On April 9th, the U.S. Food and Drug Administration (FDA) restricted the sale and distribution of the Essure permanent birth control device. In its media release, the FDA reports that it was aware that some women have received the Essure birth control device without also receiving adequate information about the device’s risks. Now, the FDA is restricting the sale of Essure to ensure that only healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist–Acceptance of Risk and Informed Decision Acknowledgement” documents are allowed to implant the device. Doctors and other healthcare providers must review this document and checklist with the patent, and both parties must sign the documents indicating they are aware of the risks of having the device implanted. The FDA also required that Bayer Pharmaceuticals, the manufacturer of Essure, revise the warning label to include the requirement that the healthcare provider and patient read and review the documents and sign them before using the device.
What is Essure birth control system?
Essure is an implanted permanent contraceptive device that received premarket approval by the FDA in 2002. Originally manufactured by Conceptus, Bayer Pharmaceuticals purchased Essure in 2013.
The Essure birth control device is constructed of two thin, flexible metal coils about the length of your little finger. The healthcare professional implants these coils into each fallopian tube of a woman’s body. This device is designed to create scar tissue within the fallopian tubes, which is supposed to block fertilization from occurring.
What adverse effects have women experienced with the Essure birth control device?
Some of the problems with the Essure device include injuries when the implant breaks apart and migrates throughout the abdominal cavity, perforations of the fallopian tubes or uterus, and severe abdominal pain and heavy bleeding. Other adverse effects and injuries from Essure include:
The FDA recommends that doctors and healthcare providers thoroughly discuss the various sterilization and birth control methods available with their patients, making them aware of the benefits and risks of each option. Consumers are also encouraged to report any adverse events or side effects from using Essure to the FDA’s MedWatch Safety Information and its Adverse Reporting Program.
Anyone who is experiencing adverse effects from the Essure birth control implant should contact McGowan, Hood & Felder, LLC to discuss legal options with an experienced defective medical device attorney.
At McGowan, Hood & Felder, LLC, we are dedicated, driven, and committed to delivering results for our clients. You may contact us by calling 803-327-7800 and scheduling a free case evaluation by a defective medical device attorney or by filling out our contact form now. We proudly serve people throughout South Carolina and assist with cases throughout the nation.