Bayer posts final analysis of Essure adverse events to FDA

Dive Brief:

Bayer has posted its final analysis of adverse events reported for its permanent birth control implant Essure taken from social media and met the requirements of the variance from standard reporting requirements granted by FDA.
The final report includes one month of additional data. In that one month, March 2021, the number of adverse event reports submitted to FDA normalized after the surge at the start of the year.
Only one of the new reports derived from a social media post made since 2019. As it has done previously, FDA cautioned that "reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts."

Dive Insight:

Bayer stopped selling Essure in the U.S. in late 2018, following tens of thousands of reports of complications in patients that ranged from pain to device migration and breakage and facing a mountain of litigation. At the time, 49 deaths had been linked to the implant.

Bayer has stood by the safety of the product and called its move a business decision.

Approved by FDA in 2002, 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.

Bayer asked FDA for a variance from medical device reporting (MDR) requirements after it received adverse event information as part of litigation. FDA granted the request and gave Bayer one year to process all reportable adverse events contained in the information it received.

With the publication of the fourth and final analysis report, Bayer has met the FDA request ahead of schedule. The previous reports each covered a three-month period. Bayer had another three months to complete its analysis but the final report only adds one month to the dataset.

In that month, Bayer submitted 5,312 variance MDRs to FDA, well down on the more than 10,000 it filed in both January and February. The number of serious injury and malfunction variance MDRs also fell from the start of the year to a level in line with that seen in 2020.

The only figure that ticked up was deaths. Bayer dealt with most of the death variance MDRs at the start of the process, submitting 53 reports to FDA in the first month. Across the second and third reports, Bayer never submitted more than seven death variance MDRs in a month. In the last month, Bayer filed 14 death variance MDRs.

Again, the reports cover historical social media posts and do not necessarily represent unique cases. Most of the variance MDRs relate to social media posts made between 2014 and 2016. Only 476 of all 33,492 variance MDRs with posting dates submitted by Bayer, and just one of the latest batch of reports, related to posts made since 2019.

The submission of the final report completes the reporting of the litigation information. It is unclear whether the process has generated any knowledge, with FDA noting that "the nature of the information limits the ability to draw conclusions as to whether the device, or its removal, caused or contributed to any of the reported deaths or other events in the reports."