Since its approval to go on the market in 2002, the implantable permanent birth control device Essure has been the subject of much controversy. Thousands of women have claimed the device has caused pain, internal bleeding, miscarriages, and stillbirths. The FDA finally responded on April 9 by issuing an order restricting sales 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 on the market in the United States. A medical professional inserts the implant—flexible coils made of various metals—into the patient’s fallopian tubes by going through the vagina and cervix. When the device works correctly, scar tissue grows around the device over the next few months, building a barrier to prevent sperm from reaching and fertilizing eggs. However, some women have experienced perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and more as the device failed.
The FDA has received more than 25,000 “adverse event” reports regarding Essure since its entry into the market in 2002. Another report found that the implant may be linked to at least 303 fetal deaths. After the FDA began receiving these reports, they required Bayer, the manufacturer, to put a “black box” label on the device, which calls attention to the risks. Since the warning was added, sales dropped 70%, but many former users believed this warning was not enough—and the FDA agreed.
Now, with the FDA’s most recent order, Essure has tight restrictions on how it can be sold and distributed. Essure can only be distributed to health care providers and facilities that provide, review, and sign with patients a brochure that clearly outlines the risks of the device, entitled “Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgement.” If Bayer fails to comply with these restrictions, the FDA can take action, including implementing civil and criminal penalties.
Bayer released its own statement on the 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.
Public watchdog groups note that it can be difficult to get 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,” says Michael Carome of the consumer advocacy group Public Citizen.
Crandall & Pera Law works to protect the people of Ohio and Kentucky from dangerous medical devices. Our medical malpractice attorneys will fight for you and your health. Please call 877-686-8879, or fill out our contact form to schedule a no-obligation consultation.