On July 20, 2018, Bayer announced that it will cease sales and distribution of Essure by the end of 2018 due to “business reasons.” The declining interest in Essure among women in the U.S. is what led to the decision; Bayer stands by the safety of its permanent birth control method. The announcement of discontinuation came after multiple FDA warnings of heightened risks and potential complications.
Over 750,000 women and their doctors have chosen to use Essure (based on units sold worldwide). There are currently over 18,000 lawsuits against Bayer and its implantation method of female sterilization, and bellwether cases are expected to begin in late 2019.
What is Essure?
Essure is a non-hormonal, permanent birth control option for women. It involves placing small metal and fiber coils in the fallopian tubes, creating scar tissue that prevents sperm from reaching an egg.
The non-surgical procedure can be completed in a doctor’s office in about 10 minutes, and women can return to daily activities the same day. The process is meant to be minimally invasive and requires no general anesthesia.
It can take three to six months for the Essure system to prevent pregnancy. Once fully effective, and assuming the coils are placed properly, the risk of pregnancy is supposed to be about 0.1 percent.
The device is meant to be permanent and cannot be removed without difficulty.
Potential Risks & Negative Impacts
As reported in clinical trials, here are some short and long-term risks to women using Essure.
Short-term risks include:
- Mild to moderate pain during and immediately following the placement procedure
- Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure
Long-term risks include:
- Abdominal, pelvic, or back pain
- Tear or hole (perforation) of the uterus or fallopian tubes
- Unintended pregnancy
- Allergy or hypersensitivity reactions
- Essure inserts unexpectedly moved to the abdominal or pelvic cavity
- If a patient and health care provider decide to remove Essure, another surgery may be required
History of Warnings
2002: Essure was approved by the Food and Drug Administration (FDA).
2011: Physician labeling was updated to substitute a warning for a contraindication related to nickel (current Essure labeling includes a nickel sensitivity warning).
2012: Patient and physician labeling was updated to include the results of a 5-year follow-up of subjects involved in clinical trials, as well as information on pregnancies that have occurred in the commercial setting (i.e. outside of clinical trials).
2013: Patient labeling was updated to include risks of chronic pain and device migration when using Essure.
February 2016: The FDA issued a new and mandatory clinical study by Bayer to determine increased risks for particular women using Essure. The goal was to help women and their doctors be better educated on the potential complications associated with implantable forms of sterilization.
October 2016: The FDA required a boxed warning be added to Essure device labels communicating the significant complications that can be associated. It also required a Decision Checklist with key items about the device, its purpose, and outcomes, in order to help patients and doctors make informed decisions as they consider permanent birth control options.
April 2018: The FDA restricted sales of the device as a result of over 26,700 complaints about Essure filed with the agency from 2002-2017.
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