The Food and Drug Administration, FDA, plans to restrict sales of Essure, birth control device. The device, sold by Bayer, has suffered a 70% decline in sales, with shareholders expecting sales to fall further following the announcement.
Sale restrictions for Essure first came in April, with warnings that the potentially dangerous device was still being implanted in women without them being fully informed of the potential risks. The FDA claims that many women have received Essure without being informed of the device’s risks. The agency will only allow healthcare providers to offer the birth control device if they review and sign a checklist before the device is implanted.
Bayer has been required to create a patient-doctor checklist after thousands of complaints prompted Essure recalls. The risks of the device are severe, with the device causing dozens of side effects, including potential perforation of the organs, migration, breakage and abdominal pain. Unintended pregnancy has also been noted with Essure.
The FDA’s checklist requirement is in place to protect patients and ensure that they receive the complete list of risks and concerns associated with having Essure implanted. Black Box Warnings have also been introduced. The warnings are the industry’s strongest, with the only other punishment being a device recall.
Bayer has also been required to perform additional studies to demonstrate the safety and effectiveness of Essure.
Legal professionals note that the intervention from the FDA does little for a person that has been harmed by the Essure device. Legal experts recommend seeking a lawsuit against Bayer when a woman has had the birth control device implanted without being properly warned about the potential side effects and complications.
As of December 2017, there were 26,773 adverse Essure events reported to the FDA. Women complain that the device, which often breaks inside, leaves fragments that cause chronic pain and discomfort.
Bayer, which still claims that the device is safe, also suggests that there’s no way to tell which women will suffer from complications. Women that have suffered from complications state that every aspect of their lives is affected following Essure complications.
Bayer claims that Essure is “surgery free, hormone free and worry-free.”
Women have suffered from pain that is so debilitating that it leads to missed work and very heavy, painful periods. Many women have such severe side effects that a hysterectomy needs to be performed to stop the pain.
Bayer representatives claim that they take all claims “very seriously.”