Instead of Taking Dangerous Birth Control Device Off Market, FDA Adds a Warning Label

Cortney O'Brien
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Posted: Jun 30, 2015 1:00 PM
Instead of Taking Dangerous Birth Control Device Off Market, FDA Adds a Warning Label

"These symptoms, these problems are not in our heads," said Essure user Claudia Castellanos. "They are real. Our pain is real." 

A birth control method called Essure has prompted serious side effects such as hair loss, debilitating pain and constant bleeding and has even been associated with five deaths, reports MyFoxDC. Because of the unwanted threats the device poses, women fully expected the U.S. Food and Drug Administration to take it off the shelves when they voiced their concerns. The government agency had other plans: a public hearing in September and a warning label will suffice.

MyFoxDC first reported on Essure’s dangerous side effects in November. Here were a few of their unnerving findings:

But more than 10,000 women are accusing the maker of an implantable birth control device of ignoring complaints from users that the product was unsafe, even before it was approved by the FDA . The women claim they've had perforated organs, chronic pain, excessive bleeding, pain and other adverse side effects from the device. Some report they've been forced to have hysterectomies to solve the problems.

At the time, Bayer, the company that produces the birth control device, dismissed these concerns as what’s to be “expected.” So uncontrollable bleeding and chronic pain are totally normal when using Essure? How comforting.

Now, months later, as the complaints persist, Bayer has offered another not so reassuring statement regarding the drug:

“Patient safety is Bayer's top priority. Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.

Well-founded fear over a product’s safety is defined down by Bayer to “a great deal of interest.”

MyFoxDC spoke to three women, Claudia Castellanos, Ana Fuentes and Janet Ramirez, who were victims of Essure's painful side effects, and who now call themselves The Essure Sisters, holding rallies in protest of the device and writing to the FDA. Ramirez offered an especially emotional plea to the agency:

"Listen to the evidence and please, please remove this off the market," she said. "It is not safe." 

Despite what Bayer says, this is not just a time for “discussion.” This dangerous situation demands action. Until Bayer and the FDA at least figure out what’s causing these threatening and sometimes deadly side effects, they need to pull the product before even more damage is done.