Essure — the Permanent Coils That Perforated Organs and Cost $1.6 Billion

When Bayer announced on 20 July 2018 that it would stop selling Essure in the United States by year’s end, it framed the decision as a business matter — declining sales, a shrinking permanent-contraception market — and insisted, in writing, that “the benefit-risk profile of Essure has not changed” and that the device’s safety and efficacy were “demonstrated by an extensive body of research.” The gap between that claim and the lived record was already vast: by then the FDA had logged tens of thousands of adverse-event reports, a 2016 boxed warning sat on the label, an April 2018 order had restricted who could sell the device at all, and roughly 39,000 U.S. women would ultimately file claims describing perforated organs, coils that migrated into the abdomen, chronic pelvic pain, autoimmune reactions, and failed sterilizations. The wonder-device — sold as the only FDA-approved permanent birth control requiring no incision, no general anesthesia, and no hormones — was being withdrawn for “business reasons” precisely because the harm had made the business untenable.

Essure was a pair of nickel-titanium and stainless-steel microcoils wound with polyethylene terephthalate (PET) fibers. A clinician threaded one into each fallopian tube through the cervix; the PET fibers provoked a deliberate inflammatory response, and over roughly three months scar tissue was meant to occlude the tubes permanently. The premise was elegant and the marketing matched it: a fifteen-minute office procedure, immediate return to normal activity, “99.83% effective.” The same biology that produced occlusion, however, also produced the harm. Coils perforated the thin tubal wall; fragments and whole devices migrated into the pelvis and abdomen, sometimes requiring hysterectomy to retrieve; nickel-sensitive women reacted systemically; and the occlusion was incomplete often enough to yield unintended and ectopic pregnancies.

Conceptus Inc. won FDA premarket approval (PMA P020014) in November 2002 on the strength of two non-randomized pivotal trials with no comparison arm and incomplete long-term follow-up. Bayer acquired Conceptus in 2013 for roughly $1.1 billion, inheriting both the product and a rising tide of complaints. The reckoning came not from a recall but from data the manufacturer had not generated: patient registries, a mass Facebook group (“Essure Problems”) tens of thousands strong, an independent analyst’s mining of the FDA’s MAUDE database surfacing hundreds of reported fetal losses, and a congressman’s bill to revoke the approval. The FDA imposed a boxed warning and a mandatory postmarket study in 2016, restricted sales in 2018, and watched Bayer withdraw the device worldwide by 31 December 2018 — without ever recalling the coils already inside three-quarters of a million bodies. In August 2020 Bayer agreed to pay roughly $1.6 billion to resolve about 90 percent of the U.S. claims, while still denying the device was defective.