What’s Going on With Essure in 2019
Essure permanent birth control was approved for the U.S. market in 2002 through a controversial FDA fast-track program that allows devices to enter the market with less vigorous testing then devices that go through the traditional approval process. By 2015, the government watchdog agency had received thousands of adverse event reports of complications and complaints.
Serious problems associated with the Essure device include:
- Persistent and chronic pain
- Organ perforation
- Migration of the device into the abdomen or pelvis
- Device breakage
- Abnormal bleeding
Unfortunately, some women who tried to have the device removed ended up having to have hysterectomies, and some were still left with long-term problems.
Long-Term Essure Safety Monitoring
Going into 2019, the FDA announced steps that it was taking to maintain oversight of the Essure birth control device after it was removed from the U.S. market. The watchdog agency said it was extending and revising the postmarketing surveillance study it ordered in 2016.
Initially, the study was designed to follow women who received Essure for three years. However, the FDA extended the study to follow recipients for five years in an effort to provide the FDA with longer-term data on adverse risks and issues that may result in the patient having the device removed.
The FDA is also requiring that women have blood tests during follow-up visits with their physicians to better understand complaints involving inflammation and autoimmune disease and study inflammatory markers and evaluate allergic reactions to the device.
FDA to Monitor Essure Safety and Effectiveness
In addition to the postmarketing surveillance study extensions and revisions, the FDA said it would also continue to monitor the device for its safety and efficacy. The agency will continue to review medical device reports, medical literature, post-approval study data, and clinical trial information. Any updates to the agency’s evaluation of data will be published for the public to review online on the Essure 522 Postmarket Studies Webpage.
Essure Labeling Update
In 2016, the FDA ordered Bayer to update Essure’s label after receiving thousands of complaints including reports of the deaths of four women and five fetuses. The updated label required a Boxed Warning with adverse events associated with the device through studies and in user experiences. Bayer was also ordered to include a patient checklist that highlights key risks and benefits of the device including probability rates for listed adverse events.
Are You Having Essure Problems?
Women who received the Essure permanent birth control device and suffered severe adverse events are turning to the legal system for help. These women allege they were never warned of the risks and dangers of Essure and were denied the opportunity to make informed healthcare decisions. If you or a woman you love was injured by Essure, contact us now. We have been fighting for women injured by birth control device for decades, and we are fighting for Essure victims now. Contact us now for a free, fully confidential, no-obligation case evaluation today and learn whether you are entitled to seek justice and compensation for the injuries you suffered from Essure.