The U.S. Food and Drug Administration is concerned that women are not as knowledgeable as they should be about the risks associated with permanent Essure birth control. The agency now recommends a black-box warning for the product along with a new patient checklist.
The New FDA Guidance on Essure Birth Control
The new guidance addresses hysteroscopically placed tubal implants. This type of implant is now linked to more than 300 fetal deaths and 5,000-plus adverse-events. Four women have allegedly died from use of the devices. Most of the complaints surround Essure birth control, marketed by Bayer.
“As the number of hysteroscopic sterilizations with such devices has increased, additional information, including reports of adverse events, has accumulated,” the FDA states in a document titled “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.” “This information has included reports of suspected hypersensitivity reactions to the implant materials, persistent pain, irregular vaginal bleeding, fallopian tube or uterine perforation, the identification of inserts in the pelvic cavity, and unintended pregnancy. Some instances of adverse events have resulted in surgical intervention, including device removal.”
Because of that, in September of 2015, the agency called on its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to convene with the goal of discussing mitigation strategies for Essure birth control. The FDA issued the guidance after it heard public comments on the issue.
Essure the Target of a Number of Lawsuits
The FDA’s actions are not binding or legally enforceable – yet. Notably, Essure is the defendant in more than one dozen personal-injury lawsuits in California, Idaho and Pennsylvania. Those cases stem from women who ended up with ectopic pregnancies, experienced pain in the abdomen and perforation of the fallopian tubes and found that the device had migrated to another part of their body. Bleeding and rashes are other symptoms.
“The agency strongly encourages healthcare providers to use the Patient Decision Checklist in discussions with patients considering Essure,” FDA spokeswoman Deborah Kotz told Modern Healthcare. She is referring to the product insert that includes verbiage as to the effectiveness, safety and use of the device. “The FDA is working with professional medical societies, patient advocacy groups and women’s health organizations to ensure that risk information about these devices is disseminated to patients considering Essure or other sterilization options.”
Checklist for Patient Knowledge
The FDA said the following items should appear on the checklist:
- Notification that permanent birth control is irreversible;
- Notification that the device might be ineffective and result in unintended pregnancies;
- Notification of the types of complications associated with the device; and
- Notification of the materials used in the device and related allergies or hypersensitivities.
Both the patient and physician should sign the checklist acknowledging they have read the material.
“The FDA also encourages device manufacturers to develop a plan to audit (and if appropriate, institute steps to improve) the distribution and signing of the checklists as a component of the patient decision-making process, and to periodically update the checklist as additional data is collected with post-market experience,” according to the agency.