MINNEAPOLIS (KMSP) - A growing number of women are complaining about serious side effects from the permanent birth control Essure What's supposed to be a fairly simple procedure is turning into a medical nightmare for some.
With a blended family of seven, Elizabeth Fluegge and her husband decided to try a form of permanent birth control. Her doctor recommended the product that's been on the market since 2002.
You might have seen the commercials for Essure: "unlike getting your tubes tied, the Essure procedure is non-surgical and can be done right in your doctor's office."
A metal coil is inserted into each fallopian tube, tissue then grows around the coils to block conception. There's no surgery, but there are risks. According to the commercial, "common side effects include mild to moderate pain, cramping nausea, vomiting, fainting, vaginal bleeding."
Fluegge said ever since she underwent the procedure early last year, she's been miserable -- "I feel like everything's been stolen from me. I said the last ten months have been essentially hell."
It got so bad that in November, at the age of 36, she had a hysterectomy because it was her only option to remove the coils -- "I don't want any more women having to suffer the way I have," she said.
She's one of thousands of women in recent years who've complained to the FDA about problems related to Essure implants including perforations of the uterus, abnormal bleeding, and allergic reactions to the metal.
There are support groups on Facebook that call themselves "E-sisters," and four of them met with Fox 9.
"The fact is I was healthy and then I had them in and I was unhealthy," one said.
Each of them told the Fox 9 Investigators that they initially chose Essure because they liked the fact it didn't require a surgery. But when asked how many of the four women required surgery after getting the implant, all of them raised their hands.
A recent study of health records in New York State found women who got an Essure implant were ten times more likely to need a follow-up surgery compared to women who opted to have their tubes tied.
"One in fifty is likely to get surgery done again. But this time for the complications, likely to be complications related to the device," said Dr. Art Sedrakyan from Cornell University.
Researchers acknowledge there needs to be a better system of tracking problems that may be linked to Essure -- "At this point the recording of the complications is not complete," added Sedrakyan.
The maker of the birth control device, Bayer, said "a decade of real world experience supports the safety and efficacy of Essure."
But with so many complaints pouring in, the FDA said this is a high-priority issue. It's gathering input from medical experts and the public to see if anything needs to be done. And it promises an update by the end of February.