http://www.catholicnewsagency.com/images/size340/Coil_spring_Credit_Bryan_Birdwell_via_Flickr_CC_BY_NC_20CNA.jpgWashington D.C., Dec 31, 2015 / 05:35 pm (CNA).- Perforated organs, metal coils lodged in colons, fetal disfigurement due to nickel poisoning. Chronic pain, exhaustion, bouts of depression and suicidal thoughts.
It’s the stuff nightmares are made of. But these are real symptoms that are being blamed on a real medical device, one that is being protected by the FDA. The device, Essure, is a permanent type of birth control in the form of tiny metal coils inserted into women’s fallopian tubes.
But while it’s been on the market since 2002 and has been touted as safe and effective, thousands of people are starting to come forward and question the device, including doctors very familiar with it.
It started out as a standard procedure for Dr. Shawn Tassone, Ob/Gyn. He was inserting Essure coils into a patient. The 10 minute, in-office procedure was supposed to be quick, simple and painless, and it was one he had performed many times before.
“I remember…I put the Essure in, exactly like how you were supposed to, and then as I sat there the tube started to spasm, and it pulled the Essure in,” he told CNA. “It disappeared, it coiled right into the tube.”
Unsure of how to proceed, he looked at the product manufacturer’s representative, who was in the room with him. The representative told him to just put another coil in the same tube, but Dr. Tassone knew that was against the product’s instructions.
“I told (the representative) that, and he was like, ‘Nah, that’s not necessarily true’,” Dr. Tassone said. “And you’re just being told this stuff by these reps who are college graduates, and I’m sure their hearts are in the right place, but they also want you to do the procedure because they get reimbursed more.”
It was through personal experiences with patients, as well as hearing other women’s stories, that Dr. Tassone eventually stopped doing a procedure he’d once been so sure was safe and effective. He said that while he’s not a conspiracy theorist, he does believe there are a large number of women with severe complications from Essure that are not being acknowledged by the medical community at large.
A Facebook group 24,000 strong
A lot of these women can be found on the Facebook group, Essure Problems. Of the 24,000-plus members, the majority are women who share a strange kind of sisterly bond – almost all of them have had Essure, and almost all of them bitterly regret it.
When the Essure coils are implanted, they are supposed to stay in the fallopian tubes, where they create a chronic infection that will cause scar tissue to form around the coils, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.
Some possible side effects after the Essure insertion procedure are listed on the product’s website and include: “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body.”
Angela Desa-Lynch, an administrator for the Essure Problems group, said the women in the group have experienced these problems to the extreme.
“Whatever they’ve put on the label, multiply it by 200,” she said. “They say chronic pain, or they say mild cramping or abdomen pain, but they don’t tell you that it’s debilitating. They don’t tell you that it’s ‘I can’t get out of bed and take care of my kids’ kind of pain.”
When Desa-Lynch had her Essure coils in, she said she felt like she had the flu constantly. She was 28 years old, and her youngest son was just three months old.
“My little son…he had no idea the real parent I could be, because I was going through all these health problems,” she said. Desa-Lynch had to have a total hysterectomy to remove the coils, but she said the recovery process didn’t end with the removal.