Essure is a small medical device marketed as a permanent birth control insert. It is designed for permanent implantation and sterilization. Essure consists of small metal coils which, when implanted into the fallopian tubes, cause scar tissue to grow, preventing impregnation.
After many women experienced medical issues and pain, complaints were levied against Essure's manufacturer Bayer HealthCare. This article is an overview of Essure legal issues, including:
- The risks and medical problems associated with Essure,
- The false marketing efforts and the Food and Drug Administration (FDA) approval concerns that contributed to the issue,
- The FDA's response, and
- Information on recent Essure lawsuits.
Essure Risks and Problems
The FDA gave Essure premarket approval in 2002. Premarket approval allowed Bayer to sell Essure on the medical market for clinical use following scientific and regulatory review by the FDA. As a result of this approval, Essure is protected from product liability lawsuits. The U.S. Supreme Court has held that certain medical devices are protected from state common law because the devices are federally regulated.
Despite the implantation of more than 750,000 Essure devices worldwide, the FDA has received more than 5,000 complaints against Bayer alleging side effects, such as:
- Device failure leading to pregnancies that ultimately failed due to fetal death
- Allergic or hypersensitive reactions to the metals used to create the device
- Device migration into the abdomen or pelvic area
- Perforation of the fallopian tubes and/or uterus
- Irregular or abnormal bleeding
- Severe and persistent pain
- Patient death
Approval and Marketing Concerns for Essure
Even though Essure's premarket approval protects it from product liability litigation, there have been challenges to both the validity of the FDA approval and how the product is marketed.
Concerns surrounding Bayer’s marketing of the device and FDA approval include:
- Doctors and patients were not clearly warned about several side effects and complications associated with Essure.
- Bayer allegedly withheld reports about device complications from the FDA to gain premarket approval.
- Bayer allegedly paid "kickbacks" in medical equipment to doctors to sell Essure devices.
In February 2016, the FDA required Bayer to conduct new device effectiveness and safety studies to keep Essure's premarket approval. The FDA also now requires Bayer to sell Essure with a "black box" warning on its packaging. The black box warning provides information to medical practitioners and patients about severe or fatal side effects.
Additionally, Congressman Michael Fitzpatrick (R-PA) has spearheaded an effort to pass the E-Free Act (along with Essure's critics and legislative sponsors). If approved, the E-Free Act (H.R. 3920) could force the FDA to withdraw Essure's premarket approval.
Current Essure Lawsuits in U.S.
While relatively few lawsuits have been brought against Essure in the U.S., courts have allowed a few cases to proceed past summary judgment to trial.
Heather Walsh from Florida was the first woman in the U.S. to file a lawsuit against Bayer in 2013. A Bayer representative was meant to supervise her Essure implantation in 2008 but failed to attend the initial procedure.
Walsh ended up with three Essure devices implanted instead of the standard two after several more unsupervised attempts by her doctor. One of the coils embedded itself behind her colon, requiring a hysterectomy and additional surgery for removal. She suffered two years of severe pain and four hospitalizations.
Meanwhile, in a separate Essure lawsuit filed in March 2016, a federal judge allowed two causes of action to go to trial in Pennsylvania. U.S. District Judge John Padova ruled that these two causes of action could proceed: 1) failure to warn patients and medical practitioners of Essure's risks, and 2) negligent misrepresentation. This may prove to be an important legal ruling for future Essure lawsuits.
Get Legal Help
If you or someone you know have suffered injuries and financial or emotional stress from Essure complications, contact an attorney. An experienced personal injury attorney can help educate you about your legal rights and protect them in court.
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