BRONX, NEW YORK (PIX11) -- Lisa Saenz, 45, slid with great discomfort into a living room recliner, four days after she underwent a hysterectomy. The mother of three daughters didn’t have the operation to remove cancerous organs. Saenz said she couldn’t bear the pain any longer from a permanent, birth control device.
“He had to remove my uterus, cervix, fallopian tubes, and right ovary,” Saenz said of the surgeon who performed the operation. “There’s nine thousand-plus of us that are walking around with a lot of issues.”
Saenz is talking about the thousands of women who belong to a Facebook group complaining about side-effects from Essure, a form of non-surgical sterilization that was approved by the Food and Drug Administration in 2002.
About 750,000 women have had the procedure performed since then. It involves the insertion of metal coils into the fallopian tubes, which prevent eggs from meeting sperm and causing pregnancy.
Dolly Pena of Bay Ridge, Brooklyn had the Essure device implanted in May 2012. She was then a mother of four. Three months later, a follow-up showed that her tubes were “occluded”— closed.
Then, Pena got a huge surprise ten months after that, during a routine visit to her gynecologist.
“And he noticed I had a baby in my uterus,” Pena recalled to PIX 11. “He told me ‘You have a heartbeat and you’re five weeks pregnant,’ and I’m like ‘what?!’”
Pena’s fifth child, Valentina, was born five months ago. Pena is among the growing chorus of Essure recipients who want a safety review done on the product.
The Food and Drug Administration points out a five-year study was conducted by the developer of Essure, before the FDA approved the product in 2002.
It said no form of birth control is 100 percent effective and “the Essure procedure is 99.83 percent effective, when used according to the approved instructions for use.”
In Pena’s case, doctors later found the right Essure filament was not within her right Fallopian tube—enabling her to get pregnant.
Many of the women complaining about Essure—like Saenz—talk about chronic pain, depression, and weight gain.
Jennifer Reinl of Kings Park, Long Island said after she had the device implanted, she started having flu-like symptoms and a metal taste in her mouth.
She said then she had shooting pains in her legs, back and neck—and didn’t want to get out of bed. Reinl said she also gained 45 pounds.
“I didn’t want to go to family events,” Reinl—a mother of three—told PIX 11. “People were like, ‘what’s the matter with her?’—calling me bipolar.”
Reinl said she had vision problems and went for multiple colonoscopies, until she finally had a hysterectomy this past February—with the device removed.
“The pain in my back was gone,” Reinl told PIX 11. “The fog started lifting.”
Dr. Alan Adler—a gynecologist with Mount Sinai Medical Center—said to PIX11 “Any particular device, any particular procedure, always has risks versus benefits.”
The FDA said its own reviews showed no “causal connection between Essure and certain reported problems, such as extreme fatigue, depression and weight gain.”
But a group in Philadelphia has recently filed a lawsuit, claiming the makers of Essure hid negative information from the FDA, during early studies. Essure is now owned by Bayer Healthcare, which purchased the product from Conceptus, Inc.
The Facebook group has now gained a strong ally from environmental activist, Erin Brockovich, who is calling for a safety review of Essure.