I-Team: Medical Procedure Causing Horrific Side Effects
BOSTON (CBS) - An easy method of family planning, with no big surgery or pills to remember, is becoming a concern for a growing number of women. They say Essure, tiny coils implanted in the fallopian tubes, are causing horrific side effects.
"Basically every single day it felt like my ovaries were getting stabbed," said Jessica LaVallie of Palmer.
Kendra Kilroy of Quincy said she had severe pains that were debilitating, and Marie Larsen of Holliston said she suffered with back pain, hip pain, and memory loss.
Melanie Goshgarian of Burlington now believes she suffers from an allergy to nickel as a result of Essure.
Kilroy described how her declining health impacted her quality of life. "I missed out on a lot with my kids. You know field trips. I remember my daughter crying. It was her birthday, and her very first field trip, and I couldn't go. I was just so sick."
After an Essure coil is inserted in the fallopian tube, tissue grows around the coil and seals it to prevent pregnancy.
The procedure results in permanent sterilization and is simple to do. It takes a matter of minutes and is performed in a doctor's office.
Stephanie Magno, now in her 40s, decided she was done having children after enduring two miscarriages. She said she had a bad reaction to Essure immediately. "I feel my fallopian tubes! I shouldn't feel them! Nobody feels them. I didn't feel them for 45 years before I had this procedure," said Magno.
Severe bloating left Jessica LaVallie of Palmer unrecognizable. 'I looked 9 months pregnant every day . . .it's not normal."
750,000 women have been implanted with Essure. The Bayer Company told the I-Team in a statement that "Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer reviewed publications."
Dr. Michelle Sia of the Boston Medical Center said side effects can vary, but that Essure is a viable alternative for women seeking permanent sterilization. She added it can be particularly beneficial for women with other medical issues or who may not tolerate some anesthetics.
Patients may "have some cramping or pain, but it is otherwise a well-tolerated procedure," explained Dr. Sia.
Medical explanations don't sit well with the five Massachusetts women who met with the I-Team. They feel let down by today's health care system. Melanie Goshgarian has suffered from numerous side effects. She said, "My primary care doctor kept checking me for everything, sending me everywhere and they would tell me there was nothing wrong with me and it just wore me down."
Kilroy said it was easy to question her own judgment, wondering if she had become a hypochondriac. "Am I crazy? Am I making this up?" Kilroy did an Internet search and came across an Essure support group on Facebook. "And it was like this light bulb went off, and I was like what? It was a revelation because I said, 'Finally somebody understands, finally somebody knows what I am going thru," Kilroy said thru tears.
The Facebook page brought together these five women, all from different parts of Massachusetts. It now has more than 3,000 members. The site is filled with horror stories from women all over the country. LaVallie hopes it provides a warning to all women. "Do your research, because honestly, I didn't."
Four of these five women have already had hysterectomies. The fifth is scheduled.
Marie Larsen believes that surgery, quite simply, gave her back her life, almost instantaneously. "I felt normal. I felt like myself. I didn't feel cranky anymore."
This isn't just a medical story. It is also a legal one. When the FDA approved Essure, it gave the device what is known a "pre-emption" status. This means women who feel they've suffered because of the coils can't sue the company that makes them.
There is a currently a push on social media to collect signatures and forward them to the FDA with the hope of getting them to review that policy.
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