If a medical device injures thousands of women and causes hundreds of fetal deaths, how do you think the US Food and Drug Administration (FDA) should react? Most people would answer: take the device off the market until it’s proven to be safer. Unfortunately, that’s not what the FDA did about thousands of complaints about Essure side effects.
What Is Essure?
Essure is a “permanent birth control” (sterilization) method for women. It consists of two metallic, spring-like devices which are implanted non-surgically into both of a woman’s Fallopian tubes. The device induces scarring, creating a blockage that prevents eggs produced by the ovaries from reaching the uterus.
The FDA approved Essure in 2002. It is marketed and manufactured by Bayer.
A 13-Year History of Women’s Complaints
Since its approval, more than 5,000 women have filed formal Essure complaints with the FDA, alleging that the device resulted in pregnancies, miscarriages, and stillbirths – which it was intended to prevent – as well as severe pain and bleeding.
Fetal Deaths Associated With Essure
At least 300 fetal deaths are also attributed to Essure. This portion of Essure complaints likely represents only a portion of those affected by the device’s defects, as only a woman’s first fetal death was included in the reporting even if she had suffered through multiple miscarriages.
FDA Mandates “Black Box” Warning Label
To date, the FDA’s response to Essure complaints has been twofold:
- Bayer has been ordered to gather “postmarket surveillance” (PS) in a “real-world environment” to better understand Essure’s “benefits and risks.” Although the FDA requires PS studies to be conducted “in the least burdensome manner,” it doesn’t say whether the burden affects the patient or the manufacturer.
- The FDA will require a black box warning, its strongest safety warning, to be printed on the prescribing information sheet that accompanies Essure. Black box warnings usually highlight problems that “may lead to death or serious injury.”
What Happens If Bayer Doesn’t Comply?
Bayer has 15 months to begin the FDA’s required PS study on Essure or risk the product being declared “misbranded,” which could result in Essure’s removal from the market.
For the time being, the FDA is allowing Essure to remain on the market, saying the implants still remain “an appropriate option for the majority of women seeking a permanent form of birth control.”
Strong Comments Against the FDA’s Inaction
The FDA’s reluctance to pull Essure from the market has elicited strong reactions from some doctors and has even gotten the attention of Congress. Representative Mike Fitzpatrick (R-Pa.) calls into question the need for additional research like the PS report. He believes there’s already plenty of evidence to pull Essure off the market.
Possible Kickbacks From Bayer to Doctors?
Congressman Fitzpatrick also alleges that “the manufacturer of Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure.” The Congressman references a legal complaint claiming that Bayer provided free medical equipment, meals, and marketing services to what he called “coin-operated doctors” who would then encourage Essure’s use to patients.
FDA’s Trustworthiness Is Questioned
Madris Tomes, an analyst who studies FDA public data, told CNN, “I feel as if the FDA truly failed these women.” In pondering why the FDA didn’t move to recall the device after seeing more than 5,000 Essure complaints, she voices the question that most of us are thinking: “How can we trust the FDA to make good decisions regarding safe and effective devices?”
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