We recently shared the results of our months-long investigation into the Hidden Harms of various drugs and medical devices. In doing so, we hoped to shed light on the many ways in which patients can be misled by confusing or incomplete drug and medical device labels. Today, we continue those efforts by kicking off our Hidden Harms blog series. Each post in the series will focus on one drug or device from our investigation, exposing the contrast between marketing messages and reality--as experienced by actual patients.
We begin our series with Essure, the non-surgical implant once touted as an ideal alternative to tubal ligation. The silicone and metal Essure inserts were supposed to provide a convenient, safe form of permanent sterilization, but many implant recipients experienced life-altering side effects. More than 30,000 of the women harmed by Essure have filed lawsuits claiming Bayer and Conceptus--the original manufacturer--failed to warn them of risks associated with the device.
Keep reading to understand how Essure marketing and labeling materials failed to communicate possible risks, leading many women to unexpected and serious consequences.
The Human Face of Essure's Hidden Harms
Keisha Carney and her husband had eight children between them. "God has blessed us abundantly," she told the Washington Post, "We knew we were done." After speaking with her OB-GYN, Keisha underwent permanent sterilization through Essure implantation.
At first blush, the procedure seemed to be a success. But then strange symptoms appeared. Keisha suddenly developed recurrent, serious tooth infections, eventually losing five teeth. Her hair started falling out. She lived with constant brain fog and fatigue, whether she slept or not, and she gained weight.
Then she missed a period. She wanted to believe she couldn't be pregnant, because her doctor had assured her that Essure was "the most effective method of permanent birth control available." But Keisha wanted reassurance, so she bought a drugstore pregnancy test.
She was pregnant.
Keisha went online where she learned that other Essure recipients were experiencing symptoms similar to her own, including unplanned pregnancy. She wanted the implants out but couldn't do anything about it until she delivered the child she was carrying.
Keisha's pregnancy was plagued with problems: widespread pain, lower back pain that sometimes paralyzed her, and depression. Doctors attempted to remove her Essure devices during Cesarean section delivery, but they couldn't retrieve a fragment that had migrated near her colon.
A hysterectomy finally removed the last known Essure fragment from Keisha's abdomen, a hysterectomy she never intended to have. She says her symptoms changed immediately. The stabbing pains in her back stopped, her hair started to grow back, and the recurrent tooth infections disappeared. Keisha says she still struggles with brain fog and a few aches and pains, but overall, things have improved since ridding her body of the Essure devices.
Nothing about Keisha Carney's Essure experience conformed to the information she received from her doctor. Similarly, Keisha's Essure saga contrasts sharply with expectations set by the patient brochure and label information.
Essure Patient Brochure and Label Messaging
Though patients should have access to the official device label and instructions for use, many only ever examine the patient information booklets for implants. In the case of Essure, patients were given a 19-page document replete with smiling, middle-aged women extolling the virtues of the Essure implants.
The first page of the 2007 brochure proclaimed Essure a "Simple Option for Permanent Birth Control" in large, bold, blue lettering. Turning the page, potential users learned the benefits of Essure:
- Covered by Most Insurance Plans
- No Cutting Into the Body
- Rapid Recovery
- Can Be Done in An Office Setting
- Confirmation of Placement
- High Patient Satisfaction
- No General Anesthesia Required
Readers learned of Essure's 99.8% success rate in preventing pregnancy in addition to the user comfort ratings ranging from good to excellent within 1 week of implantation.
The brochure informed women that a simple test could confirm proper placement of the inserts and give them peace of mind about their sterilization status. Buried deep in the later portions of the brochure, women who continued reading learned that they would have to use alternative birth control for 3 months prior to confirming placement and function of the inserts.
The brochure did not inform women that they absolutely could not rely on the Essure inserts until and unless they underwent the confirmation test with positive results. Keisha Carney never had the test done, because her insurance would not cover it.
The original patient brochure instructed women with confirmed nickel allergies not to go forward with Essure, but the FDA later approved a label change downgrading this contraindication to a warning. "The data did not meet the threshold of a known hazard," according to an FDA spokesperson. Some women asked their doctors about potential nickel allergies only to have their concerns dismissed, possibly as a result of this labeling change.
Essure's Hidden Harms
During our Hidden Harms investigation, we analyzed over 40,000 Essure adverse event reports hoping to distill the true incidence of adverse events mentioned and unmentioned in the Essure patient and physician materials. Ultimately, such reports could not provide reliable estimates of side effect incidence, but scientific studies could.
Chronic Pelvic Pain
A clinical study in Canada found that 4.2% of Essure users developed chronic pelvic pain after device implantation. Neither the term "chronic pelvic pain" nor any of its derivatives appear anywhere in the Essure Instructions for Use or the Patient Information Brochure.
Many studies have attempted to estimate the rate of unintended pregnancy after Essure sterilization, but few have succeeded. A 2014 study used a mathematical model combined with published Essure placement success rates and short-term unintended pregnancy rates to predict the expected long-term unintended pregnancy rate. The model indicated that 1 in 10 Essure recipients would have an unintended pregnancy over a ten year period.
According to Essure materials, almost every other form of birth control has a lower failure rate than the one found for Essure. Keisha Carney said she felt betrayed by the contrast between the rosy message presented in Essure materials and the stark reality of the device's relatively frequent failure to prevent pregnancy.
Informed Women Stopped Choosing Essure
After years of public outcry from Essure users, the FDA finally took additional steps to ensure transparent risk communication with potential patients. Once the FDA began requiring physicians to complete a mandatory communication checklist prior to Essure implantation, sales plummeted. Bayer announced Essure's removal from the market just months later.
The original Essure marketing materials did not communicate risks transparently. Some were buried in text-heavy pages, and others were entirely absent. Women did not fully understand the implications of Essure implantation, and many were then surprised by the health consequences of the device.
When patients truly understood the risks, they did not choose Essure. Based upon the success of the Essure patient communication checklist, we hope to see similar communication requirements for drugs and medical devices of the future. You can find additional examples of transparent risk communication in our Hidden Harms Risk Explorer.
*For the purposes of this post, we examined the 2007 version of the Essure Patient Information Brochure.