When the A.H. Robins Company pulled the Dalkon Shield from the U.S. market on June 28, 1974, the gap between what its inventor Dr. Hugh J. Davis had promised and what the device delivered was already measured in dead women: Davis had published a February 1970 study claiming a 1.1 percent pregnancy rate — comparable to the contraceptive pill and better than rival IUDs then quoting 2 to 3 percent — while concealing that he held a financial stake in the product, had followed roughly 640 patients for an average of only 5.5 months, told many of them to use backup contraception during the early cycles, and dropped non-compliant women from the count. Properly designed studies later put the real failure rate at 5 to 10 percent. By the time Robins acquired the device for $750,000 plus royalties in June 1970 and began mass-marketing it in January 1971, the wonder-IUD legend was built on a number its own inventor had manufactured.
The harm was not contraceptive failure alone. The Shield’s distinguishing feature — a multifilament Supramid removal string sheathed in nylon — acted as a wick, drawing bacteria from the vagina past the cervix into the sterile uterus. Women who conceived with the device in place frequently miscarried in the second trimester via septic abortion, an infected and sometimes fatal mid-pregnancy loss; survivors of pelvic inflammatory disease were often left with scarred fallopian tubes and permanent sterility. Roughly 4.5 million units were sold across 80 countries before withdrawal, about 2.5 million of them in the United States. At least seventeen American women died, and hundreds of thousands suffered PID, ectopic pregnancy, or infertility — a casualty pattern with no precedent in modern contraception.
Robins did not recall the devices already inside women’s bodies, and continued overseas distribution after halting U.S. sales. Litigation — not regulation — forced the truth into the open: discovery in cases tried before federal judges Miles W. Lord in Minnesota and later Robert R. Merhige Jr. in Virginia exposed internal memos showing the company had grounds to know of the wicking defect by 1971 and buried them. Facing a litigation tide it could not absorb, Robins filed for Chapter 11 bankruptcy in August 1985. Judge Merhige fixed its liability at $2.475 billion, funded by acquirer American Home Products into the Dalkon Shield Claimants Trust, which processed roughly 200,000 claims. The episode became the proximate political fuel for the 1976 Medical Device Amendments — the first U.S. law to require pre-market review of medical devices — making the Dalkon Shield the catastrophe that wrote the rulebook it had evaded.
When the U.S. Food and Drug Administration ordered Boston Scientific and Coloplast on April 16, 2019 to stop selling all surgical mesh intended for transvaginal repair of pelvic organ prolapse, the gap between the promise and the harm was already a settled scientific finding: the agency stated the manufacturers had “not demonstrated a reasonable assurance of safety and effectiveness,” having “failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh.” The mesh had been sold for nearly two decades as a stronger, more durable fix for sagging pelvic organs. The controlled evidence showed it was no better than stitching native tissue — and considerably more dangerous.
The product was a knitted sheet of non-absorbable polypropylene, placed through the vagina to act as a hammock under a prolapsed bladder, uterus or rectum. Its central failure mode was that the implant did not stay inert. Over months and years the mesh contracted, hardened and eroded through the vaginal wall and into adjacent organs, producing a signature cluster of harms: chronic pelvic pain, dyspareunia (painful intercourse), bleeding, infection, urinary problems, organ perforation, and erosion that frequently could not be fully reversed because the mesh integrated into tissue and fragmented on removal. The FDA’s own reviews put serious complications well above the “rare” reassurance physicians had been given.
The devices reached the market not through clinical proof but through the 510(k) clearance pathway, which lets a manufacturer skip pre-market testing by claiming “substantial equivalence” to an existing product — in this case an older abdominal hernia mesh and the first transvaginal kits, each in turn cleared by pointing back to a predecessor. No randomized trial of safety and effectiveness was ever required to put these implants into women. The reckoning came in two channels at once. Litigation consolidated into one of the largest mass-tort proceedings in U.S. history — more than 100,000 lawsuits against Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, C.R. Bard, Coloplast and others, resolved for upward of $8 billion. Regulation moved more slowly: a 2008 public-health notification, a blunt 2011 reversal (“not rare”), reclassification to Class III in January 2016, and finally the 2019 stop-sale order when no maker could produce the safety data the new class demanded. Transvaginal POP mesh became the textbook case of a permanent implant cleared without proof and withdrawn only after the evidence — and the bodies — caught up.
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.