Now, the ABC15 Investigators found a new Adverse Event Report filed with the FDA just weeks ago regarding Essure. It details a woman’s death after she was admitted to the hospital for abdominal pain. She had the Essure coils implanted this year, but it has not been determined what caused her death.
‘THE LATEST AND GREATEST’
Amanda Holt saw a lot of positives when she decided to get Essure as a permanent form of birth control.
“I have three children. I work at lightning speed. And when someone told me that I can go in and get this procedure done and then go back to work that afternoon or the next morning, I’m like, ‘Absolutely! Sign me up!’” she said.
For Katie Reader, Essure sounded like a great idea. “I wanted the latest and greatest,” she said.
They say they were told that Essure would be cheaper, faster and less invasive than getting their tubes tied.
During the Essure procedure, small metal coils are implanted inside the fallopian tubes to block conception.
But now, after years of painful side-effects, many women like Holt and Reader say Essure has turned into a nightmare.
Thousands of women like them have taken to social media. There are private and public Facebook groups dedicated to issues with Essure where thousands of women are sharing their experiences. The posts show woman after woman, many with the exact same symptoms, telling nightmare scenarios after getting the Essure coils implanted.
Most of the comments and photos detail side effects from an allergy to nickel, which is a component of the coils. Originally, women were advised to test for that allergy before getting Essure, but the manufacturer asked the FDA to remove that requirement a few years ago.
Women in the Facebook group describe extreme bloating, skin rashes and headaches. X-rays show the coils perforated the fallopian tubes of some women. And there are photos of broken coils after they were removed.
When the FDA approved Essure in 2002, it gave the device preemption status. That means a women who is injured by it can't sue the manufacturer.
A DEATH REPORTED
In an Adverse Event Report filed with the FDA on September 19, 2013, a physician describes a patient who had the Essure coils implanted this year going to the “emergency room with abdominal pain.” There, a different doctor “performed a pelvic exam [and] found the patient’s cervix, fallopian tubes and uterus were necrotic.”
The report goes on to describe the patient as testing positive for a type of strep infection. Then, the “patient went into renal failure and dic, and patient passed away,” the report said.
The doctor “believes the cause of death was related to necrotizing group a streptococcus infection (streptococcal toxic shock syndrome),” the report said.
The ABC15 Investigators contacted the FDA for a comment on this story, but they did not provide a response.
Bayer, the current manufacturer of Essure, provided ABC15 with this statement:
Although we do not comment on individual adverse events, we do take all adverse events seriously, and they are reported to the US FDA as required.
This is also a Manufacturer Narrative on the Adverse Event Report. It states, “The medical opinion of the attending physician was that the cause of death was not directly related to the essure inserts or procedure.”
Bayer would not elaborate on this explanation or confirm that they provided it to the FDA.
The company that developed Essure, Conceptus, conducted the clinical trials and asked the FDA to remove the nickel allergy testing advisory.
Bayer Healthcare bought Conceptus last June.
Bayer provided the following statement in response to our original investigation:
At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness.
Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control. A recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements.
All Essure studies that are either planned or active are listed on ClinicalTrials.gov. Bayer is developing the next generation Essure and is in the process of planning the clinical trial program.
Per your question regarding the nickel warning, I want to note that the use of a nickel titanium alloy in Essure remains as a warning in the product label. It can be found on page 1 of the Essure Information For Use insert in the Warnings section. The language is pasted below:
From Warnings Section:
The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.
In regards to the classification of Essure, the US Food and Drug Administration, not the manufacturer, classifies medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Devices are classified into one of three categories—
Class I, Class II, and Class III.
Class III devices are subject to the highest level of regulatory control. For Class III devices, such as Essure, a premarket approval (PMA) application is required by the FDA before they are marketed. Through the scientific and regulatory review of the PMA application, the safety and effectiveness of Class III medical devices is evaluated by the FDA.
No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.