August 9, 2012, by Amy Gezon ~
In the weeks preceding the first landmark settlement against the manufacturers of surgical mesh implants used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the New England Journal of Medicine (NEJM) (here) published an article promoting the prophylactic use of mesh slings at the time of hysterectomy.
The article describes the findings of the OPUS study comparing Gynecare TVT, manufactured by Ethicon, a Johnson & Johnson (J&J) subsidiary, against a sham procedure for the prevention of SUI. The NEJM’s publication of this manuscript promoting the use of this product comes on the heels of J & J’s announcement to discontinue sales of four Gynecare mesh products including the TVT Secur™.
The withdrawal of the four products follows a March 16th report by Bloomberg that J & J marketed one of their Gynecare mesh products without the approval of the FDA for three years beginning in 2005.
J & J’s withdrawal of Gynecare mesh products is only one of many shortcomings.
The OPUS trial fails to address concerns identified through the FDA’s meta-analysis of synthetic slings for SUI reported at a public hearing on September 9th, 2011 following a dramatic rise of serious adverse events reported between 2008 and 2010. The FDA noted a significant rise of serious complication reporting since they released a warning in 2008.
The FDA noted many serious adverse events did not occur until 3 years or later following mesh implantation, the OPUS followed patients for 12 months. The study’s lead author John Wei, M.D. of the University of Michigan and co-authors report 6.3 women will need to receive the sling for 1 woman to benefit with international studies reporting a 10-1 ratio (reference http://www.springerlink.com/content/kn412382526k3h2l/fulltext.html).
About half of the sling recipients in this study still developed SUI. So as one woman benefits from a procedure for a condition of limited morbidity, she and 6-10 others expose themselves to complications including organ perforation, dyspaurenia (painful intercourse), urinary obstruction, long term catheterization, surgical revisions, nerve entrapment, severe chronic pain, erosion and mesh contraction. Additionally, emotional well-being deteriorates as a result of painful and degrading procedures, surgeries, examinations and impaired intimacy.
MDND reported on Dr. Wei’s study here.
The failure of this research team to address certain adverse events such as neuromuscular pain and dyspaurenia is not surprising, as few surgeons acknowledge any issues with mesh placed for the treatment of SUI. At the September 9, 2011 hearing, the FDA presented an analysis of the reported serious adverse events. The voluntary reports to the FDA by patients experiencing serious adverse events were not represented in this review. Of the 1,371 reports filed with the FDA only 95 were reported by health care providers or the facilities implanting the devices. With only 6% of events reported by providers, safety surveillance remains in the subjective discretion of industry.
The published manuscript in the NEJM marginalizes adverse events only briefly addressing a few of the known adverse events including incomplete bladder emptying and urinary infections. The OPUS study is spun positively however recent rulings in multidistrict litigation (MDL) against multiple manufacturers of vaginal mesh implants raise suspicion about the safety of these products.
A New Jersey Superior Court judge’s rejection of attempts to block the depositions of J & J’s top executives precedes the first landmark settlement involving a mesh sling for the treatment of SUI.
On July 23, 2012 a jury awarded Christine Scott 5.5 million to be paid by Bard and her surgeon who will pay 40% for damages (background story here).
The NEJM’s decision to publish this study riddled with controversy and so many shortcomings should concern all clinicians and healthcare consumers. Although thousands of lawsuits are pending, treating a condition of limited morbidity with a device identified by the FDA in 2008 to cause profound morbidity in some, has not changed the practices of most surgeons treating female urinary incontinence.
As Scott’s verdict did hold the surgeon partially accountable, perhaps surgeons will take greater interest in the care of their patients rather than relinquishing the future of their practice to industry and attorneys. #
Amy Gezon is a recovering mesh patient who had a Boston Scientific sling removed in November, 2010. Since then she has become a patient advocate and is beginning the third year of a master's program to become a Clinical Mental Health Counselor. Prior to that she worked as a clinical research coordinator, managing a variety of pharmaceutical-sponsored antibiotic clinical trials in a community based hospital for 16 years.