Although no formal decisions will be made at Thursday’s meeting, the experts will consider whether or not to require a warning label on the product and if more clinical studies are needed to ensure the safety of the device.
This is a big week for celebrity activist Erin Brockovich. On Tuesday, the same day that members of Congress introduced legislation to compensate the Navajo Nation for the Gold Creek EPA mine spill that Brockovich raised awareness for earlier in the month, the U.S. Food and Drug Administration (FDA) released to the public the questions to be reviewed in Thursday’s risk assessment of the controversial birth-control device, Essure. Brockovich began the social forum “Essure Procedure” in 2013, and has been advocating against the device that is sold by Bayer, who bought the rights to Essure from Conceptus in 2013. Currently, the Facebook group “Essure Problems” has over 17,000 members, the largest among several social outlets involving the drug, with the FDA noting that the amount of people publicly objecting to the device is what prompted the review. In a statement, the agency wrote, “The FDA takes reports of safety concerns seriously. Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement.”
Like many other women in the group, administrator Angela Lynch has experienced pain, fatigue, heavy bleeding, as well as skin allergies that she attributes to the device. The 28-year old Lynch describes her experience with the product, “Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust. After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.” Lynch had the device removed in 2012 along with undergoing a hysterectomy, describing the experience, “After three days it was like I woke up from a 5-year flu.” Dr. Karen Ashby, an OB/GYN at University Hospitals Case Medical Center says that the device is difficult to remove and that along with itchy skin, “Some of the big things I’ve seen in my patients is pain. There’s always a possibility that they’re allergic to the metal.” Although no formal decisions will be made at Thursday’s meeting, the experts will consider whether or not to require a warning label on the product and if more clinical studies are needed to ensure the safety of the device.
Indiana OB/GYN Dr. Cindy Basinski, a consultant for Bayer will be testifying that “anecdotal” information should not override scientific conclusions; however she says that she “no way discounts the patients out there recounting their experience.” Bayer representatives note that clinical trials were performed on over 10,000 women before its FDA approval. Dr. Basinski claims that she has performed about 1,100 procedures since the device was approved in 2006, with only “a couple” of patients asking for the device to be removed. Removal is another issue that concerns doctors like Shawn Tassone of Austin, Texas, who notes that there is no standard procedure for removing the Essure implants. Tassone said about the upcoming review, “I’m hoping that all this will change the way doctors counsel their patients,” Tassone said. “Instead of saying Essure is an easy procedure with no side effects, say this is a surgery and there are people reporting complications.” Bayer’s medical director for Essure Patricia Carney said that the company is receptive to the risk-assessment, telling Reuters, “We want to understand as a company what is going on. We want to know whether there is a link to the product.”
(Correction) Angela Lynch is the Facebook site “Essure Problems” administrator, Angie Firmalino is the group’s founder.
ABC News – Gillian Mohney
HNGN – Suzette Gutierrez
Reuters – Toni Clarke