By Rebecca Bowers
EXECUTIVE SUMMARY
The Food and Drug Administration has issued new restrictions regarding the sale and distribution of the permanent contraceptive device, Essure.
- The regulatory agency said it was making the move after some women were not being informed adequately of the risks before having the device implanted, even after there were “significant efforts” to educate patients and clinicians about its risks.
- Some women who received the Essure device have experienced adverse events such as perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. Other women also have reported symptoms such as headache, fatigue, weight changes, hair loss, and mood changes, including depression.
The Food and Drug Administration (FDA) has issued new restrictions regarding the sale and distribution of the permanent contraceptive device, Essure.
The regulatory agency said it was making the move after some women were not being informed adequately of the risks before having the device implanted, even after there were “significant efforts” to educate patients and clinicians about its risks. (Contraceptive Technology Update reported on the FDA’s previous efforts; see the May 2016 article, “Food and Drug Administration takes steps to ensure safety of Essure,” at https://bit.ly/2rzaXgP.)
The agency says it is moving to enact restrictions after a review of new information on use of the device. The Essure System, approved for use in 2002, consists of an implantable insert and a delivery system to place the insert. In contrast to other procedures for permanent sterilization that require surgery, the Essure device involves using a hysteroscope to place inserts in each fallopian tube through the cervix. Once the device is in place, the fibers within the insert elicit a local reaction that causes fibrous tissue growth in and around the implant, thereby blocking the fallopian tubes. As part of the procedure, it is recommended that patients undergo a radiologic confirmation test using hysterosalpingography or ultrasound three months after placement of the insert to confirm correct placement and obstruction of the fallopian tubes.
Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine in Atlanta, points out that this confirmation test to demonstrate successful tubal occlusion does not always occur. He lists three reasons: Some physicians are convinced that their techniques are so good, they do not need confirmatory hysterosalpingography. Second, the cost of the confirmatory procedure leads some women and some clinicians to decide not to perform the confirmatory test. Third, while the initial procedure may have been paid for by one of several forms of insurance, the confirmatory test may not be covered, leaving women to decide not to have it done.
As a hysteroscopic sterilization procedure, Essure has some advantages compared to laparoscopic sterilization: it avoids abdominal entry, it can be implanted during an office procedure, and it may avoid the use of general anesthesia.
However, according to the FDA, some patients who have received Essure have experienced adverse events, such as perforation of the uterus and/or fallopian tubes, migration of the inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. Other women also have reported symptoms such as headache, fatigue, weight changes, hair loss, and mood changes, including depression. However, it is not known whether these symptoms are related to Essure, the agency states.
Essure originally was brought to market by Conceptus of Mountain View, CA, but the product was acquired by Bayer in June 2013. According to the FDA, in late 2013, the agency received a significant increase in reports of adverse events related to Essure, in particular from patients who had received the device. Essure is available in the United States, Canada, Australia, several European countries, some Latin and South American countries, and some Asia Pacific countries.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information,” said FDA Commissioner Scott Gottlieb, MD, in a press statement. “That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
What Steps Have Been Taken?
The company has made changes to the “Patient-Doctor Discussion Checklist,” which was added to the Essure label in November 2016. This checklist now includes the sub-title “Acceptance of Risk and Informed Decision Acknowledgement” to indicate the document’s importance. Clinicians must review the checklist with each prospective patient to ensure the patient understands the risks, benefits, and other information about Essure implantation. Clinicians will need to give each patient the opportunity to sign the acknowledgment, and the physician who is inserting the device must sign the checklist. Bayer, the device manufacturer, now is tasked with implementing the restrictions and ensuring that healthcare provider compliance falls in line with the restrictions.
In February 2016, the FDA ordered Bayer to conduct a new postmarket surveillance study of the device. The study, which is still ongoing, will provide information to help the agency understand the risks associated with Essure, including rates of complications such as unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the device, and compare them to those of laparoscopic tubal ligation. Although the agency says that Bayer’s post-market study has demonstrated adequate progress, including tripling the total number of enrolled patients during the past six months, it also plans to require the company to raise the number of study sites to account for declining sales volume.
Ensuring informed decision making is just one aspect of the FDA’s ongoing efforts to monitor use of the device, said Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.
“While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure,” said Cornelison in a prepared statement.
The Food and Drug Administration has issued new restrictions regarding the sale and distribution of the permanent contraceptive device, Essure.
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