Global Health Embarrassments: The Dalkon Shield

The sale and distribution of the Dalkon Shield IUD is one of the most shameful incidents in the history of global health. It was a badly designed, dangerous contraceptive device that caused harm to a shocking number of women that used it. It was taken off the market in the United States, and the US government continued to ship it to the developing world as part of global health assistance.

The IUD was a perfect combination of terrible features. Its long string wicked bacteria from the vagina to the uterus with amazing efficiency. The device itself burrowed into the uterine wall, traumatizing the tissue there. It was marketed based on a falsified study run by a researcher with a financial interest in the product.

The Dalkon shield went on the market in the US in 1971. On year later, word had gotten out that it was much more dangerous than other IUDs, sales were declining in the US, and the manufacturer was receiving complaints.

Here's something I learned researching this article. The Dalkon shield may not have been worse than any other IUD of that era. While some studies found an elevated risk of pelvic inflammatory disease, others found that if inserted by an experienced clinician, it was a safe and effective method of birth control. But that didn't matter, because by 1972, nobody wanted the Dalkon shield. Both women and doctors were afraid of it.

At this point, some manufacturers might have taken the device off the market, revised its design, or provided additional warnings an advice to physicians. The A.H. Robins company opted to advertise, and cut prices on volume sales.

This is where it becomes a global health embarrassment. The United States Agency for International Development, or USAID, was one of the volume purchasers. It shipped two million Dalkon shields to the developing world. USAID took an already questionable product and made it worse. IUDs need to be sterile when inserted, or they cause infection. Most of the Dalkon shields were shipped unsterilized; they were supposed to be sterilized by the provider before insertion. I am not sure how providers were supposed to know that, since they only shipped one English-language instruction book per 1000 IUDs. They also only shipped one inserter for each ten IUDs, pretty much guaranteeing cross-contamination among patients.