The Consumer's Guide to Essure Birth Control

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Ruth Wilson says it was a group of women she found on Facebook that helped her trace the bizarre symptoms she was experiencing—severe migraines, inexplicable weight gain, the constant taste of metal in her mouth—to the permanent birth control device she’d had implanted after the birth of her second child. Her doctors had suggested the problem was “in her head.”

But the women of Facebook knew better. They’d had the same device implanted in their bodies as Wilson had: the Essure System for Permanent Birth Control, made by Bayer. They’d suffered symptoms like hers, and many that were far worse—severe pain, heavy bleeding, life-altering autoimmune disorders.

Answers to Key Questions:

• What to Know If You're Considering Essure
• What to Know If You're Thinking About Having It Removed

Like her, they had been to numerous doctors. And like her, their concerns had been brushed aside. But in talking to each other, to doctors, and eventually to federal regulators, they had grown confident that the problem was not in their heads. It was lodged in their fallopian tubes.

Essure is a permanent birth control device that consists of two small metal coils inserted through the vagina into the fallopian tubes (see image, below). The device is popular among women and physicians because it offers a way—the only way—to get sterilized without surgery or anesthesia. Since Essure first came to market in 2002, upward of half a million women have been implanted with it, the majority of them in the U.S.

But as a steady beat of media reports have pointed out—the most recent from the Washington Post Magazine—thousands of these women say they have suffered serious side effects and medical complications as a result of this product. And, like Wilson, many of them say they were left in the lurch by their doctors when they sought help.

“Doctors have been slow to recognize the trouble with Essure, and in many cases unprepared to treat women who want or need the device removed,” says Lisa McGiffert, director of Consumer Reports’ Safe Patient Project. “That’s a huge problem for consumers because the medical issues associated with this device can be quite serious.”

The available data suggest that the overall complication rate for Essure is low; just 3 to 4 percent of women who have the device implanted report problems. But according to an independent analysis of the Food and Drug Administration’s database, conducted for Consumer Reports by the company Device Events, within that subgroup the problems are indeed serious. Roughly half of the almost 17,000 adverse-event reports involving Essure indicate that surgery—up to and including full hysterectomy—was needed to resolve the problem.

The FDA has taken several steps to address Essure safety concerns: It has added a black box warning to the product’s packaging; helped Bayer to create a comprehensive, optional patient safety checklist that doctors can use to advise women of the potential risks; and called for additional multiyear clinical trials into the device’s safety—the results of which won’t be ready until 2023.

But despite these measures—or perhaps because of them—the picture for consumers is now muddier than ever: Even after acknowledging the need for further study, the FDA has opted to keep Essure on the market. And even with a list of risks that include punctured organs, ectopic pregnancies, and severe allergic reactions, the FDA and the American College of Obstetricians and Gynecologists have supported Essure as an option for women seeking to permanently prevent pregnancy.

Those conflicting messages have left consumers like Wilson to grapple with questions that no headline or federal edict has managed to resolve: How should women weigh the high-profile concerns over Essure’s safety against their own doctors’ assurances? Knowing now how many things can go wrong with this device, is it ever the right choice? And if you’ve already had Essure implanted in your body, what should you do now?

To answer those questions, Consumer Reports spoke with doctors, patients, safety advocates, federal regulators and the device-maker Bayer. Here’s what you need to know and the questions to ask, to make the safest and most educated choice for your health.

When Complications Arise

Doctors who implant Essure are given multiple practice runs on a simulator and must complete five successful implant procedures under the observation of a Bayer-trained employee in order to become Bayer-certified.

But anecdotal evidence suggests that this level of training may not be enough. For example, doctors experienced in Essure removal say that they have at times found multiple coils per fallopian tube. “We think that when the coil doesn’t go in right on the first try, or if the doc thinks it didn’t go in right, he just implants another, and another,” says Julio Novoa, an OB-GYN who has seen scores of patients for Essure-related complications. “I have found as many as five in one person.”

Addressing Essure-related medical concerns can be difficult for several reasons. One is that the complications and symptoms that have been attributed to this device are so numerous and diverse that a consumer might turn to any number of specialists—an allergist, an endocrinologist, a primary care doctor, an emergency room physician—for treatment; and not all of those doctors will be familiar with Essure or aware of its potential role in causing symptoms.

“We have women writhing in pain, going to the ER with punctured organs, and the docs there have to Google Essure to find out what it even is,” Novoa says.

But several doctors we interviewed say that even their colleagues who know what Essure is—including those who implant the device themselves—don’t necessarily know how to respond to complications.

And according to Amanda Rusmisell, a legislative liaison for the Essure Problems advocacy group, many of those doctors are unwilling to even try. “So many women in our group have gone back to the doctors who handled their Essure implants, only to be told that the doctor doesn’t offer removal services,” Rusmisell says. “It’s a very frustrating and scary place to be: They have this thing in their bodies that’s making them sick, and none of the doctors they talk to know what to do.” 

The Risks of Removal

Part of the problem is the device itself. Essure consists of two 1.5-inch-long metal coils that are implanted through the vagina into the fallopian tubes. The coils are designed to trigger an immune response that causes scar tissue to form around them.

In about three months, the scar tissue is supposed to block the tubes so that eggs cannot descend from the ovaries into the uterus to be fertilized. That blockage is meant to be permanent. The coils were not designed to be removed from the body; when pulled in the wrong way they can send bits of metal and plastic into the abdomen.

The other problem, though, is a lack of training. Doctors who implant Essure are not given any hands-on training in how to safely remove the device, should the need arise.

According to Bayer, that is as it should be. The company says that it has resources for doctors who are unsure how to deal with removal requests but that ultimately, the right procedure is going to depend on individual case details and the physician’s own clinical judgment. “Gynecologists are surgeons,” says Patricia Carney, M.D., Bayer’s director of U.S. Medical Affairs, Women’s Health. “They are accustomed to doing surgery in all parts of the abdominal cavity. And removal of an Essure device that’s in the abdominal cavity really isn’t any different.”

Expert Advice and Questions to Ask If You’re Considering Essure

1. What are the risks? As the FDA’s black box warning acknowledges, some women implanted with the Essure System for Permanent Birth Control have experienced a range of adverse events, including perforation of the uterus or fallopian tubes, migration of the coils into the pelvic or abdominal cavity, persistent pain, and allergic or autoimmune responses. In some cases, those symptoms have necessitated surgery to remove the coils.

No one knows for sure why some women develop complications, but experts believe that a history of certain conditions, including endometriosis and chronic pain, may increase the risk. If you are considering Essure, ask your doctor to go over Bayer’s patient checklist with you, which describes the risks, before making a decision. (The checklist is not mandatory for doctors, but Consumer Reports thinks it should be.)

You should also get tested for nickel and other metal allergies. Such tests won’t tell you conclusively whether Essure will cause you problems, but if it turns out you have a severe nickel allergy, you’ll want to skip this device and consider other options.

2. How experienced is the doctor? Ask how many Essure implants your doctor has done and whether his patients have had any complications. In clinical trials doctors were unable to properly insert the coils in both fallopian tubes 14 percent of the time. And in subsequent studies from independent researchers, improper coil placement was a leading cause of complications.

Marisa Adelman, M.D., an OB-GYN who has studied Essure, says that her rule is to stop the procedure altogether if the placement doesn’t happen easily or if there’s a feeling of needing to force the device into place. Let your doctor know beforehand that if the device doesn’t slide in easily you’re okay with her stopping the procedure.

3. Will the doctor remove the device if complications arise?
The Essure coils were designed to remain in the body for life, and removal may be difficult. Though doctors who implant Essure are trained and certified by Bayer, there is no hands-on training for removal surgery nor any consensus about the best or safest way to extract the coils.

Anecdotal evidence suggests, and patient-safety advocates report, that many women who experience problems with Essure have a hard time finding a doctor willing or knowledgeable enough to remove the device. Ask whether your doctor has had to do any removals. If he or she has, ask how many removal procedures and whether they were successful. An expert we spoke with estimates that it takes about 20 to become proficient.

4. What are my other options? Adelman and other experts CR spoke with say that because of the risks posed by Essure, most women considering permanent or long-term contraception should first consider other options, including:

• Having your tubes tied (tubal ligation). This can be performed as an outpatient surgery with a minimally invasive, laparoscopic procedure. Like any surgery, this one carries a small risk of hemorrhage, Adelman says. But a 2015 study in the British Medical Journal compared Essure sterilization with tubal ligation and found that patients receiving Essure were 10 times more likely to need another surgery within a year of the procedure.

• Intrauterine devices (IUDs). They’re placed in the uterus in a simple, in-office procedure. They come in hormonal and nonhormonal forms, and can remain in place for three to 12 years, depending on which type you choose. When it’s time for your IUD to come out, a replacement IUD can be immediately inserted in the same doctor’s visit—a cycle that could continue until menopause. IUDs pose a slight risk of expulsion, especially in the first three months after placement. That’s similar to the risk of Essure expulsion (up to 3 percent), but unlike Essure, IUDs are designed to be removed from the body, and the resulting medical complications tend to be far less severe.

• Vasectomy. It’s an option to consider if you’re making a choice about sterilization along with your partner. Amanda Yunker, an associate professor of obstetrics and gynecology at Vanderbilt University Medical Center, wishes vasectomy would be a greater part of the discussion about sterilization for couples because the procedure, which involves cutting or blocking the vas deferens so that sperm cannot reach a man’s semen, is much simpler and safer than any female sterilization procedure. Vasectomy is done in-office and generally has a very short recovery time. The surgery carries a small risk of infection.

What You Need to Know If You’re Considering Essure Removal

1. Watch for symptoms. If you already have the coils implanted, familiarize yourself with the roster of complaints among Essure consumers, which include:

• Allergic reactions such as rashes, itching, hives, and swelling, or even more severe symptoms that indicate you may have developed an autoimmune condition. Autoimmunity occurs when the body attacks its own cells and tissues; symptoms depend on which organs are affected and can include hair loss, joint pain, fatigue, and other maladies that may come and go in bursts.

• Pain or bleeding that lasts more than a few days post-surgery. This can be a sign that the coils have not been properly placed in the fallopian tubes, have perforated an organ, or have migrated into the uterus or abdomen. If your pain persists, ask your doctor to verify, through X-ray or ultrasound, the location of your coils.

2. Rule out other causes. Your doctor should do a full work-up to rule out other possible causes of your symptoms before drawing any conclusions. If the symptoms started after you had the Essure device inserted, or if an exam is inconclusive and you still want your coils out, ask about removal surgery.  

3. Find a doctor experienced in removing the devices. If your own doctor has not done many removals, you may want to search for someone with more experience. A good place to start is the Essure Problems group website; it’s not run by any medical authority, but it does contain a short list of doctors who have experience with removal and who may either be able to treat you or refer you to someone with appropriate experience.

4. Know your options. In some cases doctors can take the coils out the same way they were inserted: with a thin, lighted tube that is inserted through the vagina and has a camera at the end. This procedure, called hysteroscopic removal, is the least invasive removal option but is typically possible only within the first few weeks after the coils are implanted, before scar tissue has a chance to form.

The remaining options all involve surgery: either cutting open the fallopian tubes to remove the coils, removing the fallopian tubes altogether, or removing the entire uterus (hysterectomy).

A full hysterectomy, which involves removing the uterus and cervix, can sound and feel like an extreme measure, especially for women who chose Essure because they wanted to avoid having an organ-removal surgery. But doctors we spoke with said that it is the most common of the surgical options and, in many cases, the safest (in part because it is a familiar procedure and in part because it allows them to avoid pulling on or manipulating the coils directly).  

5. Prepare for surgery. Regardless of which procedure you undergo, your doctor should first order an X-ray and ultrasound to confirm the coils’ locations in the body. And if you’ve switched doctors for your removal procedure, make sure your new doctor has all the records from your previous doctor.

6. Say no to the morcellator. A morcellator is a surgical device that is sometimes used to grind up uterine tissue so that it can be extracted from the smallest possible incision. With Essure removal, though, the morcellator can inadvertently shred coil fragments and fibers and disperse them throughout the body. Some doctors have been known to use the morcellator in Essure removal operations. Make sure yours does not.  

With additional reporting by Catherine Roberts and Thomas Germain.

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