversy or risks surrounding devices they may implant in you, as long as you loosely agree to the procedure. Utah Supreme Court of appeals state “This statute abrogates any claims for failure to disclose risks of treatment.” Consumers are not protected by the Food and Drug Administration either. Device manufacturers can submit similar devices under 510(K) without rigorous studies or animal research.

Faltering FDA oversight combine with this code leaving women in search of treatment for urinary incontinence especially vulnerable. The September 2010, Reader’s Digest list synthetic mesh slings to treat incontinence, as one device you’re better off without. They quote Donald Ostergard, M.D., past president of the American Gynecological Association and previous editor for the International Urogynecology Journal, stating “synthetic mesh slings for stress incontinence are a public health hazard.” At the 2008 International Continence Society meeting in Cairo, Ostergard, the keynote speaker, expressed views of senior colleagues, "they consider mesh use a sign of surgical incompetence."

Complications with mesh slings often appear more than three years postoperatively. A 2006 study published in Neurology and Urodynamics, reports major complications are estimated to occur 20-fold higher than reported. A rat study in the British Journal of International Urology (2004) found polypropylene (a common mesh) to invade the bladder muscularis in all of the implanted rats, stating “The use of polypropylene mesh risks serious postoperative complications, e.g. urethral tissue invasion.” Pharmaceuticals list animal studies in the Physician Desk Reference, information easily accessed on line or through a local pharmacy. It is unlikely a typical consumer would have access to peer reviewed journals discussing polypropylene.

In, How to treat pelvic organ prolapse, published by australiandoctor.com, inflammatory reactions to polypropylene never resolve causing chronic pain in 30%. In sexually active women the mesh behaves like a “cheese grater” when exposed to friction. Erosion occurs in 53% of patients. Exaggerated scarring from mesh shrinkage may result in anatomical distortion of the bladder, rectum and vagina. Other serious, disabling and life threatening injuries also occur. (australiandoctor.com 2010).

In 2009 the International Continence Society, agreed serious risks must be disclosed in the consent process, as many specialists regard polypropylene slings experimental (australiandoctor.com). I believe consent must also include unbiased information regarding other available treatments.

As an idealist, married to a physician, I believe an internal moral compass guides most physicians to honor their Hippocratic Oath. However, Utah code 78B-3-406, leaves women vulnerable to less ethical physicians, (shielded from litigation), as they may inappropriately capitalize on a growing trend in incontinence surgery.