Since the permanent birth control device Essure went on the market in 2002, 26,000 complaints and 16,000 lawsuits have been filed against Bayer, the manufacturer of the device. As a result of the chronic and debilitating side effects (nickel poisoning, abnormal/heavy menstrual bleeding, autoimmune disorders, severe abdominal/pelvic pain, etc.) caused by Essure, many women have had to have the device removed. However, prior to implantation, women were not only ill-informed about the side effects of the Essure device, but they were never properly warned that if removal would be necessary, the removal may involve a total (uterus and cervix) or partial (uterus only) hysterectomy. In light of the safety concerns raised by the thousands of complaints and lawsuits, the FDA recently restricted the sales of the Essure device to only those doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”, which includes a warning about the invasive removal process.

Despite the concerns associated with removing the device, to this day, Bayer has never trained physicians on proper removal techniques. Many people fail to realize that while the majority of the Essure micro-insert is implanted into the fallopian tube, there are several trailing coils that run through the ostium (opening of the fallopian tube into the uterus) and extend into the uterus. As such, performing a salpingectomy (removal of one or both fallopian tubes) to remove the micro-inserts may not completely remove the device. This is due to the fact that the cut during a salpingectomy, to sever the fallopian tubes from the uterus, is made at or about the ostium. Consequently, the portions of the micro-inserts that extend into the uterus may end up getting left behind, and likely will continue to cause problems or additional injuries for the patient in the future. Likewise, a partial hysterectomy (removal of the uterus only) may not completely remove both micro-inserts as portions of each may still remain in the fallopian tubes once the uterus has been removed. Accordingly, the most effective method by which to remove the Essure micro-inserts involves only removing the portions of the fallopian tubes and uterus containing the micro-inserts (cornuostomy and ipsilateral salpingectomy). Unfortunately, however, this is a very technical and costly procedure that not many surgical GYNs have experience performing. As a result, women needing to have the Essure device removed end up undergoing less effective and unnecessary surgeries.

If you are considering litigation, and you have a removal surgery scheduled or you are thinking about having a removal surgery, the micro-inserts and other specimens removed during the surgery are important pieces of evidence and so you must take steps to make sure they are preserved. Therefore, if you have an upcoming removal surgery scheduled, and you have not yet done so, it is very important that you contact your attorney, as soon as possible, so the necessary steps to have your device properly preserved can be taken. Prior to undergoing surgery to remove the Essure device it is also helpful to have a conversation with the surgeon who will be performing the operation. Questions to ask during this conversation include:

• Has either micro-insert migrated (moved from original implant site)? If yes, which side shows evidence of migration (right or left), and to where has it migrated?
• Is there any evidence of perforation (holes/punctures) caused by either of the micro-inserts? If yes, which side (left or right), and what was perforated?
• What is the planned approach for removal? In other words, what procedure does the surgeon plan to perform to remove the micro-inserts?
• Is the surgeon aware of the preservation request submitted by your attorney?

Likewise, questions to address with your doctor following surgery include:

• Where were the micro-inserts found within the body?
• Was there any evidence of migration? If yes, which micro-insert migrated (right or left), and to where had it migrated?
• Was there any evidence of perforation? If yes, which micro-insert had caused a perforation and what did it perforate?
• Were any unexpected findings encountered during surgery?
• What intra-operative testing was done to ensure all pieces of the micro-inserts were removed?
• What is the prognosis, including the likelihood of additional surgeries?

By inadequately warning about the difficult removal and improperly training doctors on the removal procedure, Bayer misled thousands of women and healthcare providers. Our experienced lawyers fight for individuals who have been harmed by defective products. If you or someone you know has suffered an injury because of Essure, or became pregnant while using the device, the attorneys at the Yost Legal Group may be able to help you obtain the compensation you deserve. For a free consultation, please call us at 1-800-YOSTLAW.