Ensure Ethical and Balanced FDA Mesh Research

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The role of mesh in pelvic prolapse surgery has been under critical debate.  Many surgeons rely on these devices to provide an efficient, effective cure for complex or recurrent prolapse, and to allow the option of preserving the uterus rather than requiring hysterectomy. Numerous studies, including NIH sponsored trials, have established that current mesh procedures, such as Uphold Lite, have an excellent safety profile.

In order to more fully assess the mesh procedures currently available and relied upon by many surgeons, and ultimately ensure the best array of surgical options for present and future patients, the postmarket -522 studies were mandated by the FDA.   These studies were fully enrolled with great effort, expense, and with an ethical understanding that the 3-year assessment described in the study protocols would provide the key outcomes required to answer clinical questions and determine the best regulatory decisions.

On 4/16/19, the FDA abruptly mandated removal of Uphold and other prolapse mesh, based on interim review of 1-year outcomes and with no safety issues triggering concern.  The undersigned physicians believe this action occurred primarily due to outside pressures having no relationship to the scientific evidence, and that these factors have ethically compromised the planned interpretation of the -522 trials.

The undersigned physicians consider the proper conduct and interpretation of these studies to be a critical ethical commitment to the human subjects that have been enrolled.  The 2010 Institution of Medicine Consensus Report stated:  "It is never ethical to involve research participants in a ... study that does not have a reasonable prospect of answering the research question under study.  In the case of postmarking clinical trials required by the FDA, that ethical precept requires further specification and strengthening.  It is also critical that the clinical trial be designed to provide precisely the data needed to facilitate the policy decision that needs to be made, aiming to challenge and improve the understanding and treatment of disease."

The undersigned have organized to formally petition the FDA to protect the ethics and intent of the -522 studies, and to ensure these challenging circumstances result in the best outcome, by reserving final regulatory determinations until the 3 year study period has been reached.  Additionally, we believe the FDA should include proper representation from practitioners in our specialty, and also consideration of highly relevant non-522 clinical trials that provide critical insight into these procedures and their importance in women's healthcare.