Congresswoman Louise Slaughter, a democrat from New York, and Congressman Mike Fitzpatrick, a republican from Pennsylvania worked together to introduce a bill that would allow women harmed by the Essure device to sue maker Bayer. Essure is a permanent sterilization device that has caused harm to many women and has even been linked to deaths. Currently Bayer and Essure are protected from litigation, but if the bill passes, that could change.
Essure and Bayer
Essure was designed by Bayer to be an alternative to a tubal ligation for permanent birth control. It is inserted vaginally, and therefore requires no surgery, no stitches, and minimal recovery time. The device is made of two metal coils with fibers inside the coils. The coils hold the device in place in the fallopian tubes, while the fibers trigger the formation of scar tissue. Over the course of a few months, the scar tissue builds up to such an extent that it blocks the tubes and eggs cannot be released from the ovaries to the uterus.
Problems with Essure
Although Essure was supposed to be safer than a tubal ligation, this has not been the case for all women. Tubal ligation requires anesthesia and surgical incisions, which means there is a risk for complications like bleeding and infections. Essure does come with some potential side effects like bleeding, cramping, and nausea, for a day or two after the insertion, but many women have complained of much worse complications.
Some women have reported to the U.S. Food and Drug Administration (FDA) that they experienced severe abdominal and back pain and heavy bleeding. Some women have had their fallopian tubes perforated by the Essure device, and in extreme cases this has led to the device migrating out of the tubes and damaging other organs. Women have suffered permanent damage because of this.
Women with Essure implanted may still get pregnant, and if they do, the odds that it will be an ectopic pregnancy are high. This is a pregnancy in which the fertilized egg implants in the fallopian tubes. It is dangerous for both the mother and the child and most babies cannot be carried to term. Essure has even been linked to the deaths of a handful of women.
Protection under the Law for Bayer
Women who have been harmed by Essure, and advocates working on their behalf, have complained that they cannot sue Bayer over the damage the device has caused. Bayer is preempted from lawsuits regarding Essure because it is protected by the Medical Device Amendments Act. The FDA placed Essure in this protected category because it faced more rigorous scrutiny.
Ariel Grace’s Law
The bill that Slaughter and Fitzpatrick have brought to Congress includes Ariel Grace’s Law named for a stillborn child conceived while a woman had the Essure device implanted. This woman did not intend to get pregnant, but when the device failed her and she did, she was devastated to find that she could not bring the child to term alive.
The bill that the Congresswoman and Congressman hope to have passed by both the Senate and the House, would give victims of such medical devices a greater ability to take legal action against the manufacturer. Another law in the bill package would provide protections for physicians who bring faulty medical devices to the attention of the FDA and other agencies. This, it is hoped, would protect many more people like those harmed by Essure.
Women and their unborn children harmed by Essure trusted Bayer and the company let them down. A few women have died, hundreds of pregnancies ended in complications, and many more women suffered pain and organ damage because of Essure. Soon they may have the right to sue Bayer for justice and compensation.