Susan Kelly, MedTech Dive, November 5, 2019
- FDA reminded healthcare providers of a year-end deadline to return Essure birth control devices that have not been implanted to manufacturer Bayer in an update published Monday on the agency’s postmarket review of the device. Bayer discontinued sales of the device on Dec. 31, 2018, following thousands of reports of complications with the permanent implant.
- The latest agency analysis of adverse event reports from 2002 through 2018 reveals 49 deaths linked to the device, though the FDA said it is difficult to discern whether the device caused the death. The most frequently reported patient problem was pain.
- FDA, which continues to evaluate long-term data on Essure, also said that 329 women had enrolled in the Essure arm of a five-year postmarket study as of Sept. 1, up from 307 enrolled as of April 1
FDA approved Essure for sale on Nov. 4, 2002. The agency’s most recent information shows that between November 2002 and December 2018, 32,773 medical device reports related to Essure were submitted to the Manufacturer and User Facility Device Experience (MAUDE) database. Among patient problems were 26,244 reports of pain, 13,114 reports of menstrual irregularities, 4,807 reports of hypersensitivity/rash, 3,410 reports of device migration, 1,533 reports of breakage/fragmentation, and 1,058 reports of implant failure or pregnancy. Most reports listed more than one issue.
The device consists of metal coils inserted into the fallopian tubes to block the passage of an egg. Scar tissue forms around the implant to prevent pregnancy.
In April 2018, FDA restricted the sale of Essure to healthcare providers who agreed to share a patient-doctor discussion checklist provided by Bayer with women who chose to get the device. Declining sales of Essure as the number of adverse events climbed prompted Bayer to announce in July 2018 that it would stop selling the product altogether, though the company continued to defend the safety of the device.
FDA required Bayer to conduct a postmarket study beginning in 2016, initially aiming to enroll 1,400 patients who received the Essure implant and another 1,400 women in a laparoscopic tubal ligation arm. But it later scaled back those targets because of the company’s market exit. In its latest update, FDA said a total of 1,002 patients were enrolled in the study as of Sept. 1, with 329 in the Essure arm and 673 in the tubal ligation group.
Diana Zuckerman, president of the National Center for Health Research, noted that the small sample size in the postmarket study, particularly the Essure arm, could limit its value.
“You are dealing with a smaller percentage than what they needed. It will depend on how well they analyze the data and how long they keep women in the study. That will tell us whether there is anything useful about the data,” she told MedTech Dive.
Zuckerman said the original clinical data supporting FDA’s approval of Essure was insufficient.
“The biggest lesson here is the importance of FDA requiring better research to begin with. If they had required a better study before putting this device on the market, they would have been able to make a better informed decision,” she said. “And women deserve that. To be able to make a decision based on solid information rather than advertising, and they did not have that.”
Metal-containing implants like Essure will be the subject of discussion for an FDA public meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee on Nov. 13-14.
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