FDA Restricts Sales of Essure Birth Control Device
Essure birth control went on the market in 2002, and since then the implantable permanent birth control device has been the focus of much controversy. Thousands of women, on their own or organized in support groups, have reported that the device has caused them chronic pain, internal bleeding, miscarriages, and stillbirths. This past April, the FDA finally responded by issuing a formal order restricting the sale and distribution of Essure.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, M.D. in the organization’s public statement.
The Essure birth control device is the only non-surgical form of permanent birth control available in the United States, and is 99% effective. The implant—flexible coils made of nickel and other metals—is inserted into the patient’s fallopian tubes by going through the vagina and the cervix. When it works correctly, scar tissue grows around the device over the next three months or so, which builds a barrier that prevents sperm from reaching and fertilizing eggs. However, some women experience issues such as perforation of the fallopian tubes or uterus, persistent pain, migration of the device to the pelvic or abdominal cavity, or other negative effects.
Since Essure went on the market 16 years ago, over 35,000 women have complained to the FDA about problems with the device, and one report found the implant could be linked to at least 303 fetal deaths. In 2016, the FDA required Bayer (Essure’s manufacturer) to put a black box label on the device, which calls attention to its risks. After the warning was added, sales dropped tremendously, but many former users believed the box warning simply was not enough, and the FDA agreed.
With the FDA’s April order, Essure now has tight restrictions on how it must be sold and distributed. The device may only be distributed to healthcare providers and facilities that provide and review with their patients a brochure that clearly explains the risks of Essure, entitled “Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgement.” The patient and doctor must both sign off on the acknowledgement. If Bayer doesn’t comply with these restrictions, the FDA can take action, which includes both civil and criminal penalties.
Bayer also released their own statement on the FDA ruling: “Bayer is deeply committed to providing women with safe and effective healthcare options that meet their individual needs, and is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception. As the FDA has repeatedly determined – after a rigorous review of the scientific evidence – Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option.”
Michael Carome of the consumer advocacy group Public Citizen also notes that it can be difficult to get problematic or defective medical devices off the market. “Once medical devices get on the market, it’s extremely difficult to get them off the market, even in the face of evidence suggesting that either they’re ineffective, or worse causing harm,” he says.
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Christopher T. Nace works in all practice areas of the firm, including medical malpractice, birth injury, drug and product liability, motor vehicle accidents, wrongful death, and other negligence and personal injury matters.
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