Family planning has become big business as more and more women and couples seek control over exactly when they choose to have children, in keeping with their life plan. Responsible adults want to ensure that they are well-prepared if and when they bring a child into the world, and drug companies are happy to accommodate with a slew of pharmaceuticals and medical devices designed to give women options for family planning.
Some women use pharmaceuticals like the birth control pill, while others seek more convenient long-term solutions or even methods of permanent contraception. The Essure System, a product introduced by Conceptus in 2002 (a company later purchased by Bayer), was designed as a permanent sterilization alternative to surgical procedures like laparoscopic surgery (a minimally-invasive procedure using tiny cameras), which was considered the standard of care to that point.
Unfortunately, a series of incomplete studies and omitted data led to reporting problems that allowed for this device to remain available on the U.S. market for nearly 16 years, despite a number of reported adverse effects that eventually led the product to be removed from the market. While Bayer claims the discontinuing of the product is due to declining sales, women negatively affected by the product have called it unsafe.
How did Essure make it to market? How has it adversely affected patients? What is the current state of affairs for this product and women affected by it?
Initial FDA Approval
The innovation of Essure was that it provided women with a convenient and non-invasive (i.e. non-surgical) method of permanent sterilization. The procedure, performed in a doctor’s office, involves no anesthesia, no cutting, and no visible scars. Instead, a soft, flexible coil device is inserted into fallopian tubes with the intention of causing fibrosis (thickening/scarring of surrounding tissue). Within about three months, the barrier formed by this procedure should stop sperm from reaching eggs, effectively preventing pregnancy.
The procedure became a popular alternative to laparoscopic surgery and hormonal birth control methods, with an estimated 750,00 plus women choosing Essure since it was approved by the FDA for sale in 2002. This Class III device was approved by the FDA under the Pre-Market Approval (PMA) process, which included two pre-market clinical trials, and as a condition of approval, the completion of two post-approval studies, including:
– A 5-year follow-up on participants from pre-market clinical trials
– Evaluation of the bilateral placement rate for newly trained physicians
What happened with these studies? The problems began with the pre-market clinical trials, which were nonrandomized, nonblinded studies featuring no comparator group. Further, the findings only included women involved in the study who successfully underwent the implantation procedure and then had 3-month follow-up results showing correct coil placement and tubal occlusion. The resulting conclusion by the FDA that the device would reliable for 97% of women was therefore flawed.
Not all results were included in the final findings and of those study participants who underwent the procedure, only 85% were followed-up with after one year to determine safety and effectiveness of the product, with only 25% included in a 2-year follow-up. The 5-year follow-up study, which included only 71% of women (and excluded women who did not have successful implantation, who became pregnant within 3 months of implantation, or who subsequently underwent hysterectomy), claimed a 100% success rate at preventing pregnancy.
The second required FDA study (evaluation of the bilateral placement rate for newly trained physicians) included 514 participants and was stopped early. Results indicate an 89% success rate for bilateral placement of devices, 38 device malfunctions, and 13 adverse events (perforation, pelvic pain, bleeding, and more). No follow-up was reported for this study. Still, the device was deemed safe.
New Model Approval
Under FDA guidelines, changes to devices that have undergone the PMA process require additional approval, which Essure sought in 2007 and received under the condition of a new post-marketing study. This supplemental study, which was supposed to include 800 participants, ultimately included only 578 patients that underwent the procedure. The trial was stopped early, no follow-up was conducted, and the study was never registered at ClinicalTrials.gov, despite requirement to do so by the 2007 FDA Amendments Act.
Updates to Labeling
Although the results of pre- and post-marketing trials for Essure are spotty, the FDA did elect to make adjustments to warning labels for the product several times, including the following:
– 2011 – warning for contraindication to nickel (i.e. nickel sensitivity) added
– 2012 – results of 5-year follow-up to Phase II and pivotal trials added, along with information related to pregnancies outside the clinical trials
– 2013 – warning for risks of chronic pain and device migration added
– 2016 – boxed warning label and Patient Decision Checklist added
– 2018 – restriction on sale and distribution of product to limited doctors and hospitals added
MAUDE Database Submissions and Lawsuits
The FDA provides a Manufacturer and User Facility Device Experience (MAUDE) database where consumers may report on their own experience with devices. As of June 2015, nearly 6,000 adverse-event reports had been made to MAUDE, relating to myriad safety concerns such as incomplete procedures, tubal perforations, pain and bleeding (in some cases leading to hysterectomies), unintended pregnancies, possible device-related deaths, and more.
The number of complaints rose to more than 16,000 by mid-2017, including over 9,000 cases of surgical removal of the device, frequently by hysterectomy. As of early July 2018, more than 16,000 lawsuits had been filed against Bayer alleging harm related to use of the Essure device. According to Bayer’s annual report for 2016, lawsuits related to Essure cost the company roughly $413 million that year alone.
Essure Removal from the U.S. Market
As of December 31, 2018, Bayer halted the sale and distribution of Essure in the U.S., although healthcare providers may still implant devices for up to a year following the purchase date of the device, in keeping with FDA regulations. Sale and distribution were also halted in Canada and many countries in Europe, Latin America, and Asia Pacific. According to the company, discontinuation is due to falling sales (which have dropped 70% in the U.S. since 2010), not safety issues. Many lawsuits against Bayer in relation to Essure are still pending.