FDA Announces Label Changes for Essure Permanent Birth Control System
Essure is preferred by many women as a form of permanent birth control because, unlike tubal ligation, no surgery is required. To insert the Essure device only takes about 10 minutes and can typically be performed in a doctor’s office. The Essure device consists of tubal implants which prevent pregnancy. Women have opted for this permanent birth control solution due to the minimal downtime required; most women can resume their regular schedule within two days.Whether a woman uses tubal ligation or Essure tubal implants as a form of permanent birth control, it’s important that she knows what to expect before, during and after the procedure. A woman should fully understand the benefits and risks of any form of birth control. The Food and Drug Administration (FDA) believes that some women did not previously receive complete and accurate information about the risks and benefits associated with use of the Essure tubal implants.
Now, Bayer Healthcare, the manufacturer of Essure, has recently updated the labeling for this product. Essure now includes a boxed-warning and Patient Decision Checklist to be used by gynecologists when discussing whether or not Essure is the right choice for a patient. Both documents are intended to be used during patient counseling to help patients better understand how the Essure birth control device works. Health Canada, the Canadian counterpart to the FDA, earlier added a boxed-warning to the Essure product.
The boxed-warning includes information about side effects and adverse outcomes that may warrant the device’s removal. In the past, some patients had experienced pain, allergic reactions and perforation of the uterus. The boxed-warning also includes information about benefits and risks associated with the Essure device.
The Patient Decision Checklist provides important information about Essure tubal implants and is to be used by the patient and her physician to discuss key elements of the device prior to its insertion. The items to be discussed include the following:
* Notification that Essure is permanent in nature and cannot be reversed
* Recognition of all alternative methods of birth control, as well as their overall effectiveness and safety
* Discuss the chances of becoming pregnant
* When the device should not be used
* Types of side effects and adverse events
* Symptoms to look for that may signal complications
The end of the checklist includes signature lines for both the patient and physician. Requiring the signatures is intended to certify that the patient has been informed about and understands the benefits and risks associated with use of Essure. Further, the signature is intended to indicate that the patient has been advised that the opportunity to become pregnant no longer exists once Essure tubal implants are in place.
The lawyers of Nadrich & Cohen, LLP have handled many birth control dangerous side effect lawsuits, including Yaz, Yasmin, Ocella, Ortho Evra and more. We are now actively investigating Essure tubal implant injuries. If you believe that you or a loved one may have an Essure lawsuit claim, call today for a free, confidential consultation.