“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.

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.

Dalkon Shield protestRobins 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!

15 thoughts on ““Instrument of Torture”: The Dalkon Shield Disaster

  1. I had one of these devices fitted in the 1970s for 2 years, I am now 80 years of age, in 2003 I had to have a polyp removed, yesterday 22nd march 2017 I had to have another polyp removed, I am awaiting results of a biopsy for this, to see if there is anything else there. Do you think these problems relate to the dalkon shield?

  2. I used that IUD in my early 20s thank god i had a son when i was 18. after useing this I UD IWas never able to have kids again. They gave me money not much i suffer all of my life not feeling like a whole woman. they should have payed me for the rest of my life.not only me but every woman that got hurt

  3. I had the Dalcon Shield implanted when I was 16 under my mother’s supervision. When I was 19 it caused an infection that hospitalized me for a week and not only left me sterile but caused me to reach early menopause. I was never compensated in any way because I didn’t have the funds to participate in the class action law suit. I should have sued them before they filed for bankruptcy. My life was ruined by this IUD

    • It makes me sad you never got compensated ☹️. A.H. Robins (the Dalkon Shield manufacturer) opened a trust to settle claims, but it closed back in 2000. There’s no amount of money they could payout to “fix” what they did to so many women.

  4. My mom had the delkon shield in when she became pregnant with triplets she miscarried one child. Now she has had multiple female cancers I believe were from this horrid device.

  5. I had the Dalkon shield inserted in 1973. In 1975 I became pregnant and developed a very bad infection. The doctor never made it clear if it was a uterine or vaginal infection. It was bad! He removed the shield and I had bleeding during that pregnancy. My baby was delivered by C section because I was having very weak contractions for many hours and developed a low grade fever. My baby was sickly from the very beginning but the doctors and nurses kept telling me she was sleepy because she was a C section baby. I knew something was wrong, but no one listened to me. I came home with the baby and she would not take any nourishment and became weaker and weaker. She was septic and died two weeks later of infection. I’m sure it was the Dalkon Shield but did not have it in me to pursue any sort of legal action. The manufacturers of this device were criminals without a conscience.

  6. I woold like to know if I am covered by the lawsuits for the dalkon shield use. I was in my early twenties when I had it inserted. In the beginning I was sent one payment of 725 dollars. By the time I had it taken out I was full of ovarian cysts and had a hysterectomy and infection along with it. I had no more children which I still regret. I need help and some Information. Thank you. Julie rollman

  7. I had this when I was 16. In 1974. I was pregnant and forced by my parents to have a abortion. Two weeks later she took me for a IUD. It hurt as soon as the Dr put it in. I went back multiple times over a period of 5 months and the Dr kept saying it couldn’t be that bad and give my body time to adjust to it. I finally went to a different Dr to have it removed. I had horrible pain and periods from then on. I also had two surgeries to remove many cysts. I married at 18 and never used birth control. I became pregnant at 20. My pregnancy was terrible and I delivered my daughter at 27 weeks. She was just under two pounds. She lived but with brain damage. She has severe cerebral palsy. Today she is 40. She has never walked, or dressed herself, or been able to care for herself. She is 100% dependent on others. I had three children. I lived with pelvic pain for years. At age 32 my dr advised me to have a hysterectomy. And I did. It stopped the pain and suffering but nothing will change the life my daughter was cheated out of. Nor help the high cost of living as normal as possible when disabled. My biggest fear is when I die my daughter who is mentally high functioning will be placed in a Medicaid nursing home. These are the lowest of the worse care given homes.

  8. I had this put in me in 1972 after I had my twins. I never got my first period and was pregnant again. I had a miscarriage and passed 3 clots. I had to have a D&C and they said they didn’t see the IUD. They thought it must have come out with the miscarriage. I recently had some bleeding problems and had to have a CT scan. They saw a strange object on my stomach. It had jagged edges. Ater asking if I had surgery on my stomach and I said “no”,; they asked if I had an IUD put in. I said I did in 1972. We now know that the Dalkon Shield is still in my body. On November 26th, I will be getting a hysterectomy and they will be trying to get this terrible thing out of me.

    • No. Endometrial polyps are the most common reason for postmenopausal bleeding leading to a biopsy. They have no association to previous use of any IUD. The only medical health related correlation is obesity.

  9. Luckily, I used oral contraceptives because of the bad press and the fact I was very sexually active. It was the 70’s after all 😉 The string of any type disrupts the cervical plug that protects the womb from the vagina. That’s why monogamy is essential for both parties I am sincerely sorry for those negatively effected. Reminds me of the Rely tampon and toxic shock Currently get your 12 year olds vaccinated for HPV. Thanks to planned parenthood for removing an HPV Cancer right before it spread I was 22yo

  10. Following an abortion at 16 and difficulties using the Pill, I had a Dalkon Shield i.u.d. when I was 17 in 1974. When I became pregnant, my doctor said the i.u.d. could remain in place during the duration of my pregnancy. Then the reports of deaths from the Dalkon Shield came out, and he informed me we would need to remove the device. He said there was an 80% chance I would lose my baby. I was 4 months along. Luckily my i.u.d. was being pushed out by my pregnancy and was removed easily. I spotted for a few days, but carried my healthy daughter to term. I was very lucky.

  11. I had the Dalkan Shield inserted three months after the birth of my 2nd child at age 20. Didn’t have to worry about becoming pregnant. All I did was bleed for 4 months straight, when I decided to have it removed. The reason I went in this direction was because I got pregnant while on birth control pills. Never again! I had cramping the whole time and it made me completely miserable.

  12. I was sterilized in April 1978 about six months after getting a Dalkon Shield. I was 19. Not only wasn’t this mentioned as one of the possible causes of my problem, I was told that my “lifestyle was going to cause even more bad things to come my way.” I had been molested by my father prior to puberty, and had a lot to go through. It’s horrifying to realize that if a bunch of people had been braver, and more ethical, being sterilized at age 19 wouldn’t have had to be part of all I had to work through.

  13. In early 1970’s, I too had Dalton copper IUD installed, less than a couple of months, I woke in the middle of the night – hemorrhaging .. the ER doctor removed it and put me on antibiotics. The infection never went away and my geno put me on a 30 day antibiotic supply.
    After a D and C and more antibiotics.. I have had nothing but reproductive organ problems from more ectopic pregnancy, my one F. tube ruptured.
    During my last 3 pregnancies, I had what is know as Bracts Hicks and I developed cystic ovoers so bad they removed both… was on estrogens pills for 13 years… next they removed my uterus due to massive tumours inside, outside and in the walls that started to ruptured a few hours before the surgery was to take place..
    meanwhile I developed IBS….
    Now at the age of 72, I suffer from atrial fibulations.. .. and being treated…
    ask me if I would use any type of IUD in my next life time.. I will tell them to stick, you know where!!!

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