Each day, another woman’s story emerges about Essure, a once-popular type of sterilization coil not just in the United States, but across the world. Just in the first quarter of 2017 alone, the United States Food and Drug Administration (FDA) has already been bombarded with some 2,000 claims of Essure complications. There have been a reported 9,000 removals of the coil since 2009.
Terrible Side Effects of Essure
According to the FDA, women have gone as far as having either fallopian tube removal or hysterectomies to remove Essure. Many had this done after experiencing severe abdominal pain and excessive bleeding after parts of the device broke off inside of them. Other women have reported having suffered fetal deaths or miscarriages.
Despite having been released in 2002, problems with Essure first started being publicized in 2013. The coil was initially marketed as a safe, less invasive alternative to a typical tubal ligation procedure. It was intended to be implanted in the woman’s fallopian tubes where scar tissue would form around it, making it impossible for eggs to pass through and be fertilized.
FDA Adds Risks to Essure Label
Just a year ago, in response to the many complaints about Essure that they’d received, the FDA decided to require Bayer, the coil’s manufacturer, to add additional known risks to the drug’s label, including organ perforation, chronic pain, and allergies. They also required Bayer to create a patient decision checklist to help patients decide if the risks outweighed the benefits for them.
More than 200 women have filed claims in the short time since the additional label was added to it. They have all argued that doctors failed to advise them of the known complications associated with the coil or that they failed to have them fill out the risk assessment checklist. As for Bayer’s response to criticism about Essure, they argue that all drugs and medical procedures carry with them inherent risks.
To date, Bayer has lost as much as $413 million in responding to thousands of lawsuits filed regarding Essure. It’s suspected that thousands more cases may be filed given that one million implants have been sold, mostly to U.S. consumers.
If you’re either currently suffering or formerly dealt with adverse side effects associated with your use of Essure, then you may benefit from discussing your right to join a class-action lawsuit against Bayer with a Houston defective drug attorney.
Source: The Philadelphia Inquirer, “Women harmed by sterilization coils push FDA to act,” Marie McCullough, accessed Aug. 18, 2017