The first lawsuits have been filed by women who accuse Bayer of failing to warn about complications of Essure, including debilitating chronic pain, uterine perforations, organ damage, and more.
Do I have an Essure Lawsuit? If you or a loved one was diagnosed with a complication of Essure birth control, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
What is Essure?
Essure is the first non-surgical alternative to tubal ligation (also known as having one’s “tubes tied”). It consists of two metal coils made of nickel-titanium and a polyester-like fiber called polyethylene terephthalate (PET).
How Does It Work?
The coils are placed into a woman’s fallopian tubes through the vagina. Once inserted, Essure triggers an inflammatory response that causes scar-tissue to form and block the fallopian tubes, preventing pregnancy.
FDA Receives Over 5,000 Essure Complication Reports
In September 2015, the FDA published a report (PDF) on Essure complications, warning that 5,093 adverse events had been filed on behalf of women who were injured.
Essure Complications “Literally Ruined My Life”
One victim talked to NPR and said:
“All of a sudden it hurt to have to move my body to get out of bed, to do anything. It feels like you’ve been hit by a truck every day of your life. For me, it’s been a nightmare. I mean, this device literally ruined my life.”
Essure Risks vs. Benefits
The FDA is currently investigating long-term risks of Essure. Lawmakers including Congresswoman Rosa DeLauro have asked the FDA to pull Essure off the market, warning that “Essure’s benefits do not outweigh its risks.”
Essure Complications
- Nickel allergy / hypersensitivity: At least 10% of women are allergic to nickel and develop rashes, itching, and inflammation. Essure is made of metal that includes a nickel-titanium alloy. The original label recommended a skin-test but Conceptus convinced the FDA to remove the warning in 2011.
- Migration of device outside of fallopian tubes: When Essure implanted too far, it can perforate the fallopian tubes and migrate into the abdomen. When Essure is not implanted far enough, it can migrate into the uterus and cause heavy bleeding and cramps.
- Chronic Pain: About 4.7% of women who get Essure report pelvic pain in the first year and 9% experienced back pain. The FDA warns that chronic pain can occur if Essure is positioned improperly, perforates organs, migrates, or causes an allergic reaction.
- Heavy Bleeding: Studies have found that 20-30% or more women experience heavy menstrual bleeding after getting Essure that is more frequent and prolonged.
- Fracturing of the device: Broken pieces of an Essure implant can cause perforations and they may need to be removed surgically.
- Perforation of fallopian tubes: This complication can occur during insertion or afterward, especially when Essure is not placed properly, and result in Essure migrating into the abdomen or pelvis.
- Organ damage: Essure implants that migrate into the abdomen can lacerate or puncture the bowel, bladder, uterus, or other organs. Surgery is necessary to remove Essure and repair the damage.
- Pregnancy: When Essure is implanted perfectly, it is over 99% effective at preventing pregnancy. However, with “real world” use, studies warn that up to 9.6% of women could become pregnant after getting Essure — nearly 4X the estimated risk for tubal ligation.
- Miscarriage: Pregnancies that occur when Essure is still implanted are “high-risk” because it can puncture the uterus or amniotic sac. The FDA has received reports of at least three late-term miscarriages.
- Ectopic pregnancy: Life-threatening pregnancy outside the uterus can burst the fallopian tubes and may require emergency surgery.
- Follow-Up Surgery: According to a recent study published in the British Medical Journal, 2.4% of women who get Essure need additional surgery — more than 10X the estimated risk for women who get a tubal ligation.
- Hysterectomy: Surgery to remove the uterus and reproductive organs is often the only cure when Essure causes severe complications. Unfortunately, a hysterectomy carries its own risks — including death.
- Death: The FDA has received reports of four women who died from complications linked to Essure, including uterine perforations, infections, and suicide. One woman died of a pulmonary embolism two weeks after getting a hysterectomy to remove Essure.
Do I have an Essure Lawsuit?
The Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Essure Lawsuit Evaluation: Again, if you or a loved one was diagnosed with a serious complication of Essure, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit, and our lawyers can help.
Attention Lawyers: Schmidt & Clark, LLP considers a referral from another lawyer to be one of the greatest compliments. Our law firm has built a reputation for success and accepts a number of case referrals on a regular basis. We do not publish prior verdicts or settlements on our website. If you would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please fill out the form below.