SILVER SPRING, Md. -- An FDA advisory committee will meet Thursday to explore the safety and efficacy of a female sterilization device that has had numerous adverse events associated with it.
The Essure System is a form of permanent birth control that is implanted without surgery. Conceptus, a subsidiary of Bayer Health in Mountainview, Calif., received FDA approval for the device in 2002.
According to , more than 750,000 Essure procedures occurred worldwide from November 2002 through early 2013. At the time the premarket approval application (PMA) was submitted to the agency, the device was already available in Australia, Indonesia, and Canada, as well as more than a dozen European countries.
Now, the of the Medical Devices Advisory Committee has been summoned in response to adverse events reported with the device over the last 2 years.
For instance, Tish Scott, 34, of Drakesville, Ohio, had the Essure device implanted after having three children. Tish told she has been in "constant pain" ever since the device was implanted.
"It feels like you've been hit by a truck every day of your life... this device literally ruined my life," she said.
According to agency briefing documents, events reported in association with the Essure device include:
- Procedural pain that is persistent, or new pain that arises at a later point
- Perforation of the uterus and/or fallopian tubes by the Essure insert
- Intra-abdominal or pelvic device migration
- Post-implantation bleeding irregularities
- Metal (nickel, nitinol) allergy or hypersensitivity reaction
- Pregnancy (e.g., ectopic pregnancy)
The device is indicated only for women seeking permanent birth control or sterilization. The device is contraindicated for women who are unsure of whether they intend to become pregnant in the future, are currently taking corticosteroids, who have already received a tubal ligation, or who may be pregnant. The device is currently the only hysteroscopic sterilization procedure available. The Adiana System, available from 2009 to 2012, was withdrawn "for reasons unrelated to safety and effectiveness."
The Essure system consists of an implantable, expandable nickel-titanium coil with a stainless steel coil inside it. After insertion, the device "conforms" to the fallopian tube. The implanted coil triggers tissue growth that ultimately blocks the fallopian tubes, preventing sperm from entering the duct and fertilizing oocytes. The product includes a "delivery catheter" and a handle used to release the insert.
Women are instructed to continue using traditional contraception until their physician can confirm total occlusion of their fallopian tubes, usually at 3 months.
In July 2002, the ob-gyn panel voted to recommend "approval with conditions" for the device with eight members recommending approval and one abstaining. The committee recommended that:
- A confirmatory hysterosalpingogram be done after placement
- Any physician performing the procedure be required to attend a training program
- The label include warnings related to metal allergy, electrocautery, and potential pregnancy occurring after implantation
In November 2002, the FDA granted approval of Essure based on the committee's recommendations and a PMA that included clinical results of a two trials with at least 1 year of follow-up. The agency required that data collection from both studies extend to 5 years following discontinuation of alternative contraception, according to briefing documents. It also mandated a study to explore "placement rates of newly-trained physicians."
Five-year results from the required post-approval studies were completed in 2008 as part of the Investigational Device Exemption (IDE) program. These prospective multi-center studies included hundreds of participants and were conducted with guidance from the agency.
After 5 years, the first two studies found that none of the women reliant on Essure became pregnant. However, there were four luteal phase pregnancies in the pivotal trial (pregnancies that began prior to the procedure but were not detected). No deaths were reported in the phase II trial. One woman with leukemia died in the post-market follow-up of the pivotal trial. Thirty-two women reportedly had the Essure device removed.
Over the course of eight follow-up points during the 5-year reporting period for the two trials, 99% of women were said to have rated the comfort of the device as "good" or "excellent." However, some participants in the initial clinical trials alleged that their responses regarding the device comfort were "not recorded accurately by clinical staff," the agency noted in its briefing document. Agency inspections at Conceptus and one clinical site, however supported the PMA. A third IDE study is still ongoing.
The FDA committee will also examine the recent peer-reviewed literature related to the device, which according to FDA briefing documents found "relatively low rates" of adverse outcomes. However, it noted a host of limitations, such as studies dependent on retrospective data, studies focused on a single facility, studies with "significant overlap" among patients, and studies that demonstrated "notable loss to follow-up."
The committee will also review medical device reports (MDRs) received by the FDA's Manufacturer and User Facility Device Experience (MAUDE) database and information gleaned from "social media listening tools." The limitations of MDRs include "under-reporting and biased or incomplete/unverified reporting," according to the agency.
The device maker and patients will have input during the meeting. Issues that the FDA committee will consider include possible risk mitigation strategies, revised physician training approaches, changes to patient selection, suggestions for post-operative monitoring, and changes to labeling. The committee also may weigh in on whether to continue post-marketing safety or clinical data collection, and the device's overall risk-benefit profile.