Why the FDA requires the Essure Patient Decision Checklist
In April 2018, the FDA required Essure to make significant enhancements to its warning label to better disclose the risks to women and their doctors. The FDA mandate also required women considering Essure for permanent birth control and their doctors to complete a Patient Decision Checklist to ensure they fully understand and appreciate the risks and potential complications of the IUD. Physicians are required to provide and review this document with patients considering Essure and obtain a patient signature indicating consent. The checklist is accompanied by a 16-page patient brochure, one-half of which is devoted to safety information for the product.
The fact the FDA now requires the Patient Decision Checklist is evidence that the original disclosures fell short of adequately warning patients of Essure’s risks and side effects such as device migration, organ perforation and internal organ damage. There are thousands of women who should have been told the truth, but Essure failed to do that.
Before Essure was recalled, more than 750,000 women received Essure implants. From these patients, the FDA has received over 32,000 complaints and 10,000 adverse event reports related to Essure problems. Over 300 fetal deaths have been linked to Essure defects because of ectopic pregnancies in women who believed they could no longer become pregnant. The FDA even noted the skill level required to properly implant the coils in their proper position is beyond the level of most OBGYN doctors.
What critics are saying about the Essure Patient Decision Checklist
Critics claim the Essure Patient Decision Checklist is too complicated and falls short of providing the information patients need to make an informed decision. One public health advocacy group assessed the readability of the Checklist to be at a college level and stated the document is much too long and complex for the average person to understand. The FDA has set the approved readability level for such documents at no higher than 8th grade. Additionally, the FDA only provides the Checklist in English. While Bayer has a Spanish version on their website, there are limited resources for those who speak other languages.
Common injuries and side effects linked to Essure
Many women have experienced severe side effects and complications from Essure after implementation. For such patients, Essure coils can be surgically removed, however fertility is not typically restored. The long list of common injuries and side effects from Essure includes:
- Heavy bleeding and discharge
- Abnormal blood clots
- Severe bloating and weight gain
- Migraine headaches caused by metal allergies
- Debilitating chronic pain
- Full or partial hysterectomy
- Coil migration
- Coil breakage
- Autoimmune disorders
- Hair loss
- Back pain
- Perforation or tearing of the pelvic organs
- Abdominal surgery
- Ectopic pregnancy
- Wrongful death
There are currently more than 18,000 lawsuits against Essure’s manufacturer alleging that Bayer knew about the design defects and the injuries to women but failed to provide stronger warnings so that doctors and patients could make an informed decision.
You may have a claim for damages against Essure
If you have suffered injured related to a defective Essure IUD, you may qualify to join a mass action lawsuit that has been filed against Essure manufacturer Bayer A.G. Case Works is not a law firm, but we work with some of the best attorneys in the nation and can help you get connected with one of them to evaluate your case. CLICK HERE to get in touch with us.