FDA Mandates Addition Of Black Box Warning On Bayer’s Essure Permanent Birth Control
The FDA is requiring the drugmaker to conduct a new clinical trial for Essure, to identify which groups of women might have an increased risk of side effects.
March 4, 2016 | by Sarah Massey, M.Sc.
In an effort to ensure physicians and patients are aware of the potential complications of using Bayer’s Essure – an implantable form of permanent birth control – the US Food and Drug Administration (FDA) is calling for a change in the product’s labelling. In addition, the FDA is requiring the drugmaker to conduct a new clinical trial for Essure, to identify which groups of women might have an increased risk of side effects.
The agency will require Bayer to add a black box warning to the device packaging, as well as provide a patient decision checklist meant to help women fully understand all of the benefits and risks of using the device. Since Essure was approved over a decade ago, the FDA has continuously monitored both the safety and effectiveness data on the device by evaluating the medical journal articles, clinical trials and post-approval study data.
“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,” said Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Essure – which was promoted as an alternative to tubal ligation sterilization – has been linked to a number of adverse events, such as persistent pain, device migration and uterine perforation, since its launch in 2002. The device uses flexible coils that are inserted into the fallopian tubes; scar tissue begins to form around the device over a period of approximately three months.
This scar tissue acts as a physical barrier to prevent fertilization of the eggs. Women with an implanted Essure device are required to use an alternate form of birth control while the scar tissue is still forming.
The FDA maintains that Essure is still a viable permanent birth control option for most women, however some patients are at an increased risk of developing complications following insertion of the device. These potential complications for a subset of patients prompted the FDA to release draft guidance on the risks associated with permanent hysteroscopically-placed sterilization devices.
The mandatory black box warning for Essure will need to include a list of adverse events that have been associated with the device, along with risks linked to insertion and/or removal procedures. The patient decision checklist will not only ensure that patients are aware of the risks of the device, but will also stress the importance of the confirmation test which is performed three months after implantation to make sure the scar tissue has formed properly, and will be able to prevent conception. The FDA will require the checklist to be signed by both the patient and physician prior to performing the insertion procedure.
The postmarket surveillance study to be conducted by Bayer, will provide a real-world view of the risks associated with Essure when compared to laparoscopic tubal ligation. The drugmaker will be required to study rates of unplanned pregnancy, pelvic pain, and how often patients undergo surgery to remove the device. The FDA says this data will help them decide whether further actions are necessary to regulate Essure and protect public health.
Keywords: FDA, Medical Device, Postmarket Study
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