“Instrument of Torture”: The Dalkon Shield Disaster

Originally published March 28, 2016, by Planned Parenthood Advocates of Arizona.

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.

In the 1970s, medical devices were not regulated for safety or effectiveness by the Food and Drug Administration (FDA), and there was no federal regulation to stop the false advertising that misrepresented its failure rate. The Dalkon Shield was never tested for safety in animals or humans. Furthermore, Robins did not disclose the addition of copper salts to the Dalkon Shield, fearing that the device would have to be regulated like a drug if copper were recognized as an active substance. Instead, salespeople were instructed to say the Shield contained a “confidential blending of ingredients.” This lack of transparency foreshadowed years of legal obfuscation on the part of Robins.

Not everyone who laid eyes on the Dalkon Shield got a warm and fuzzy feeling from it — those “feet” gave many people the heebie-jeebies. Dorothy Lansing, an ob/gyn from Pennsylvania, derided the Shield in 1974, calling it a “veritable instrument of torture,” a “gruesome looking little device” with “vicious spikes” that made removal very difficult for the doctor, and painful for the user. She refused to offer Shields to her patients.

The “vicious spikes,” however, were not the most malevolent aspect of the Shield’s design. That dubious honor went to the string. Unlike other IUDs, the Dalkon Shield was attached to a string that was composed of hundreds of monofilaments encased in a sheath, all made of nylon — which was known to deteriorate inside the body. The string was knotted at each end but not sealed — Irwin Lerner, Dalkon’s president, thought that the knot would be sufficient to keep bacteria from invading the string. He was wrong, and neither he nor Robins heeded warnings from employees that the string should be subjected to simple experiments to assess safety.

The uterus is supposed to be sterile — but bacteria were able to enter the string through degraded nylon or the unsealed ends and travel from the vagina into the womb inside the sheath, which protected them from the cervical mucus, normally a barrier to bacteria that would enter the uterus. This nylon-encased bacterial expressway could have facilitated countless infections in the womb, which sometimes turned deadly.

In 1973, Dr. C. Donald Christian was the head of the obstetrics and gynecology department at the University of Arizona Medical Center in Tucson, and his advocacy was instrumental in publicizing the Dalkon Shield’s capacity for harm. His department had inserted a Shield in a patient, who nonetheless became pregnant a short time later. Back then, it was common practice to leave an IUD in the uterus during pregnancy, but midway through her pregnancy, the patient came down with flu-like symptoms. Seventy-two hours later, she was dead, after miscarrying her 19-week-old fetus. The cause of death was a widespread bacterial infection that had started in her uterus and spread to other parts of her body.

Dr. Christian started talking to other doctors during his travels, and was astonished to learn that this peculiar constellation of symptoms seemed to be common among Shield users. In the spring of 1973 he contacted the Centers for Disease Control and Prevention, the Food and Drug Administration, and Robins itself. Not satisfied by their responses, he prepared a manuscript called “Maternal Deaths Associated With an Intrauterine Device,” which detailed four deaths and six serious infections in Shield users, and was published in the American Journal of Obstetrics and Gynecology in June 1974.

Even before the publication of Dr. Christian’s article, word had gotten out that the Dalkon Shield might be more dangerous than other IUDs; in May 1974, Planned Parenthood Federation of America banned the Shield and recommended its removal from those who currently used it. The FDA asked Robins to halt distribution of the Shield, but Robins refused, as it would be seen as an admission of guilt in the face of mounting lawsuits. However, the Shield was effectively off the market by the end of 1974, as Robins decided against complying with a patient registry system the FDA wanted them to create.

Robins spent years trying to evade responsibility in the legal system, during which time they perjured themselves and destroyed untold numbers of incriminating documents in defiance of court orders. Finally, in February 1984, while Shield victims in the audience wept, Judge Miles W. Lord excoriated top Robins executives:

It is not enough to say, “I did not know,” “It was not me,” “Look elsewhere.” Time and time again, each of you has used this kind of argument in refusing to acknowledge your responsibility and in pretending to the world that the chief officers and the directors of your gigantic multinational corporation have no responsibility for the company’s acts and omissions.

Under your direction, your company has in fact continued to allow women, tens of thousands of them, to wear this device — a deadly depth charge in their wombs, ready to explode at any time … This is corporate irresponsibility at its meanest.

By the time Dalkon Shields disappeared from the shelves of family planning clinics, no proper assessment of its safety had been performed, but the damage to its public image had been done. Around 4.5 million Dalkon Shields were sold in 80 countries, from Argentina to Zambia. In the United States alone, 18 users died — 15 from septic miscarriages or stillbirths occurring around the second trimester of pregnancy. Overseas, the death toll could have been higher, especially in countries with less access to doctors and antibiotics.

In October 1984, Robins set up a multimillion-dollar program to remove Shields from women who were still wearing them after all those years. Of the more than 400,000 lawsuits filed against Robins, 9,500 were litigated or settled, and Robins declared bankruptcy in 1985. In 1986, it was estimated that 100,000 Americans still had Dalkon Shields installed in their uteruses. That same year, all but one IUD had been taken off the market due to the plummeting popularity of that particular form of contraception.

It took a couple of decades for the collective trauma of the Dalkon Shield disaster to fade from the public’s consciousness, and contemporary IUDs are one of the most effective birth-control methods out there, with failure rates of less than 1 percent. Even better, their safety and efficacy are subjected to much higher scrutiny by the FDA, which in 1976 was finally empowered to regulate medical devices like IUDs. They’re even the most popular type of birth control among female health care providers, and the general population is following suit, with more and more women choosing IUDs over other types of birth control every day.

Planned Parenthood providers can answer any questions you have about the safety and effectiveness of any birth-control method, including the IUD. Contact your local Planned Parenthood health center for an appointment!