Krystal Donahue’s Speech
Currently (September, 2015) there are over 7,000 Essure Adverse Events filed with the FDA.
A Study I co-authored was recently published by Pharmaceutical Medicine. It analyzed adverse event submissions from 1349 women received via the medwatcher app over a 7 month period.
One of the major findings was that 77.6% of these women reported Serious events, including hospitalization, disability, and permanent damage after implantation. Women whose only option for removal is a surgical procedure.
One patient reported 3 times before an investigation was completed. Once directly to Conceptus, once through the Medwatcher app updating to report surgeries and a diagnosis of cancer, and the third time, her doctor filed a report. The result of the 3rd complaint, was Bayer concluding that "since no product was returned...we were unable to perform an investigation."
As a voluntary reporter, I am not an extreme case. I did not get pregnant, develop life threatening complications, or get Cancer. My coils did not migrate or perforate. I did however endure physical pain and mental anguish for 2 years after being implanted with Essure.
My major complaints were abdominal pain, painful sex, extreme fatigue, joint pain, rashes, and abdominal swelling. I visited a doctor more than 20 times in the 2 years wearing essure. I had multiple blood tests, 4 ultrasounds, a ct scan, pelvic x-ray, a month of physical therapy, a cortisone injection, an exploratory laparoscopy where adhesions were found and cut, and lupron to rule out endometriosis. My primary care doctor finally told me that if I could not convince an OBGYN to remove them, he would refer me to a general surgeon.
I was finally able to find a doctor at a small practice who would discuss essure removal. After an internal exam where I convulsed off the table in pain, he agreed that they needed to come out right away. I had a hysterectomy on my 37th Birthday. I thank DrLacher, DrAdashack, and GBMC for freeing me from the pain essure caused.
I wish I could thank the FDA, ACOG, or Bayer for helping, but they are simply failing us... focused on profits.
Despite the thousands of women harmed and despite all the data presented today, Bayer and the FDA have Difficulty seeing the causal relationship between essure and our health due to limited data.
Adequate studies should be required before marketing a device that is meant to be worn for Life. This is totally unacceptable.
It is my opinion that Pre Market Approval should be revoked on this product due to continued patient harm from the procedure and wearing the device.