“Instrument of Torture”: The Dalkon Shield Disaster

This Dalkon Shield is archived at the Dittrick Medical History Center and Museum at Case Western Reserve University. Photo: Jamie Chung

This Dalkon Shield is archived at Case Western Reserve University. Photo: Jamie Chung

These days, IUDs, or intrauterine devices, have stellar reputations as highly effective contraceptives. Along with implants, IUDs can be more effective than permanent sterilization, and their safety record is fantastic. We also have powerful regulations in place to keep dangerous medical devices off the market, and the FTC can keep manufacturers from making false claims in advertising.

But a previous generation of birth-control users might associate IUDs with dangerous pelvic infections and miscarriages. That’s because a single device, called the Dalkon Shield, almost single-handedly destroyed an entire generation’s trust in IUDs. At the time of its debut, there were dozens of IUDs on the market — but the Dalkon Shield unfairly tainted the reputation of all of them. With no FDA or FTC regulations reining in untested devices or false advertising, women in the late 1960s and early 1970s didn’t enjoy the protections that we take for granted today. And it was actually the Dalkon Shield’s string, which was made with a material and by a method that hasn’t been used in IUDs before or since, that made it dangerous.

Today, IUDs are the most popular form of contraception among physicians wishing to avoid pregnancy.

We’ve known about IUDs for more than a century, and have made them out of ebony, ivory, glass, gold, pewter, wood, wool, and even diamond-studded platinum. These days, IUDs release hormones or spermicidal copper ions, but these older devices were simply objects inserted into the uterus that acted as irritants, possibly enlisting the immune system to kill sperm. They were not as effective as modern-day IUDs.

The Dalkon Shield was invented in 1968, was made primarily of plastic, and had “feet” — four or five on each side — to prevent expulsion. In 1970, after being marketed independently, it was sold to family-owned pharmaceutical giant A.H. Robins Company, of Robitussin fame. It was manufactured in the same factory where ChapStick was produced, and retailed for $4.35.

Dr. Hugh J. Davis, the Dalkon Shield’s primary inventor, claimed that users of his device had a 1.1 percent pregnancy rate — but that number was based on a small, methodologically flawed study conducted over eight months. In fact, the Dalkon Shield had a 5.5 percent failure rate over the course of a year. The fact that the Shield didn’t provide high protection against pregnancy was a huge problem, but its design also dramatically increased risk for pregnancy complications. Of the tens of thousands of users who became pregnant while wearing the Dalkon Shield, 60 percent of them had miscarriages. Continue reading