No clinical study has tracked Essure’s effectiveness out to 15 years. The longest manufacturer-sponsored trial followed patients for 10 years and reported a pregnancy rate of 0.78%. That number is reassuring on the surface, but it doesn’t tell the whole story, especially for the many women who still have the device in place years after it was pulled from the U.S. market in 2018.
What the 10-Year Data Actually Shows
The FDA-mandated post-approval study of Essure tracked patients for a decade after placement. At the end of that period, the overall pregnancy rate was 0.78%. That puts it in roughly the same range as traditional tubal ligation over a similar timeframe. A large comparative study found that at five years, cumulative pregnancy rates were 6.26% after Essure and 7.22% after surgical tubal ligation, suggesting Essure performed slightly better in preventing pregnancy during that window.
But those numbers come with caveats. The 10-year study also found that nearly one in five participants, 19.5%, had the device removed for any reason before the study ended. When a significant portion of participants leave a study early, the remaining effectiveness data becomes less reliable. Women who experienced problems were removed from the pool, which can make the device look more effective than it is in a real-world population.
Why 15-Year Data Doesn’t Exist
Essure received FDA approval in 2002 and was voluntarily withdrawn from the U.S. market by Bayer at the end of 2018 following years of patient complaints, adverse event reports, and increasing regulatory scrutiny. The longest clinical follow-up was designed for 10 years, and no extension studies were conducted. So if you’re 15 years out from your Essure placement, you’re in uncharted territory from a clinical evidence standpoint.
That said, the device works by prompting scar tissue to grow around small metal coils placed in the fallopian tubes. Once that scar tissue fully blocks the tubes, the mechanism of action is permanent. There’s no biological reason the blockage would reverse itself over time. The concern isn’t that scar tissue dissolves. It’s that in some cases, scar tissue never fully sealed the tubes in the first place, or the coils shifted position after placement.
When Essure Fails
The FDA received 4,629 reports of pregnancies in women with Essure between 2002 and 2024. Among the 2,346 reported pregnancy losses in that group, 601 were ectopic pregnancies, where the embryo implants outside the uterus. That’s a disproportionately high rate of ectopic pregnancy and reflects the fact that partially blocked tubes create the perfect conditions for one.
A study of 103 unplanned pregnancies after Essure placement found that the average time between the procedure and pregnancy was about 20 months, but some pregnancies occurred as late as seven years after placement. Most failures clustered in the first couple of years, which suggests that incomplete tubal blockage, not long-term device degradation, is the primary cause. Still, the fact that pregnancies occurred years later means the risk never fully disappears.
The Confirmation Test Matters
After Essure placement, patients were supposed to return three months later for an imaging test (called an HSG) to confirm the tubes were fully blocked. Among the 103 unplanned pregnancies studied, only 66% of women had actually completed that confirmation test. Skipping it meant some women relied on a device that had never fully worked. Researchers noted, however, that many pregnancies occurred well after the three-month window, meaning even women who followed the protocol weren’t fully protected. If you never had a confirmation test and are now 15 years out without a pregnancy, the device likely formed an effective seal, but this is inference rather than clinical certainty.
Complications Beyond Pregnancy
For many women searching about Essure at the 15-year mark, pregnancy prevention isn’t the only concern. The device contains nickel and other metals, and some women report chronic symptoms they attribute to the implant: pelvic pain, fatigue, joint pain, headaches, and allergic-type reactions. The manufacturer reported a nickel hypersensitivity rate of 0.004%, but patient advocacy groups and thousands of adverse event reports suggest the real-world experience is more complicated.
One published case report documented a delayed systemic allergic skin reaction linked to the nickel in Essure, appearing years after placement. While a causal link between nickel sensitivity and chronic symptoms was never formally established in large studies, the volume of patient complaints was significant enough to drive regulatory action and, ultimately, Bayer’s decision to stop selling the device.
Device migration and perforation, where the coils move from their intended position or poke through the fallopian tube or uterine wall, were also reported to the FDA. These complications can develop gradually and may not cause obvious symptoms for years.
Removal Rates and Options
The 10-year post-approval study reported a cumulative device removal rate of 19.5%. Reasons ranged from pain and bleeding to device migration and patient preference. Removal typically requires surgery, either a procedure to remove the tubes (salpingectomy) or, in some cases, a full hysterectomy if the coils have embedded deeply into surrounding tissue. The complexity of removal depends heavily on where the coils have migrated and how much scar tissue has formed.
Bayer ultimately paid approximately $1.6 billion to resolve around 90% of the nearly 39,000 U.S. claims filed by women alleging device-related injuries. That settlement covers a wide range of reported problems, from chronic pain to unintended pregnancies to complications from removal surgery.
What This Means If You Still Have Essure
If you’ve had Essure in place for 15 years without a pregnancy, the device is very likely providing effective contraception. The scar tissue that formed around the coils is permanent, and there’s no known mechanism for it to reverse. Your risk of an unintended pregnancy at this point is extremely low, though not zero, since no sterilization method carries a true 0% failure rate over a lifetime.
The more relevant question for most women at this stage is whether the device is causing other problems. Symptoms like chronic pelvic pain, unusual bleeding, fatigue, or joint pain that developed after Essure placement are worth discussing with a gynecologist, particularly one experienced with Essure removal. Not every symptom is caused by the device, but given the pattern of complaints and the regulatory history, it’s a reasonable thing to investigate.