Hundreds of women are using social media to voice their complaints about a permanent birth control device approved by the Food and Drug Administration 10 years ago.
Michelle Garcia of North Miami is one of them. She has a daughter and decided not to have more children.
“I wanted a method of permanent birth control, but I didn’t want to have anything done surgically,” said Garcia.
She chose Essure, which uses tiny coils to block fallopian tubes. The device is inserted through the cervix and uterus in a simple procedure.
Conceptus, the company that makes this device suggested we interview Kendall gynecologist Dr. Randy Karmin who has implanted hundreds. Karmin said she has never encountered a situation where somebody’s coils ended up in the abdomen.
Garcia has pictures and evidence to prove that part of one of her coils ended up in her abdomen.
“The main concern is the piece could move and perforate an organ in the abdomen,” said her surgeon Dr. Jacob Tangir.
Local
That wasn’t Garcia’s only concern.
“I was getting sharp stabbing pains in my pelvic area on both sides where the fallopian tube is,“ she said.
She added that her pain levels were 7, 8, or 9 on a scale of 1 to 10.
A year-and-a-half after she had Essure coils implanted in a doctor’s office to avoid surgery, she ended up having an operation at Memorial Hospital Miramar. Tangir removed the coils and both her tubes Oct. 4.
“Stabbing pain. I haven’t had one since they came out,” said Garcia.
Karmin says Essure is 99.8 percent effective at preventing pregnancy, has been implanted in hundreds of thousands of women and has a minimal complication rate.
“I haven’t had a single patient who requested to have the implants removed. There’s been overwhelming positive feedback,” said Karmin.
That is not the case on a Facebook group page for women with Essure problems . That page has more than 1,000 “likes.”
Recently Erin Brockovich launched a website about Essure, due to the number of complaints she has received from women around the country.
“She’s posting all of our stories out there because those who are speaking out are being very vocal because we’re all suffering the same ways,” said Garcia.
The FDA has received hundreds of adverse event reports related to Essure. Among the common complaints migrating coils, tubal perforations and pelvic pain.
Garcia and others would like to see the FDA investigate these reports and if necessary, pull the coils off the market.
Safety data from Conceptus shows 2.0 percent of patients in a study had perforations and 2.5 percent experienced severe pelvic or lower abdominal pain a year later.
“I’m sorry for the people that haven’t had a good experience, but the overwhelming evidence shows this is an excellent product and an excellent option for women,” said Karmin.
Conceptus said it cannot comment on individual cases but emailed NBC 6 a statement.
"Conceptus works in collaboration with physicians who are trained and certified to perform the Essure procedure, to provide patients with the necessary information to make an informed decision..."
Conceptus also stated all medical procedures do have risks and the most common side effects reported with Essure are mild discomfort or cramping.
