Bayer, the manufacturer of Essure, will stop marketing and won’t be selling the permanent birth control device in all countries except for the United States. They insist it was just for lack of interest and low profits in other countries and not due to the tens of thousands of injuries women experienced while using the device. But, why is it still safe for women in America?
Essure & The United States
Bayer’s decision comes after Brazil, Canada, Australia, and the European Union refused to have Essure still sold in their countries. Unfortunately, in the U.S. it is all about profit. The FDA is supposed to protect our nation’s health, but it isn’t standing up to Bayer. Last year, the agency told Bayer to put a Black Box warning on the device. This is the strongest warning a product can have. However, the warning is useless if women never see the labeling. Plus, no one is properly educating doctors on the risks of Essure. Bayer is educating medical personnel and giving them pricey medical equipment for purchasing two Essure kits per month.
They also aren’t making a huge profit here either. In 2016, Bayer lost over $400M due to injuries caused by the device. Almost 10,000 women filed complaints with the FDA due to horrific side effects they experienced when using the device. This led to thousands of lawsuits against the manufacturer.
Essure Injuries
Essure is a permanent birth control options, which uses two nickel-titanium coils placed inside the fallopian tubes. The coils spur scare tissue that eventually blocks the tubes to prevent pregnancy.
In 2002, the FDA fast-tracked the device, but they required researchers to monitor patients in the initial study for an additional 5 years. Regrettably, researchers followed only 366 of the original 618 patients. Out of those 366, 15 had hysterectomies, 38% had usually heavy periods, 5% suffered from recurrent pelvic pain and 4% painful intercourse.
The most common complications are pregnancy (nearly 1 in 10 women are at risk), hysterectomy, allergic reaction, and abdomen or pelvis perforation.
According to the FDA’s website, the agency continues to monitor the safety of Essure and believes that “the benefits of the device outweigh its risks.”
In an emailed statement to CBS News, the agency said it is aware that Bayer is no longer marketing Essure in any countries except for the U.S.
“The FDA has taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device,” the agency said.
We Want to Help Essure Victims
It is your right for manufacturers to inform you about the long-term risks associated with the medical devices. Additionally, it is the responsibility of manufacturers to provide this information. If you or a loved one has suffered any side effects from Essure, you should demand accountability from Bayer. Why did no one tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products. Likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal. As well as for your physical and emotional suffering. There is no obligation.