Essure became available in the US in 2002 but it wasn’t until over a decade later complaints about the device began catching the attention of the Federal Drug Administration (FDA). From relatively few complaints submitted to the FDA in previous years, the number of complaints increased so dramatically from 2014 (1,788) to 2017 (12,564) that the FDA insisted on restricting sales of the device. In 2018, after pressure from the FDA and declining sales over the previous two years, manufacturer Bayer announced it would no longer sell Essure in the US – the only country where the device was still being sold.
The Los Angeles Essure lawsuit attorney at Law Offices of Howard Craig Kornberg knows the product and the injuries it can cause. Our legal team has the expertise to help you recover from injuries from your Essure device.
How the Essure Birth Control Device Works?
The Essure device is a two-inch metal coil. Going through the cervix, one gets inserted in each fallopian tube. The device is supposed to prevent pregnancy by causing a build-up of scar tissue that makes it unlikely an egg and sperm will be able to meet. Essure was the only non-surgical, permanent birth control available in the US.
Problems with Essure Birth Control Device
The problems reported from women using the device included some mild symptoms right after insertion to more serious complications that developed over time. Of the 63,942 ‘adverse event’ reports received by the FDA between November 2002 and December 2020, 58.5% were for pain/abdominal pain and 27% were for menstrual irregularities and heavy bleeding.
- Pelvic pain and cramping
- Vaginal bleeding
- Nausea, vomiting
- Headaches, dizziness
- Chronic pain – abdominal pain
- Heavy or irregular periods
- Autoimmune reactions such as fatigue, weight gain, and hair loss
- Allergies to the metal device
- Device dislodged or migrated
Once inserted, Essure is designed to be permanent and removal of the device requires surgery. The surgery can be relatively simple or result in complications that require a hysterectomy.
Of the over 17,000 adverse event reports received by the FDA in 2017 and 2018, 85% included information regarding a device removal. Only about 6,000 of the reports contained information about a patient’s outcome after removal and over 50% of those indicated only partial improvement or no improvement of their symptoms.
Bayer’s Response to Mounting Injury Claims in the US
In August of 2020, Bayer announced it had reached an agreement with the attorneys for about 90% of the 39,000 US claims alleging Essure device-related injuries. Bayer’s announcement came on the heels of documentation showing there was ‘systemic’ underreporting of Essure injury complaints to the FDA.
The settlement covers both filed and unfiled cases and participation in the settlement requires that a case be dismissed or not filed. Bayer will pay $1.6 billion without admission of liability or wrongdoing. The company continues to stand by the ‘safety and efficacy of the Essure device.
Essure is no longer being sold but women still have the devices and complaints of related injuries continue to be made. If you have an Essure implant and are having problems you believe are related to the device or you had the device removed because of problems, the Law Offices of Howard Craig Kornberg can help. The legal theories for establishing liability and the injuries to women from the device are well documented. Our Los Angeles Essure lawsuit lawyer can review your case and determine whether an Essure lawsuit can compensate you for your injuries. You may contact our legal team to schedule a free consultation by clicking here or calling our office at 310-997-0904.