Update: On December 31, 2018, Bayer will end all U.S. sales of Essure birth control devices. The U.S. Food and Drug Administration (FDA) has received more than 26,000 reports of side effects like perforation of the fallopian tubes, device migration, chronic pain, bleeding and ectopic pregnancy. Thousands of women who experienced these side effects have file Essure lawsuits for damages.
Bayer said it has not changed its view of the safety and effectiveness of these devices. The company made this decision because of weak sales, not concerns about the device's safety. For years, Bayer has said Essure birth control devices are a safe form of birth control, even though the company has already stopped selling the device in Europe, Canada, South America, South Africa and the United Kingdom.
Bayer’s decision to halt all U.S. sales came just a few months after the FDA issued a unique restriction on the sale of Essure devices, restricting sales to health care providers who use an FDA-approved checklist informing patients about the potential risks.
This was the most recent in a series of FDA actions about Essure birth control devices. In March 2018 the FDA reported an increase in medical device reports involving removal of these devices. Demand for this product began to decline after the FDA added a black box warning in 2016. A black box warning is the strongest warning issued by the FDA.
Have You Suffered Side Effects from an Essure Device?
Essure birth control devices are flexible metal coils that are inserted into each fallopian tube to create a natural blockage to prevent pregnancy. The procedure only takes about 10 minutes and Bayer claims it is completely safe and almost 100 percent effective.
However, thousands of women have suffered serious side effects from these devices, from headaches and bleeding to pain in the abdomen, pelvis, arms, legs and back. Some women have even developed autoimmune diseases.
If you experienced side effects from an Essure birth control device, contact our defective medical device lawyers for a free consultation. We may be able to file an Essure lawsuit on your behalf to pursue compensation for medical expenses, pain and suffering, and other damages. We will represent you on contingency, so there will be no costs or fees unless you receive compensation.
Schedule a free consultation today by calling 1-844-RESULTS.
Reported Essure Side Effects
Essure is a nonsurgical, permanent birth control device that consists of a flexible metal coil that is inserted into each fallopian tube. The device is marketed by Bayer Healthcare and was approved by the U.S. Food and Drug Administration (FDA) to be sold to women as an alternative to other forms surgical sterilization, such as tying tubes.
Although Bayer Healthcare claimed Essure is a safe and effective means of permanent birth control, many women have reported suffering adverse medical complications after receiving an Essure implant. This includes reports of Essure coils causing women injuries such as perforation of the fallopian tube, neurological damage and sever pain. In severe cases, Essure side effects can be fatal.
Additional Essure complications and life-threatening side effects include:
- Chronic pelvic pain
- Allergic reactions to the nickel in the Essure implant
- Device migration
- Risk of ectopic pregnancy
- Device fracture
- Painful intercourse
- Heavy and irregular menstruation
- Weight fluctuations
If you have suffered adverse problems since receiving an Essure implant, do not hesitate to contact Roden Law. During our free, no obligation consultation we will help you determine if you may be entitled to compensation through an Essure lawsuit for the medical complications you have experienced.
Complete a Free Case Evaluation form to get started.
FDA Action Against Essure
In September 2015, the FDA convened an advisory council to discuss Essure’s safety and effectiveness after receiving thousands of reports of women suffering Essure complications.
Following the advisory council, the FDA ordered Bayer Healthcare to conduct a postmarket surveillance study to gather more data about Essure’s benefits and risks. The FDA approved the study plan on Sept. 2, 2016 to better understand the patients who may be at risk of suffering adverse Essure complications.
In response to the study’s preliminary findings, the FDA determined Essure required stronger warning labels to inform patients of the risks associated with the device.
In November 2016, the FDA required Bayer Healthcare to update Essure’s labeling to include a “black box warning” that alerted users about the device’s risk of organ perforation, device migration, persistent pain and allergic reactions.
However, Bayer Healthcare continues to market Essure as safe for most women and “99 percent effective when inserted properly and when women use birth control until a follow-up visit several months after the procedure.”
Call 1-844-RESULTS to discuss filing an Essure lawsuit.
Essure Lawsuits Filed Against Bayer Healthcare
Since Bayer Healthcare acquired the rights to Essure in 2013, numerous lawsuits have been filed by women who claim the pharmaceutical company was aware of Essure’s complications but failed to warn the public.
Additionally, Essure lawsuits allege Bayer Healthcare was negligent in its handling of Essure and that Conceptus Inc., Essure’s original manufacturer, forged documents to obtain Pre-Market Approval from the FDA.
Furthermore, many victims who have turned to legal action after suffering Essure complications have alleged Bayer Healthcare of failing to:
- Disclose thousands of Essure complaints of suspected device malfunction to the FDA
- Report adverse Essure side effects and actively concealing this information
- Complete a risk analysis for Essure
- Report incidents of bowel perforation, broken coils and Essure migration out of fallopian tubes
- Safely distribute Essure to qualified physicians
- Ensure the physicians recommending Essure to patients were qualified to sell the product
- Properly train doctors on how to use Essure
Contact our attorneys by calling 1-844-RESULTS.
Why Should I File an Essure Lawsuit?
Essure has been marketed by Bayer Healthcare as the only permanent, safe and highly effective birth control device that does not require surgery. However, several studies and thousands of reports from women suffering Essure side effects have shown this device may be defective and dangerous.
If you decided to receive an Essure implant and experienced adverse medical complications or side effects, you may be entitled to compensation. The attorneys at Roden Law will provide you with a free, no obligation consultation to review the complications you have suffered and determine if you may be entitled to file an Essure lawsuit against Bayer Healthcare.
By filing an Essure lawsuit, you may be able to recover compensation for:
- Past and future medical expenses
- Surgical expenses
- Lost wages
- Loss of earning capacity
- Loss of enjoyment of life
During your consultation, our attorneys will review your claim and discuss when you received your Essure implant and the severity of the complications you suffered. Our attorneys will then be able to use this information to accurately assess an accurate value of the damages you have suffered.
Complete a Free Case Evaluation form for qualified legal representation.
Contact Our Class Action Attorneys to File an Essure Lawsuit
If you experienced adverse medical complications after receiving an Essure device, do not hesitate to find out if you may be entitled to file an Essure lawsuit to obtain justice and compensation for your pain and suffering.
Roden Law’s attorneys have decades of combined legal experience advocating for the rights of injury victims. We strongly believe manufacturers have a duty to ensure their products are safe for users and work as effectively as they are marketed. When a manufacturer fails to uphold this duty, we will fight to hold it liable for its negligence.
We will provide you with a free, no obligation consultation with our team to discuss if you are entitled to file an Essure lawsuit against Bayer Healthcare. We will dedicate our skills and resources to your case without charging upfront legal fees, as we only require payment if we reach a fair outcome for case.