Wednesday, September 23, 2015

NEJM Calls for Revisiting Essure Safety

NEJM published Revisiting Essure - Toward Safe and Effective Sterilization, on the eve of the FDA's Panel Hearing on the Essure permanent contraceptive device. The Essure procedures works by inserting two nickel-titanium coils coated with plastic PET into the fallopian tubes, inducing scarring to prevent passage of the egg to prevent pregnancy. It states:

"The upcoming meeting of the Obstetrics and Gynecology Devices Panel represents a clear opportunity to impose requirements that will more fully elucidate the safety and effectiveness of Essure. A new study focused on patient-centered end points — unintended pregnancy, device migration, tubal perforation, bleeding, pain, and events such as hysterectomy and death — in all enrolled women is needed to provide clear estimates of device performance. Such a study should compare outcomes in women receiving Essure with those in women undergoing laparoscopic sterilization, the standard of care, and should be overseen by an impartial, off-site data and safety monitoring board performing periodic, planned reviews with follow-up for at least 5 years."

"The problems of inadequately rigorous premarketing and postmarketing studies, unregistered clinical trials, and incomplete and delayed dissemination of results are not unique to Essure. Most FDA-required postapproval studies are smaller than the premarketing studies, most follow patients for 1 year or less, and nearly half lack comparator groups.5 The 13-year history of Essure emphasizes the necessity for thorough examination and timely reporting of patient outcomes in well-conducted premarketing clinical trials and dedicated follow-up in postmarketing studies. Only then will we better understand the risks and benefits of various devices. In the case of Essure, these data would allow women to make more informed decisions regarding hysteroscopic sterilization." 

The stories, pictures and experiences women and physicians share at the FDA hearing Thursday are even worse.

Why not call for a moratorium on placement while additional post-market studies are conducted on women already implanted with the device, instead of multiplying the potential for harm, while serious questions of risk have surfaced based on evidence?

Who does the FDA calculation weighing risks and benefits of a device for approval, for warnings, and for removal from the market?  What factors are involved? Whose benefits, and whose risks?  It seems FDA weighs company benefits over patient risks.  Patient benefits are artificially inflated given the existence of safe and effective alternatives, and FDA seeks more to minimize company risks than patient risks.

Update: It was an honor to meet Dr. Ailene M. Gariepy, M.D., M.P.H. of Yale School of Medicine, co-author of this article, at the FDA Panel Hearing on Essure September 24th.

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