Essure is a permanent method of birth control that works by inserting metal and polyester coils into the Fallopian tubes. Scar tissue forms around the coils, blocking sperm from reaching and fertilizing the egg. Because the insertion is done non-surgically through the vagina and cervix, only minimal anesthetic is needed for the procedure and it can be done in approximately ten minutes. Although Essure has been promoted as an easy method to preventing pregnancy, many women who have been implanted with the device have suffered severe side effects as a result of its use.
Side Effects and Problems with Essure
The Essure birth control method was approved by the FDA in 2002. The original manufacturer, Conceptus, was acquired by pharmaceutical giant Bayer in 2013. Bayer acknowledges certain side effects to the procedure, such as mild to moderate pain, cramping, vaginal bleeding following the Essure procedure, pelvic or back discomfort, nausea, vomiting or even fainting. These effects, according to Bayer, only last a few days after the procedure is done.
However, side effects reported by Essure users themselves have lasted far longer and been much more extreme. Some of the most severe side effects experienced by Essure users include the following:
- Severe abdominal pain
- Severe pelvic pain
- Perforated organs
- Life-threatening ectopic pregnancy
- Migration of the Essure device or its components
- Severe migraines
- Hysterectomy to remove the Essure device
Essure Birth Control Lawsuits
The FDA received thousands of complaints about Essure and ruled in September of 2015 that the packaging for Essure must include a “black box” warning that includes the known risks of the device and a Patient Decision Checklist to determine whether or not it is indeed the patient’s best option for pregnancy prevention. The FDA also recommended further research, including a follow up on the original clinical trial participants.
The FDA designated Essure as a Class III device, which means it was subjected to the most stringent testing prior to being approved. Because of this, Class III devices are shielded from product liability in most cases. A number of lawsuits have been filed to puncture that liability shield. In March of 2016, a Federal judge dismissed ten of the twelve claims out of a set of five such lawsuits, but allowed the remaining two claims to proceed—that Bayer used misleading advertising and failed to notify patients about the potential risks. The judge also merged the five cases into a single case. The case has not yet been resolved, but could potentially open Bayer to liability in further lawsuits.
File Your Claim Today
If you have had an Essure device implanted and suffered any of the above side effects, or if your Essure implants have broken, migrated to other parts of the body, perforated organs, lodged in the uterus or resulted in a hysterectomy, schedule a free case review with Pope McGlamry’s legal experts by contacting us or calling 877-285-7656.