This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement.
After months of deliberation, the US Food and Drug Administration (FDA) announced on Monday that it will require a new postmarketing study and a black box warning label for Bayer's permanent birth control device Essure.
Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pair of nickel-titanium coils that are inserted into the fallopian tubes, prompting scarring which physically blocks a woman's eggs from being fertilized.
FDA says it will require Bayer to design and conduct a large observational study enrolling at least 2,000 patients over a period of three years, comparing patients with Essure and patients who underwent tubal ligation to identify the risks to women posed by the device. FDA says Bayer must submit its study design within 30 days and must begin the study within 15 months.
In August, a study appearing in The BMJ found that women who underwent hysteroscopic sterilization with Essure were ten times more likely to undergo reoperation compared to women who had tubal ligation.
FDA says Bayer must also study the rates of complications, including unplanned pregnancy, pelvic pain and other symptoms to evaluate the device's impact on quality of life. The agency also said it wants Bayer to examine why some patients did not receive their three month follow up confirmation.
During a press call with FDA, William Maisel, chief scientist at the Center for Devices and Radiological Health, said that FDA examined more than 600 reports of pregnancies related to Essure, which resulted in nearly 300 terminations for various reasons. According to Maisel, the "lack of an Essure confirmation test is most common factor contributing to unintended pregnancies in women with Essure."
Additionally, FDA says Bayer must study surgical procedures to remove Essure, which, up till now have not been studied.
The agency says it will use the results of the study to guide any further actions related to the device.
Guidance and Boxed Warning
In a draft guidance released alongside the announcement, FDA said it will require a black box warning on Essure's label, warning patients of reported complications such as perforation, device migration and allergic reaction to materials in the device. The proposed language of the boxed warning is below:
The draft guidance also recommends a "patient decision checklist" that calls for physicians to inform patients that Essure is intended to be permanent and discuss alternatives, contraindications and significant adverse events related to the device.
FDA says that both physicians and patients should sign an acknowledgement they have reviewed the checklist and encourages device makers to "develop a plan to audit the distribution and signing of the checklists as a component of the patient decision-making process."
"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," Maisel said.
Rather than requiring the black box warning immediately, Maisel said the agency decided to issue the recommendations as a draft for public comment to get input from stakeholders, including women who have experienced problems with the device.
Monday's announcement comes as a result of FDA's second review of Essure since its approval in 2002. In 2013, an FDA review found the device to be an effective alternative to surgical sterilization options.
FDA says it made its decision based on recommendations from its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee and a review of adverse events and medical literature related to the device.
During the call, Maisel also dispelled allegations of clinical trial misconduct by Conceptus, Essure's original manufacturer, saying FDA examined "more than 100,000 data points associated with key safety and effectiveness measures. In the end, our analysis did not find evidence of systematic or intentional modifications of study subject responses. The agency believes the original clinical data … represents valid scientific evidence."
Reactions to FDA's Announcement
Many of the complications that drove FDA to re-evaluate the device came to light after the Facebook group Essure Problems began raising awareness about serious side effects.
Essure Problems, which now has more than 27,000 members, has called on FDA to revoke Bayer's premarket approval (PMA) for the device. In addition, two congressmen have been vocal about their interest in having the device pulled from the market by FDA.
In a statement released today, the administrators of the Essure Problems group called for FDA to revoke Essure's PMA, saying:
"We are outraged that … FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies … We have provided the FDA with enough relevant data to prove that Essure is unsafe … We will not be stopped nor silenced."
Representative Mike Fitzpatrick (R-PA), who is sponsoring a bill that would order FDA to revoke Essure's PMA, said it is "unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market … If the FDA is going to order another study, then at the minimum they should take Essure off the market during that time."
When reached for comment, Bayer said it will "continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure."