FDA panel will review safety of Essure permanent birth control device following patient deaths

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by Michael Heygood

Safety concerns about the Essure birth control device have prompted the Food and Drug Administration to schedule a public hearing to review scientific data and other information about the dangers of the product. The FDA has invited medical experts and women who have used Essure to offer their comments at a meeting of the agency’s Obstetrics and Gynecology Devices Panel scheduled for September 2015.

Essure was developed by a company called Conceptus Inc., which was later acquired by Bayer. Comprised of a soft, flexible metal spring made from an alloy of nickel and titanium, Essure is a permanent birth control product that was approved by the FDA in 2002 for women ages 21 through 45. Essure is designed to be inserted by an OBGYN into each of a woman’s fallopian tubes. The device causes scar tissue to grow around it, thereby blocking the fallopian tubes and preventing conception. Women who have had Essure inserted by a doctor must return three months later for an X-ray to confirm that their fallopian tubes are successfully blocked. After this point, the Essure is considered to be permanently effective.

In recent years, however, thousands of women have reported concerns about Essure to the FDA after they experienced serious and painful side effects from the device. According to FDA reports, the agency has received more than 5,000 reports of problems with Essure since the device was approved in the U.S. Some of the most serious side effects reported by Essure users have included abdominal pain, migration of the device, device breakage, and patient-device incompatibility (such as from a nickel allergy). Other symptoms, such as chronic fatigue, headache, menstrual irregularities, and other problems, have also been reported.

The FDA also warned that it had received reports of at least four women who died while using Essure. Although the agency cautioned that it was still too early to tell whether these deaths were caused by the birth control device, the reports may raise serious concerns about the safety of Essure for women who have already been implanted with the contraceptive.

However, these FDA reports of side effects from Essure may only scratch the surface of problems with the birth control device. A Facebook group for women who have experienced problems with Essure has gathered an alarming 18,000 members, many of whom report that they have experienced serious problems with Essure similar to those reported to the FDA.

In response to these reports, the FDA has updated its online warnings about the short-term and long-term risks of Essure. The updates warning states that women who use Essure may be at risk of short-term complications such as discomfort or vaginal bleeding, as well as long-term risks—including pelvic pain, ectopic pregnancy, migration of the device outside the fallopian tubes, and perforation of the uterus or fallopian tubes.

Experts are uncertain as to what regulatory or disciplinary actions the FDA panel will consider in light of these growing concerns about the safety of Essure. Possible actions may include stronger warning labels about the side effects of Essure, addition safety studies to assess the health risks associated with the device, or additional disciplinary options.

Heygood, Orr & Pearson and Dangerous Medical Devices

Essure birth control devices and other medical products are manufactured and sold with the intention of improving the health and quality of life for patients. But although the FDA and other agencies monitor the risks and effectiveness of these and other products, thousands of patients are seriously injured each year as a result of complications due to faulty design, improper manufacturing, or other problems with medical devices and other products.

Patients who have been injured by a birth control product or other medical device may be eligible to file a lawsuit against the manufacture for the injuries they have suffered. To successfully bring a claim involving a medical device or other defective product, patients need the assistance of a lawyer with the training and experience to handle their case, as well as the financial resources to pursue their claim in full and, if necessary, take their case to trial.

The lawyers at Heygood, Orr & Pearson have tried literally hundreds of cases to verdict and have settled hundreds more. Our attorneys have secured verdicts and settlements for our clients totaling more than $200 million, and have considerable experience with medical device and defective product litigation.

Above all, we firmly believe that when companies who manufacture medical devices fail to ensure that their products meet basic health and safety standards, they should be held accountable for the harm caused by their products in a court of law. Our firm is dedicated to the belief that all patients should have the right to experienced and qualified legal counsel to ensure that their interests are represented and that their rights are protected.

If you or a loved one has been injured by complications from a medical device, you may qualify to file a lawsuit and receive compensation for these injuries. For a free legal consultation and to find out whether you may qualify to file a lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few simple questions about your case to get started.