Recently, the US Food and Drug Administration (FDA) announced that it will require a new study and a black box warning label for Bayer’s permanent birth control device Essure after thousands of women complained about suffering complications from the controversial implant. 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.
The new study will require Bayer to design and conduct a large observational group 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 outline within 30 days and must begin the study within 15 months. There are several things FDA wants Bayer to look at including: (1) the rates of complications, including unplanned pregnancy, pelvic pain and other symptoms to evaluate the device’s impact on quality of life; (2) examine why some patients did not receive their three month follow up confirmation; (3) and study surgical procedures to remove Essure, which, up till now have not been studied.
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.”
Guidance and Boxed Warning
In addition, the FDA gave a suggestion for 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 reason for the suggestion and not requiring the black box warning immediately was to allow for public comment to get input from stakeholders, including women who have experienced problems with the device. The proposed language of the boxed warning is below:
Black box warning essure
The draft guidance also recommends a “patient decision checklist” that calls for physicians to inform patients that Essure is intended to be permanent and discuss alternatives,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 suggests 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.
The 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 including pelvic pain, stomach swelling, dizziness, cramping, bleeding and fatigue. 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.”
Bayer has maintained that Essure, which the FDA approved in 2002, has a solid safety record and should remain available as an option to women seeking permanent birth control. The company vowed to work with the FDA to put the agency’s recommendations in place.
The agency said Monday it will seek public comment on the new recommendations for 60 days.
– See more at: http://www.raps.org/Regulatory-Focus/News/2016/02/29/24423/[Update]-FDA-New-Postmarketing-Study-Black-Box-Warning-for-Essure/#sthash.wO8WYtgB.dpuf & https://www.washingtonpost.com/news/to-your-health/wp/2016/02/29/fda-requires-black-box-warning-but-leaves-controversial-essure-implant-on-market/
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