Thousands of women throughout the United States have suffered life-altering complications through the use of a permanent contraceptive device called Essure, manufactured by Bayer AG.
The device, originally marketed as a safe and effective non-surgical alternative to tubal ligation, first received clearance from the FDA in 2002. Since then, however, there has been enormous cause for concern that the product may not be as safe as previously thought. The FDA is currently weighing the risks and benefits of this defective medical device to further investigate the potential to harm users.
- Reported side effects have included:
- Chronic pain
- Heavy bleeding
- Debilitating fatigue
- Migration of the device into the pelvic cavity
- Unintended pregnancies and stillbirths
- Autoimmune disorders, including psoriasis and lupus
Have you or someone you know experienced life-altering side effects linked to the use of Essure contraceptive device? Contact a Houston product liability lawyer for a FREE consultation.
The FDA’s Response: Essure Device Investigations
More than 5,000 adverse side effects have been reported to the FDA in connection with the device. While the exact cause of the device’s failure has yet to be determined, it has been conjectured that a latent manufacturing issue could be responsible for a large number of reported problems. Another theory has suggested that nickel and other metals that the device is made from could potentially cause an allergic reaction leading to the onset of symptoms.
The FDA is determining whether to restrict the device in some groups of patients as well as whether to make changes to the device’s label. Further clinical trials may be conducted as the FDA weighs its options for how to move forward. Additionally, the FDA recommended further training for doctors, including how to effectively remove the device as well as to have an intervention plan in place if the patient complaints about persistent pain early on.
Have You Suffered Painful Essure® Side Effects?
Bayer and the FDA should never have allowed a dangerous product into the market without fully understanding and disclosing the risk of serious side effects. This failure to warn the public is not only deceptive, but it has proven unacceptably dangerous. If your health has been compromised by the defective contraceptive device Essure, contact a Houston product liability attorney at Fibich, Leebron, Copeland & Briggs. You may be entitled to pursue compensation to cover the costs of your medical care, pain and suffering, and more.
Get started with a free case evaluation by filling out our online form or by calling (713) 999-3681.