Essure Procedure Side Effects Outlined in FDA Warning, Patient Checklist
Federal drug regulators are recommending even stronger warnings about the potential side effects of Essure procedures, which are designed to provide permanent sterilization for women, indicating that a boxed warning and patient decision checklist are necessary to make sure that women make an informed decision about the potential dangers linked to the device.
This week, the FDA released new labeling guidelines for Essure and all permanent hysteroscopically-placed tubal sterilization implants.
The guidance calls for manufacturers to add the strongest label warning possible, placing information about the risks of perforation of the uterus and fallopian tubes, pain and hypersensitivity reactions in a prominently placed black box.
A patient checklist about Essure procedure side effects will also be required, highlighting key risk information, and showing detailed probabilities for certain adverse events in different situations.
Essure is a medical device sold by Bayer Healthcare for permanent birth control, involving coils that are placed in the fallopian tubes, which cause scar tissue to form and prevent pregnancy.
While it has been marketed in recent years as a safe and hassle-free means of preventing pregnancy, thousands of women have reported severe and painful Essure procedure complications where the coils migrated, perforated the uterus, caused severe allergic reactions, infections, abdominal pain and other problems.
In September 2015, an FDA advisory committee met to review the safety of the Essure device. The new labeling guidelines came out of the findings of that meeting.
Recently, the FDA reported that it had received nearly 10,000 Essure adverse event reports between the date the device was first put on the market in November 2002, and the end of December 2015.
Of those, 6,989 involved pain or abdominal pain, 3,210 involved unusually heavy or other menstrual irregularities, 2,990 were reports of headaches, 2,159 reports of fatigue, 2088 reports of weight fluctuation, 2016 reports of patient-device incompatibility, such as nickel allergies, 854 reports of device migration, 490 reports that the Essure operated differently than expected, 429 reports that the Essure coils broke, 280 reports that it was difficult to remove, 199 reports of the Essure coils positioned incorrectly, and 187 reports that doctors had difficulty implanting it.
In many cases, reports included multiple complication complaints.
The FDA has also determined that there were four cases of adult deaths, 15 lost pregnancies reported, and two incidents where an infant died after live birth that involved Essure implants. There were also 631 reports of unwanted pregnancies. In 96 cases, those pregnancies were ectopic, which can be life-threatening.
The Essure labeling guidance gives an example of what the boxed warning should look like for it and similar birth control implants:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.
In addition to the new warning, the FDA says women should also be given a patient checklist related to the use of the device, and its safety and effectiveness. The FDA indicates women should be notified of the permanent and possibly irreversible nature of the implant, the fact that there are alternative contraceptives available, its effectiveness and the risk of unintended and ectopic pregnancies, common adverse events, long-term risks, and what signs and symptoms they should look out for that may indicate a problem.
Essure Procedure Lawsuits
The stronger warnings come as Bayer continues to face a growing number of Essure lawsuits filed in state and federal courts nationwide, each raising similar allegations that an unreasonably dangerous and defective device was sold to women nationwide, indicating that Bayer failed to adequately report problems with the device to the FDA, doctors or consumers.
As Essure injury lawyers continue to review cases, it is expected that the size of the litigation will continue to grow over the coming months and years.
The FDA warned that the new guidelines were coming back in February, when they announced that much stronger Essure warnings would be required to make sure doctors and women are informed of the potential risks. Bayer has also been ordered to conduct additional studies to better understand the safety of the implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.
An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.
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