FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts.
“Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an April 20 blog post.
Essure is a small metal coil that is implanted in the fallopian tubes via catheter. In 2015, FDA reported that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device. There were also complaints of the device breaking, and more than 1,000 unplanned pregnancies. In addition to 5 fetal deaths, there were 4 reports of adult deaths caused by infection and uterine perforation, FDA said. However, FDA has stated that it believes the benefits of the device outweigh its risks, and that updated labeling helps to ensure that women are appropriately informed of the risks.
Due to these serious patient complaints, the product has become a high-profile target for litigation as well as FDA scrutiny. In October, 2016, FDA issued final guidance recommending more aggressive labeling, by way of a black box warning and a decision checklist.
Boxed labeling was required to display significant or common adverse events associated with the device and its application, including those from clinical trials or other device use experience. Labeling also included a statement noting that “these risks should be conveyed to the patient during the decision-making process.”
A required checklist outlined key risk and benefit information about the device and procedure, including detailed probability rates for events within individual checklist items
However, based on Ennis’s analysis, the guidance reveals gaps in FDA’s ability to ensure that patients will actually see these warnings. “Physicians are not ‘required’ to advise patients of the black-box warning, nor provide the patient-decision checklist to the patient,” Ennis said.
Ennis has long been critical of the device and of FDA’s response in meeting safety and efficacy standards, arguing that “the warning falls woefully short,” in addressing a host of other severe complaints such as chronic inflammation, foreign body reactions, increased risk of cyst development, and chronic headaches.
FDA will continue postmarket surveillance from a variety of sources to monitor safety and effectiveness of Essure.
Associate editor Fink Densford contributed to this article
[Want to stay on top of MDO content? Subscribe to our weekly e-newsletter.]
