In 2009, Angie Firmalino had two tiny nickel coils placed in her fallopian tubes — the inserts of the permanent birth control device Essure, billed as revolutionary for being implanted nonsurgically and with relative ease at a doctor's office. Ideally, tissue builds around the coils, scarring them into place and blocking the fertilization of eggs.
But Firmalino immediately began experiencing problems, including heavy bleeding and back pain. Two years later, she discovered that one of the coils had dropped into her uterus and the other had rolled into a little ball, partially expelled from a Fallopian tube. Firmalino found a doctor to perform surgery to remove them, but after the operation, health problems gradually returned. Eventually, her primary care doctor ordered a pelvic X-ray, which revealed foreign bodies scattered throughout her abdomen.
“There was no information about removal out there,” Firmalino, who went on to found the Facebook advocacy group Essure Problems, said, referring to the time before her first surgery. In 2014, she had a hysterectomy and two more surgeries that took her a year to recover from. She still suffers from chronic pain and severe headaches.
Although the literature on Essure removal is growing, guidance for physicians on how best to remove the device is scant. As is the number of physicians — about 30 — who have experience performing the tricky procedure rife with potential complications. This dearth of information and skill poses risks, in addition to the damage they say the device has already caused, to women who want — or need — Essure out of their bodies.
Patients who want the device removed are left “hoping and praying that your physician does it right,” said Firmalino.
Between Nov. 4, 2002, when it approved Essure, and the end of 2015, the Food and Drug Administration received nearly 10,000 Essure-related reports including pain, device migration or breakage, and allergic reactions to nickel, with 280 reports noting the device as difficult to remove.
“You have a lot of doctors making mistakes removing them,” said Dr. Julio Novoa, an OB-GYN based in El Paso, Texas, who consults for Essure Problems and said he has reviewed 400 to 500 cases of complications related to Essure removal.
No matter what procedure they follow, doctors can unwittingly break the coil as they try to remove it, leaving behind pieces that can migrate to other parts of the body or perforate organs, according to Novoa. “It's really bad, even when there's a tiny fragment left behind,” he said.
Most attention to Essure, however, is not directed toward complications of device removal.
Thousands of women who say Essure injured them have filed lawsuits against Bayer, while the FDA has been focused on patient and physician awareness and education by updating its labeling guidance. Bayer, Essure's manufacturer, maintains that the device is appropriate for most women who want permanent birth control. Few besides some highly vocal patients and doctors seem to be drawing attention to the problems that appear if the device is not extracted in full.
It's not clear how many doctors have even heard of Essure, much less know how to remove it safely, said J. R. Garcia, who spoke on the condition that her full name not be used because of pending litigation. An administrator of Essure Problems, she based her observations on conversations she's seen on the Facebook page, which has nearly 13,000 likes so far, and her own experiences after complications of a hysterectomy to remove Essure fragments landed her in the emergency room with sepsis.
"The (ER doctors) had to go Google Essure," Garcia said.
Over time, the group has collected a list of about 30 doctors throughout the U.S. that multiple women have vouched for on the basis of a complete removal. Still, some women are so eager to have the device removed, "they jump at the first doctor they come across who will do it," Garcia said. “Proper removal is something that really needs to be put in place, and doctors need to take that seriously,” she added.
Essure's Instructions for Use and Patient Information Booklet contain information about removing the device, said Rose Talarico, a spokesperson for Bayer, a multinational pharmaceutical company headquartered in Germany. “As always, physicians must use their sound clinical judgment to determine the best approach for each individual patient,” she added.
“Essure inserts are intended to be left in place permanently,” state those instructions. “Do not remove insert(s) unless patient is experiencing an adverse event(s) associated with its presence, if removal is clinically indicated...or if requested by the patient,” it says.
A physician should use imaging to confirm the location of the coils before attempting to remove them, the instructions state, and several surgical approaches can be used to remove the inserts after they have been placed.
In some cases, physicians can use the thin, lighted tube known as a hysteroscope, which is inserted through the vagina. When hysteroscopic removal isn't possible, Bayer suggests a salpingotomy (cutting into the fallopian tube), a salpingectomy (removing it altogether) or cornual resection (removing the cornual region of the uterus) by way of minimally invasive laparoscopic surgery.
These procedures contrast sharply with Essure's bold marketing as “the only permanent birth control with a nonsurgical procedure.”
FDA regulations stipulate that in general, medical device labels can include information about risks and benefits, as well as instructions for use. That "might include, as appropriate to the device... information about maintaining the device or identifying potential problems with the device," according to the FDA. The agency's latest guidance on Essure, which recommended a boxed warning, suggests but does not require Bayer to "note the types of significant and/or common adverse events that may be associated with the device and its insertion, use, and/or removal procedure."
Bayer's instructions for Essure removal also refer to “gentle traction” as a way of extracting the inserts, although it also warns that stretching the outer coil while removing the device could cause it to fragment.
“It's like grabbing a Slinky and trying to pull it when it's attached to cement,” said Novoa. “It unravels, and it just snaps on you.”
Dr. Shawn Tassone, an OB-GYN in Austin, Texas, who estimated he has removed close to “a couple hundred” Essure devices in patients, said that the best way to remove the device is to use a method that keeps it intact. Pulling on the coil can cause it to shatter into fragments, which Bayer warns in its instructions.
There's “no good data that shows you what the best method would be to remove it,” Tassone said. “Right now it's through case management, and doing a bunch of them, and coming up with a system that seems to have worked.”
Things can still go awry when doctors attempt to remove Essure using surgical procedures that typically don't involve metal micro-coils an inch-and-a-half long.
When clamps, morcellators — a drill-like device with a long thin straw that grinds and sucks up chunks of tissue — and other surgical tools encounter the coils, they can fracture it. In the case of the morcellator, “It's going to grind up this device in little pieces and spread it all over the pelvis,” said Novoa.
FDA consumer advice states that “some women who reported complications have had surgery to remove the device.” Its advice to physicians performing these surgeries is to follow “the updated labeling on the extraction procedure,” said Deborah Kotz, a spokeswoman for the agency.
“The FDA is working interactively with Bayer to address the need for improved physician training,” Kotz added.