Langton & Lott, PLLC
Essure Lawsuit

Essure is a birth control implant that was marketed as “non-surgical permanent birth control.”

Essure features two metal coils implanted into a woman’s fallopian tubes. This procedure could take place during a woman’s regular doctor’s visit. Once the coils expanded, they would cause scar tissue to form. This scar tissue would then block the fallopian tubes and prevent pregnancy.

According to the FDA, the following risks are associated with Essure:

Short-term risks to women with Essure as reported in clinical trials include:

• Mild to moderate pain during and immediately following the Essure placement procedure.
• Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.

Longer-term risks to women with Essure as reported in clinical trials include:

• Abdominal, pelvic, or back pain
• Tear or hole (perforation) of the uterus or fallopian tubes
• Unintended pregnancy
• Allergy or hypersensitivity reactions
• Essure inserts unexpectedly moved to the abdominal or pelvic cavity
• If a patient and health care provider decide to remove Essure, another surgery may be required.

Other reactions included in medical device reports submitted to the FDA include:

• Headache
• Feeling tired (fatigue)
• Weight changes
• Hair loss
• Mood changes, including depression

Also, it’s important for women considering Essure to know that based on clinical studies, approximately 8 percent of women who undergo attempts at Essure placement are not able to rely on the device (External Link Disclaimer) for birth control.

https://www.fda.gov/medical-devices/essure-permanent-birth-control/essure-benefits-and-risks

Essure, by the manufacturer’s design, creates scar tissue in the fallopian tube which it also grows into and becomes intertwined with. This makes it nearly impossible to remove an Essure implant on its own. The danger of an Essure implant breaking during the removal process makes the only way to guarantee the entire Essure length is removed to have a hysterectomy with bilateral salpingectomy. This is a removal of the uterus, cervix, and both fallopian tubes at once.

Yes, in fact after first being implanted with an Essure device, women are told they can not rely on the device for at least 3 months. According to the FDA, roughly 8% of women who were implanted with an Essure device are never able to rely on the device to prevent pregnancy. The FDA also says that Essure is a reliable form of birth control that meets the 99% effective rate used to market the product. However, this 99% effective rate only applies to Essure devices that have been “successfully” implanted for 5 years or more….

Yes, in fact, the FDA gave Essure pre-exemption status to shield it from liability. However, serious questions have been raised about the testing performed on Essure and the FDA approval process. You can view recordings of the serious concerns raised at the FDA approval hearing here: https://www.youtube.com/playlist?list=PLbHvTUbmc6zxo7-sjtk9DqxgrCESBYO2X

Doctors say that if you are not experiencing problems with your device that you should not have it removed due to the risk associated with removal. However, if you have an Essure device and are experiencing symptoms that could be related to Essure or begin to, you should contact your doctor immediately so you can find the best medical treatment for you.

Unfortunately, thousands of women are not able to afford the procedure to have Essure removed and continue to suffer as a result of this product. If you have suffered from any of the symptoms above and have an Essure device or had an Essure device removed, call us today so we can show that this sort of disregard for the safety of women will not be tolerated. Use any of the methods for contacting us available n this site and speak to an attorney about your claim now.