Patients and doctors are clamoring to recall Essure, a nickel-based birth control device implanted into a woman’s fallopian tubes to make her permanently sterile. The FDA fast-tracked its review process, thanks to the device’s promise as a viable, safe alternative to surgical sterilization, and approved Essure in 2002.
It has taken years, but Essure is finally coming off the market, by the end of 2018. In July 2018, Essure’s manufacturer, Bayer, said it would stop selling Essurebecause of waning sales, although it stands behind the safety and efficacy of the product
Since 2002, roughly 17,000 adverse event reports worldwide have accumulated — 15,000 of which involved US patients. These reports have cited life-changing side effects, according to Bayer HealthCare’s director of global pharmacovigilance risk management, Andrea Machlitt, MD, who testifiedat a 2015 FDA advisory panel.
Women with Essure implants have claimed such side effects as severe abdominal pain, perforations of fallopian tubes, cysts, tumors, fatigue, loss of bowel control and auto-immune disease. Other complications, say doctors, include potential migration of the device and allergic reactions to nickel. Another grave concern is the difficulty removing the device once a problem is detected.
Was Anyone Tracking the Problems?
At the time it was approved, Essure was manufactured and marketed by Conceptus, which Bayer HealthCare Pharmaceuticals acquired in 2013. However, Bayer should have known about the problems because since its approval, the FDA has reviewed Essure’s safety issues, some resulting in labeling changes, notably:
- 2011:physician labeling updated to substitute a warning for a contraindication related to nickel. Current Essure labeling includes a nickel sensitivity warning.
- 2012:patient and physician labeling updated to include results of 5-year follow-up of subjects in Phase II and pivotal trials and information on pregnancies that have occurred in the commercial setting (i.e., outside of clinical trials).
- 2013:patient labeling updated to include risks of chronic pain and device migration.
- 2016: boxed warning and “patient decision checklist” mandated
- 2018: sales restricted to health care providers that provide information on risks and benefits of Essure
Who Reports Side Effects?
The FDA mandatesthat manufacturers, importers and device-user facilities (for example, hospitals and outpatient facilities) report device-related adverse events and product problems to the FDA within certain time limits. Device-user facilities which are not a physician’s office must report a suspected medical-device-related death to both the FDA and the manufacturer, but the rule does notstate that these facilities must report device malfunctions in which the malfunction would likely cause or contribute to death or serious injury if the malfunction were to recur, according to the FDA.
That said, these facilities can voluntarily inform the FDA of such product problems through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program, which is also available to patients who can also report problems directly to the FDA.
How Did Essure’s Side Effects Go Unnoticed?
Approximately 1 million Essure Systems have been distributed worldwide, according to the manufacturer(pdf), and the device has been implanted in more than 750,000 women since 2002.
So, why didn’t the problems with Essure get the FDA’s attention sooner? The FDA is finally facing the problems, especially as more women are suing Bayer. The first lawsuit was filed in May 2015, leading the way for others. But showing direct cause-and-effect relationship between side effects and the Essure device has raised questions.
‘I am here today, almost 13-plus years later, to say I was wrong,’ Gabriella Avina testified.
In fact, a petition has been submitted to the FDA by a Florida law firm, claiming that the small company that developed the device committed fraud by manipulating data in the clinical trials that led to FDA approval, according to a recent editorial in the New York Timeswhich called for suspension of Essure sales until better data is available.
The FDA also convened a public meeting of the Obstetrics and Gynecology Devices Panelin September 2015 to discuss scientific data regarding Essure’s safety and effectiveness. FDA officials invited feedback from patients, physicians and the public to to help address next steps.
What are the benefits of Essure?
Essure is meant to be a simpler, less invasive sterilization option than laparoscopic tubal ligation (getting your tubes tied), which is a surgical procedure performed in a hospital under general anesthesia. It doesn’t contain or release hormones; doesn’t require a skin incision or general anesthesia; and insertion is typically performed in a doctor’s office, often in just 10 minutes. Recovery is typically speedy; most women return to normal activity within 1 to 2 days.
What are the Risks?
More women are speaking out about Essure’s side effects thanks in part to a Facebook group called Essure Problems, started by an Essure patient. It has grown into a nonprofit, ASHES(Advocating Safety in Healthcare E-Sisters), which claims about 20,000 members, according to a report on Wired.com.
As a result, the FDA cites the following long-term risks:
- Unintended pregnancy, including ectopic pregnancy
- Pelvic pain
- Migration of Essure inserts through the fallopian tubes into the lower abdomen and pelvis
- Perforation of the uterus or fallopian tubes
- Rash and itching associated with possible nickel allergy
- Fetal complications including miscarriages in women who became pregnant following Essure placement
- Greater likelihood to have a pregnancy outside the uterus (ectopic pregnancy)
How Do Patients Feel?
The FDA heard all the above and more from patients and physicians who testified at the recent advisory committee meeting. Gabriella Avina took part in the original clinical trials and had worked for Conceptus, according to the New York Times, explaining the device to women when it first came on the market.
“I am here today, almost 13-plus years later, to say I was wrong” Avina testified. “Time has changed my thoughts, beliefs and, most importantly, my health. My health was in a tailspin, and I had failed to connect the dots,” she said. “The only foreign object in my body was the coil.”
Chandra Farmer, 33, said that after she had the device implanted several years ago, she had sudden bouts of muscle weakness so severe that she would collapse, leaving her helpless to care for her 3 children, 1 of whom was a toddler at the time. She could not stop falling asleep and had memory loss and hallucinations. She had a hysterectomy last year to get the device out of her body, and said she has not fallen down since.
Is the FDA Listening?
The agency claims it is. “The FDA takes reports of safety concerns seriously,” according to an FDA statementin September. “Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement, including complaints submitted to Bayer, device removal difficulties and other health effects.”
Even the physicians who implant the device aren’t sure if the side effects are actually caused by the device itself. “To be honest, we don’t know what we don’t know,” said Cheryl B. Iglesia, MD, of the MedStar Washington Hospital Center, who chaired the FDA’s Obstetrics and Gynecology Devices Panel.
At the end of the daylong testimony at the FDA panel, several experts seemed exasperated at the lack and inconsistency of adverse event records. As a result, they recommended gathering more safety data and establishing a patient registry to elicit more information about possible complications from the use of Essure, according to an FDA summary(pdf). There was discussion of the desire to ensure that patients have access to health care services related to all steps of the Essure system, including access to confirmation tests and to physicians trained in device removal.
The panel discussed the need for additional physician training on topics including device removal and the situations in which the placement procedure should be aborted and alternative options pursued. They expressed a general desire to see additional post-market data on the Essure system to better understand the adverse events that were discussed during the meeting, and they generally agreed that additional information regarding metal reactions/sensitivity is needed.
Committee members also considered patient populations for whom the benefit-risk profile of Essure is acceptable — or less so. It may be that hysteroscopic (using local anesthesia) sterilization is an important option for women who are not good candidates for laparoscopic or general surgery (e.g., obese patients, patients who cannot tolerate general anesthesia) and who are well informed of the potential risks of the device.
What Can A Patient Do Now?
Perhaps most surprising was the recognition by experts that regardless of data, a frank discussion between the patient and doctor about risks and benefits is crucial. “Be sure you have discussed in detail with a physician about the risk potential and alternatives before proceeding,” said Donna D. Baird, PhD, MPH, of the National Institutes of Health.
We have come a long way from the times in which patients, particularly women, didn’t routinely question doctors. Certainly that’s how I grew up — but I’ve had to learn to speak up. All patients need to be informed about risks and must be able to initiate a discussion with a doctor about treatment options. This important step of being informed about your treatment and medications could end up saving your life.