FDA Panel Hears Complaints, Gives Recommendations About Essure

Troy Brown, RN

September 25, 2015

The US Food and Drug Administration (FDA) held a postmarket panel meeting yesterday to evaluate the benefits and risks of the Essure System (Bayer Healthcare) for female sterilization after receiving complaints from thousands of women about the device.

The Obstetrics and Gynecology Devices Panel of the FDA's Medical Devices Advisory Committee made a number of recommendations regarding patient selection, preimplantation medical counseling, product labeling, postimplantation testing and follow-up, and data collection. The panel did not vote on the recommendations, and the recommendations are not binding.

The Essure device is marketed as a nonsurgical alternative to tubal ligation that can be performed in a physician's office. It is a small flexible metal coil that is inserted into each fallopian tube through the cervix and uterus that causes inflammation that permanently occludes the fallopian tube by about 3 months after insertion.

The FDA approved Essure in November 2002 after its Obstetrics and Gynecology Devices Advisory Panel reviewed data from two clinical trials.

During the past 2 years, reports of adverse events have increased dramatically.

Reported adverse events include implant perforation and migration, chronic pain, allergic reactions, irregular bleeding, and unintended pregnancy. The panel also discussed issues related to device removal.

Investigational Device Exemption Studies Lacked Control Group

The meeting included discussion of three Investigational Device Exemption studies that were prospective, multicenter studies with several hundred subjects each, as well as a number of studies reported in peer-reviewed journals.

Two of the Investigational Device Exemption studies followed up patients for 5 years; the third study is still ongoing and has provided data out to 2 to 3 years. Those studies lack/lacked a control group, so interpretation of some outcomes of interest is limited. Data were not available for all study participants at the 5-year point for two of the studies.

"Although relatively low rates [of adverse events] were reported in many of these publications, significant limitations must be taken into account when reviewing the data, including a large amount of data being generated from retrospective studies (chart reviews, physician or patient surveys or telephone interviews, etc.), single-arm cohort studies, studies from single institutions, separate studies from the same institutions reporting on patient populations with significant overlap, studies with limited follow-up (e.g., 3 months), studies with notable loss to follow-up, and/or reviews using MDR data to estimate rates," the FDA explained in its report.

"I strongly urge the FDA to abide by its own statement, which it made in 1957, that the gold standard is the randomized clinical trial," nonvoting member Richard J. Chappell, PhD, from the University of Wisconsin–Madison, said.

The panel said additional data are needed, but conducting a randomized controlled trial at this point may not be practical or feasible. For this reason, the panel recommended creating a registry of patients who receive the Essure device that would allow tracking of adverse events.

Patient Selection, Counseling Vital

The panel recommended careful selection of patients, saying the device might not be appropriate for certain women, including those with hypersensitivity or allergy to nickel (Essure is part nickel), chronic pelvic pain, other autoimmune disorders, and prior uterine surgery.

Women who desire the device should be willing to be on reliable birth control for 3 months and return at that time for confirmation of placement and fallopian tube occlusion.

The panel stressed the importance of patient counseling regarding risks and potential adverse events. "Maybe some more bolder specific information needs to be given to patients...about autoimmune responses, what it is...a highlighted bulleted piece as opposed to a big long list with lots of information," nonvoting panel member Deborah L. Myers, MD, from the Women and Infants Hospital of Rhode Island, Providence, said.

More physician training is needed, particularly with respect to device removal, the panel noted. "We need to have some type of oversight afterwards, so that we can see whether or not...there are certain surgeons who are implanting who have higher-than-expected complication rates," temporary panel chair Cheryl B. Iglesia, MD, from MedStar Washington Hospital Center, Washington, DC, said.

Emotional Open Public Hearing

The meeting included a lengthy open public hearing at which 43 patients and other interested individuals spoke, many giving highly emotional testimony. Most asked the FDA to remove the device from the market, although several representatives from professional organizations and healthcare providers asked the FDA to continue to make it available to women.

"Today, Essure is the only permanent contraception that can be performed non-surgically, allowing women to avoid potential complications associated with surgery and general anesthesia, especially those with certain medical conditions," the American College of Obstetricians and Gynecologists, Physicians for Reproductive Health, and Planned Parenthood Federation of American said in a joint statement.

The three groups urged the FDA to "recognize that restricting women's access to certain methods of birth control will limit their choices and, in some cases, expose them to additional risk."

"Not a Pattern of Discordant Reporting"

In April 2015 the FDA opened an investigation into the device after allegations that Bayer falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about Essure's safety and efficacy, and used defective materials in manufacturing the device.

Two women at the open public hearing accused the company of falsifying medical records from clinical trials and showed what appeared to be examples. The FDA said it had examined records from 500 or 600 women and found six cases of possible medical record tampering. They were sporadic reports, and there was "not a pattern of discordant reporting," according to the FDA.

"We don't deny that adverse events occur, and we make every attempt to mitigate them as best as possible, and we sympathize with any patient who has experienced an adverse event. We look forward to working with the FDA on these recommendations that you have made," Edio Zampaglione, MD, vice-president, Women's Healthcare and Neurology, Bayer Healthcare, said.

The public docket will remain open until October 24, and the panel encouraged the public to post their comments to the public docket.

More information about Essure is available on the FDA's website.


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