GRAND RAPIDS, Mich.-- A major pharmaceutical company is pulling one of its birth control products off the market, citing low sales despite thousands of claims that it causes serious health complications.
Essure, made by Bayer Pharmaceuticals, was approved by the FDA in 2002. It consists of two metal coils that are implanted in a woman's Fallopian tubes to act as a barrier to keep sperm from reaching the egg to prevent pregnancy. It's marketed as a permanent, easy method of birth control.
"These coils are a polyester metal mix, and they look like a spring of a pen, and these springs actually go, are fed into the tubes, and, over a three-month period of time, the tubes scar around those springs," Dr. Pete Kaczkofsky tells FOX 17.
Kaczkofsky works for Metro Health in Wyoming, Mich., and says he's had a lot of patients with complications following Essure implants.
A Grand Rapids mother of two, Kristen Gorlewski, had complicated but successful pregnancies. When she was in her early 30s, she went to her doctor, looking for a permanent method of birth control. She says she followed her doctor's advice and got Essure.
When she went in for a follow-up appointment, she got horrifying news.
"Three months later I went in for the test; it's a dye test," Gorlewski tells FOX 17. "And they put the dye through, and during the test, there's this awkward silence of 'Hmm,' and she said, 'Wel,l it looks like one of the coils placed in your Fallopian tube, but I don't know where the other one is at.'"
Gorlewski says rather than suggesting a way to remedy the situation, her doctor suggested an 'exploratory surgery' to find the coil that had gone missing after implantation.
"She removed both of my Fallopian tubes, and I came out of surgery, and she said that the one coil she couldn't find was stuck in my uterus," Gorlewski says.
Gorlewski says her doctor told her that it wasn't possible to get that coil out of her uterus because it would cause too much bleeding, and that leaving it inside her wouldn't cause any harm. The doctor decided to only remove Gorlewski's Fallopian tubes.
Still, Gorlewski had her doubts.
"I went back in to see her, and I asked her, 'I think I need to have a hysterectomy done; I need to have this coil taken out,' and she refused," Gorlewski says.
Gorlewski says she battled with her doctor, who eventually agreed to waive her medical costs because of the complications. After seeing a new doctor, at only 32 years old, she got the life-changing surgery she needed.
"The first day of school for my kids, and I went in for surgery to have a hysterectomy done," Gorlewski says.
She would soon learn she was not alone. Thousands of women have reported complications from Essure.
"I've had issues, but mine are minor compared to what other women are going through because of it," Gorlewski says.
There have been claims of hair loss, extreme weight gain, loss of teeth and hair, fibromyalgia, and lupus. Some women have claimed that complications from Essure have caused their marriages to fail after being diagnosed with depression, to being told they were imagining the pain.
A common trait in women who claim to have complications from Essure is a nickel allergy. Nickel is the main metal used to make Essure.
Gorlewski says her doctor was fully aware of her nickel allergy before she gave her the Essure implants but didn't inform her that they were made of nickel.
Dr. Kaczkofsky told FOX 17 in June that his practice has decided not to use Essure until it is further reviewed by the FDA. This was before Bayer announced it will pull Essure from the market.
"I have had patients myself, either the Essure failed, one tube was scarred, the other tube wasn't," Kaczkofsky says. "I've had patients come back with symptoms of consistent bleeding. We've obtained ultra sounds; we've found Essure coils that were not in the correct places that they should be."
Bayer issued a statement to FOX 17 in June, reading in part,
"Over more than 15 years, Essure has been studied in more than 200,000 patients, both in pre- and post-approval studies, and this extensive body of scientific evidence establishes that Essure is comparable in safety and effectiveness to tubal ligation – an invasive surgical procedure that is the only other option for women who desire permanent birth control. The studies show that Essure has a strong track record of efficacy, preventing pregnancy in 99.3 percent of patients who chose to rely on Essure for birth control."
Gorlewski tells FOX 17 if she could go back in time and stop herself from using Essure, she would.
"I try not to place blame on myself, but if I would have informed myself better, I would have never had it done," Gorlewski says. "And I would shout from the rooftops to tell everybody not to have it done."
A site called ConsumerSafety.org provides information about recalls and product safety. The site has accumulated data into a timeline from when Essure was put on the market through spring of 2018. For information on lawsuits against Essure and its potential complications, click here.
On Friday, a documentary called The Bleeding Edge premiered on Netflix. The documentary focuses on the possible consequences of Essure. Bayer issued the following statement to FOX 17 regarding the documentary, reading in part,
“The Bleeding Edge presents an inaccurate and misleading picture of Essure, by cherry-picking information to fit a pre-determined conclusion, disregarding basic facts, and ignoring the full body of scientific evidence that supports FDA’s determination that Essure is safe and effective. In addition to lacking scientific basis, the film relies on many conflicted sources that are not disclosed, and does a disservice to women by potentially encouraging or frightening them into choosing risky surgery to remove Essure, which may not be necessary.”