“The FDA is also increasing its scrutiny of nitinol. Last August, a law firm in Australia launched a class action lawsuit on behalf of patients alleging that their Essure implants corroded and caused them to suffer nickel poisoning.” (https://www.icij.org/investigations/implant-files/us-to-investigate-health-impact-of-nickel-silicone-in-medical-implants/).
“Essure is a permanent sterilization device intended for women who have decided against any, or any more, pregnancies. The aim of the permanent implant is to trigger tissue growth that blocks the fallopian tubes and prevents sperm from entering the ducts.” (https://www.medpagetoday.com/washington-watch/fdageneral/77134). “Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.” (https://www.neuralit.com/mass-torts/devices/essure).
“In an official posting, FDA Commissioner Dr. Scott Gottlieb said the FDA is working with Bayer to “revise and strengthen” its post-market study of Essure, which was ordered by the federal watchdog in 2016. The trial will now follow patients who received the Essure device for five years rather than the initially requested three years, giving the agency “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” Gottlieb wrote in the posting.” (https://www.massdevice.com/fda-updates-on-post-market-study-revisions-oversight-for-bayers-essure/). “On April 9, 2018, FDA restricted the sale of 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”. In July 2018, Bayer announced Essure would be wiped out of the market by December 31, 2018.” (https://www.neuralit.com/mass-torts/devices/essure).
“There are also currently over 16,0000 lawsuits alleging harm caused by Essure. There are serious concerns regarding the approval process of the device along with the post-approval studies, and a current study ordered by the FDA. Patient activist groups, such as the Essure Problems Facebook group, have created platforms for support and education. Before making your decision, you should consult your doctor and make sure to ask a lot of questions, such as… Why are you recommending this product after Bayer has announced pulling it from the market? How many of these procedures have you done? Do you have a copy of the current patient checklist we are mandated to review and the black box warning we can discuss? What is your failure rate in placing Essure correctly in one attempt? Do you use general anesthesia to place Essure, or will I be awake the entire time? Have you ever removed essure? If so, how?” (https://www.nwhn.org/bayer-has-recently-announced-they-will-remove-essure/).
If you, a family member, a loved one, a friend, or anyone you know is experiencing problems with an Essure device, it may be time for you or that other person to contact a lawyer. There are statutes of limitations (deadlines), so waiting too long can mean no case. Paul J. Molinaro, M.D., J.D. offers free consultations on Essure cases for patients who reside in California.