Bayer announced this month that it would halt sales and distribution of its controversial birth control implant device, Essure, after December 31st, 2018. The decision follows a years-long debate over the safety and effectiveness of the product, a permanent form of birth control for women ages 21-45. Essure consists of two soft, nickel-titanium coils that are placed into the fallopian tubes. The device is designed to trigger an inflammatory response that creates scar tissue around the coils, thereby preventing pregnancy by blocking the fallopian tubes.
Although pharmaceutical giant Bayer stands behind the safety of the device, criticism has continued to increase after it was the subject of almost 17,000 lawsuits or claims filed by American women who reported suffering serious complications from using Essure. Since first approving the implant in 2002, the U.S. Food and Drug Administration (FDA) has received nearly 27,000 reports from users and physicians with accounts of health problems and injuries they say were caused by the device, including:
- Chronic pain
- Abdominal pain
- Heavier menses
- Menstrual irregularities
- Weight changes
- Hair loss
- Mood changes (including depression)
- Allergy or hypersensitivity reactions
- Joint or muscle pain
- Muscle weakness
- Migration of the device or device components
- Dislodged or dislocated device
- Device breakage
- Perforation of the uterus or fallopian tubes
In 2016, the FDA ordered that a post-market study be conducted on Essure’s safety, as well as an update to the device’s label to include a black box warning and a Patient Decision Checklist “to ensure patients are well-informed of risks before choosing a permanent birth control method,” the agency’s website states. In 2018, with an estimated one million units of Essure sold worldwide, FDA regulations were increased again: Bayer was required to restrict its sales of Essure only to doctors and hospitals that follow FDA-approved protocol for properly informing patients and obtain their signature before implanting the device. Bayer is now pulling the device from shelves by the end of this year after sales have reportedly dropped by 70 percent since the agency stepped up informed-decision standards for patients considering Essure.
If you have used or are currently using Essure, you should immediately discuss the health risks with your doctor. Do not make a decision to discontinue use until you have discussed the health risks and benefits of doing so with your physician or healthcare provider.
Florin|Roebig is currently accepting Essure injury cases from patients throughout the United States. If you or someone you love has been injured as a result of using Essure, you can contact the attorneys at Florin|Roebig for a free case evaluation and consultation by either calling (800) 226-6581 or by completing and submitting a case review form.