Essure Linked to High Rates of Miscarriage and Birth Defects
The US Food and Drug Administration (FDA) recently announced that it will require German drug maker Bayer AG to begin new safety studies on its permanent birth control device Essure.
The FDA also plans to require a “black box” label warning about the device’s potentially serious side effects, something the drug company has resisted in the past. In addition to the new boxed warning, the FDA will require a “Patient Decision Checklist” to help ensure women receive and understand information regarding the risks of this type of device.
Thousands of women have complained about suffering complications from the implant. As a result, women are beginning to speak out and file lawsuits.
Women claim the device has caused permanent injuries including autoimmune diseases, perforated organs and severe pelvic pain.
Among the thousands of reports the FDA had received about Essure, 631 women report becoming pregnant after receiving an Essure implant. Of those, 294 included pregnancy loss.
Recently, experts have questioned the FDA reporting process and have found that risks associated with Essure are significantly higher than reported.
Joe Lyon has represented hundreds of individuals harmed by pharmaceutical products nationwide. For questions related to the Essure lawsuit call for a no cost consultation (800) 513-2403.
Essure is a birth control system that over time creates a barrier in the Fallopian tubes that keeps sperm from reaching the eggs, thus preventing conception.
The U.S. FDA approved the Essure Permanent Birth Control System in 2002. Bayer AG, the current manufacturer, says about 1 million of the devices have been sold globally, the majority in the United States.
However, thousands of women are filing lawsuits, and making claims that Essure has caused significant damage to their bodies.
The FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. Bayer admits that women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than women who have not had the Essure placement procedure. This can be life-threatening.
The Essure system consists of two metal coils implanted in each Fallopian tube. The device itself is a small, flexible coil made from an alloy of nickel and titanium. A doctor inserts the coils in a procedure that typically takes less than 15 minutes.
Scar tissue is meant to develop in the tube to prevent fertilization. After about three months, tissue is supposed to form around the inserts, blocking the tubes and permanently preventing pregnancy.
While scar tissue forms, women are urged to use an alternative form of birth control.
While Bayer markets the Essure system as safe, effective, and “non-invasive,” a study published in the British Medical Journal reports that women who receive an Essure implant are 10 times more likely to need follow-up surgery, compared with women who get their tubes tied.
There are numerous other risks associated with Essure. Bayer acknowledges some risks to patients in its current warning packet, which were reported in clinical trials.
Short-term risks include:
New Warnings for Essure
Bayer is facing several lawsuits over Essure, yet it insists the device is effective when inserted properly.
The U.S. Food and Drug Administration announced actions to provide important information about the risks of using Essure.
Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, stated that “more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
This is not the first time Essure has been questioned by health officials. In the past, the FDA has required updates to the product’s labeling based on clinical trial information and patient reports about the device.
The FDA’s recent decision requires Bayer to conduct a new study designed to “provide important information about the risks of the device in a real-world environment.”
Now the company must follow patients who receive the device, and monitor problems.
This includes noting the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how much these complications affect a patient’s quality of life.
Public Outrage over Essure
Opponents of the device have waged a social media campaign to see that Essure is pulled from the market. There is a large Facebook group called Essure Problems, where thousands of female members share stories about health problems they have experienced after receiving the device.
The issue is so widespread in communities that congress has also questioned the device and Bayer’s intentions.
Rep. Mike Fitzpatrick, a congressman from Pennsylvania, has pushed the FDA to halt the device’s use. He has asked why the agency would allow Bayer to conduct their own safety studies, rather than have an independent party complete a report.
Even before the latest word from the FDA, Fitzpatrick publicly urged the agency in a letter to review an independent report that counted 303 fetal deaths.
Rep. Rosa DeLauro, from Connecticut added to the pressure by saying recently, “Essure should be off the market until the requested studies are completed.”
If you or a loved one suffered an injury due to Essure and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions