After the intense discussion and testimony, the FDA panel recommended that more data be collected regarding skin allergies and other symptoms, as well as demanding that doctors need to be trained more thoroughly on how to implant and remove the device, although stopping short of demanding that Bayer recall the product.
The groundswell of sentiment against Bayer’s controversial birth-control device Essure continued on Thursday, with medical experts adding to voices throughout social media condemning the product over health concerns. Beginning with celebrity activist Erin Brockovich’s call to action against the nickel-titanium, coil-like device, a tidal wave of opposition has formed due to chronic side-effects including over 20,000 members of the Facebook group “Essure Problems.” Over 17,000 adverse events have been attributed to the device worldwide out of about one million devices sold. 15,000 of those events have occurred in the U.S., where 60 percent of the devices are used. After receiving nearly 5,000 complaints from users who have experienced fatigue, heavy bleeding, as well as skin irritation assumed to be from allergies to nickel, the FDA convened the expert panel on Thursday to discuss the risks and side-effects, and whether Essure should remain on the market. In addition to the side-effects, another major concern is the lack of a standard procedure for removing the device, as the metal coils can become jagged, even leading to pierced fallopian tubes. Although Essure’s label warns of the risks of nickel allergy and the potential of puncturing the uterus upon removal, many objectors at the panel meeting believe that the warnings do not excuse the device’s serious hazards.
Despite the rampant concerns during the device’s history, especially in recent years, The Food and Drug Administration (FDA) granted “fast track” approval to Essure’s maker Conceptus in 2002, due to the fact that Essure was the first alternative to surgical sterilization, with a supposedly rapid recovery. Conceptus sold the rights to the device to Bayer in 2013 for $1.1 billion. In Thursday’s day-long session at the FDA headquarters in Silver Spring Maryland, 20 women told the panel of experts how the device’s debilitating symptoms negatively affected their lives. One witness was Elena Mendez, who told the panel, “Pain became my norm every day. This negatively impacted my marriage and I could not be the mother my children deserved.” One of the more alarming accounts was from Gabriella Avina, a former Bayer employee and a participant in an Essure clinical trial who has experienced deteriorating health, including celiac disease, a thyroid disorder, and myasthenia gravis, requiring hospitalization and chemotherapy. Avina told the panel, “My health was in a tailspin, and I had failed to connect the dots. The only foreign object in my body was the coil.” After the intense discussion and testimony, the FDA panel recommended that more data be collected regarding skin allergies and other symptoms, as well as demanding that doctors need to be trained more thoroughly on how to implant and remove the device, although stopping short of demanding that Bayer recall the product.
In addition to the testimonials calling for the removal of the product from the market, the panel’s experts grilled the FDA on its decision to approve Essure nearly as much as they did Bayer for selling it. At the drama’s peak, dermatologist Dr. Peter Schalock from Massachusetts General Hospital asked in a flabbergasted tone, “How can Bayer and the FDA have no knowledge of nickel allergies? Where did you test these people? How did you test these people? What did you test them with? Are we just making this up just for fun or is there data?” The president of the National Center for Health Research Diana Zuckerman even accused researchers of falsifying evidence during clinical research, an accusation which Bayer strongly denied. Dr. Dario Mirski, Bayer’s head of U.S. medical affairs at Bayer noted that Essure has been studied in over 10,000 women, saying in a statement, “There’s a need for safe and effective options for permanent birth control for women who have decided they’ve completed their families and that’s what Essure can provide for appropriate patients.” Dr. Mirski added, “Bayer stands by the positive benefit-risk profile of Essure, and we look forward to working closely with the FDA as it considers the Panel’s advice.” Although the FDA panel’s recommendations are not binding, the agency generally follows the advice of panel experts.
CTV News/Associated Press – Matthew Perrone
Fierce Medical Devices – Emily Wasserman
New York Times – Sabrina Tavernise