Essure birth control: Woman dies, doctor files FDA report about Essure coils
Sarah Buduson, newsnet5.com
4:58 PM, Nov 1, 2013
5:36 PM, Nov 1, 2013
Cleveland - 5 On Your Side Investigators have learned that an FDA report linking a woman's death to Essure was filed in September.
The Adverse Event Report says the woman died after being admitted to the hospital for abdominal pain. She had the permanent birth control device implanted this year, but it has not been determined what caused her death.
In the report, 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 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.
Bayer, the current manufacturer of Essure, provided NewsChannel5 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 FDA responded to our question about the report with this statement:
Adverse event and product problem reports do not necessarily indicate that a device is faulty or defective, or establish that a device caused the event. In order to comply with FDA regulations, device manufacturers must submit a report to the agency when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury, but submission of such a report isn't an admission that the product actually did cause or contribute to the event.