Essure Lawsuits - Birth Control Device Litigation
FDA Announces Special Public Meeting To Discuss Essure
Essure is a permanent birth control method for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.
How does it work?
Unlike the traditional method of female sterilization, known as tubal ligation or "getting your tubes tied," implanting Essure doesn't require surgical incisions. Instead, a doctor can insert the implant through a woman's vagina, past her cervix and into the fallopian tubes. Over time, scar supposedly tissues builds up around the insert, forming a barrier that prevents sperm from reaching eggs in the fallopian tubes.
Because part of the device is made from a nickel-titanium alloy, patients with a nickel allergy may have an allergic reaction to the device, including rash, itching and hives, Bayer said.
Long-term risks to patients reported in clinical trials include:
- Unintended pregnancy
- Pelvic pain
- Perforation of the uterus or fallopian tubes
- Migration of Essure inserts through the fallopian tubes or uterus into the lower abdomen and pelvis
Other reactions following Essure placement not reported in clinical trials but included in medical device reports submitted to the FDA include:
- Allergy or hypersensitivity reactions
- Joint or muscle pain
- Muscle weakness
- Excessive fatigue
- Hair loss
- Weight changes
- Mood changes
- Persistent fever
The Essure Permanent Birth Control System is made up of two metal coils that doctors place inside the fallopian tubes. Bayer claims the device is nearly 100 percent effective at preventing pregnancy. But thousands of women are claiming the device injured them, and that it should be banned. Those same women are filing or have files lawsuits against the device’s maker.
The Moody Law Firm is investigating product liability claims for women implanted with this devise. If you or a loved one has been implanted with this devise or has experienced any of these events please contact us for a free case evaluation.