After a  six-month-long review, the FDA has decided that a new “black box” warning should be placed on Bayer’s controversial birth control product, Essure. The FDA has also “ordered” Bayer Pharmaceuticals, Essure’s current manufacturer, to conduct a new study on the device’s “real-world” risks, CNN reports.

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Black Box Warning For Essure

sick pregnant woman

In a press release dated March 1 (published, perhaps accidentally, on February 29, 2016), the FDA announced it was “recommending” product labeling revisions “that will help to communicate to health care practitioners and patients the potential serious complications that can occur in some women.”

William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said:

“the actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them.”

The new label will be augmented by a “boxed warning” listing the many adverse events that have been associated with Essure. A full text for the FDA’s proposed warning has not yet been released, and the agency’s press release has been taken off its website for the time being. The URL hosting the FDA’s most recent announcement on Essure now redirects to “Page Not Found”:

 

Update April 5, 2016 – FDA Releases Proposed Essure Warning, Patient Decision Checklist

After several days in digital limbo, FDA released a wealth of documents specifying changes the agency intends to make to Essure’s warning label. In a “Draft Guidance” published on March 4, 2016, the agency presented the public with its first look at a proposed “black box warning,” meant to be printed on all “physician and patient labeling materials” related to the birth control implant. Here’s the text, which at this point is FDA’s suggested language, and may change after review by Essure’s manufacturer:

“WARNING: Some patients implanted with the Essure system for Permanent Birth Control have reported adverse events, including perforation of the uterus and / or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery. This information should be shared with patients considering sterilization with the Essure device during discussion of the benefits and risks of the device.”

Interestingly, while the proposed text itself specifies Essure, the guidance document’s recommendations explicitly pertain to all “hysteroscopically-placed tubal implants for sterilization.” Currently, Essure is the only available that fits that description, but the FDA is likely anticipating new technologies, which work in similar ways, to enter the market in the future. The general nature of FDA’s language may also be intended to cover patients who had Adiana, a tubal sterilization implant no longer on the market, implanted in the past.

Patient Decision Checklist

Accompanying Essure’s proposed “black box” warning is the “patient decision checklist,” a document that will be included in labeling brochures for patients. The checklist will list 14 items, with sections notifying prospective patients that:

  1. Essure is permanent
  2. other “highly effective,” but non-permanent forms of birth control are available
  3. other permanent sterilization procedures are available
  4. some women, including patients who believe they may be pregnant, are not appropriate candidates for Essure
  5. successful implantation may not be possible for all women
  6. Essure is not immediately effective. Patients should use an alternative form of birth control until the implants’ functioning has been confirmed. Patients should undergo a confirmation test 3 months after their implantation procedure.
  7. even after a confirmation test, a “physician may inform [patients] that [they] may not be able to rely on the Essure System for permanent contraception.” In that case, an alternative form of birth control will be required to prevent pregnancy.
  8. no form of birth control is 100% effective.
  9. the risks of Essure to a developing fetus have not been established.
  10. side effects have been reported during and immediately after the Essure procedure, including cramping, mild to moderate pain, nausea and / or vomiting, dizziness and / or lightheadedness and vaginal bleeding.
  11. some women experience adverse side effects after being implanted with Essure, including persistent pain, device puncture of the uterus and / or fallopian tubes or movement of the device into the abdomen or pelvis. Allergic reactions have also been reported. Women should contact their physicians after experiencing abdominal, pelvic or back pain, symptoms consistent with an allergic reaction, joint or muscle pain, muscle weakness, excessive fatigue, hair loss, weight changes and mood changes.
  12. Essure implants contain certain metals, including nickel, titanium, iron, chromium and tin, along with polyethylene terephthalate (PET). “Some women may develop allergic or hypersensitivity reactions to the device following implantation, even if they have no prior history of sensitivity to those materials.”
  13. after placement, the implants can move in some patients.
  14. removing the Essure implants, requires a surgical procedure, and potentially, a hysterectomy.

After reading each individual item, a patient will sign with their initials. At the bottom of the document, both patients and physicians will sign in full, acknowledging that they have discussed the benefits and risks of Essure.

After releasing its Draft Guidance, FDA set up an open docket on Regulations.Gov, allowing members of the public to comment on the proposed changes. To date, 649 people, mainly current and former Essure patients, have added their suggestions and concerns. Mirroring a wider debate, many commenters suggest that the strengthening of warning labels doesn’t go far enough, and advocate for a total recall instead.

FDA Recommends Risk Consultation “Contract”

The FDA has also suggested a “patient decision checklist” to help guide doctors as they consult women on the implants. The checklist will reportedly highlight the potential risks of Essure, and stress the importance of undergoing a “confirmation test three months after the device is implanted.”

This test, called a hysterosalpingogram, is used to make sure the implants are correctly blocking the Fallopian tubes, but follow-up reports have found that it is not always administered to patients.

The FDA recommends that both patients and physicians complete and sign the proposed checklist, before proceeding with the implantation procedure.

“Real-World” Risk Study Ordered

Bayer has been ordered to perform a new “postmarket surveillance study,” created to gather data on Essure’s side effect risks “in a real-world environment.” Public health advocates have criticized the validity of Bayer’s initial clinical trials.

The new study, according to FDA, will compare the risks of Essure to those presented by tubal ligation, the standard method for permanent female sterilization. The agency highlighted specific risks of note, including:

  • unplanned pregnancy – Essure has been advertised as highly effective, far more so than tubal ligation. Several recent studies, however, have found evidence to the contrary. As just one example, a study published in April 2014 by the journal Contraception found that the risk of becoming pregnant was more than 10 times higher over a 10-year-period for women who had undergone “hysteroscopic sterilization” procedures, like Essure, than traditional tubal ligation.
  • pelvic pain, by far the most commonly-reported Essure side effect
  • surgeries to remove the Essure device” – Hundreds, if not thousands, of women have chosen to undergo invasive hysterectomy procedures, rather than continue living with the side effects they attribute to Essure. To date, removal surgeries for Essure have not been studied, according to the Regulatory Affairs Professionals Society.

Notably, the study won’t just record how many women experience these complications. It will also attempt to evaluate “how much these complications affect a patient’s quality of life,” the FDA writes.

The FDA said it will use the new study’s results in considering further regulatory action.