From the Dalkon Shield to Britney’s IUD

The answer is that the reproductive health of people who can get pregnant is simply not a high enough priority in our society. We settle for good enough when we could have great. 

Last week Britney Spears described how under her conservatorship, she was required to be fitted with an intrauterine device and is prohibited from removing it without her father’s permission or the permission of the court. Presumably the goal was to stop Ms. Spears from becoming pregnant with additional children without the express authorization of her custodian. 

Britney Spears from her Instagram Page.

There are many discussions to have about Ms. Spears’ rights, disability rights, and forced reproductive control. The topic is an intersectional minefield. An amazing discussion with a journalist who is an expert in the field and who has a disability was broadcast on What Next this week. My own thoughts on the subject would require me to use profanity on a blog that I know is read by my program manager at the NIH, and when I resort to profanity, that usually means I am out of comfortable intellectual waters. What I can discuss with a fair amount of authority is the IUD itself, its history in modern times, and how it has succeeded and failed as a medical device for people who want to avoid pregnancy. 

If you are my age (49) or older, you first learned about the IUD from horror stories told about the Dalkon Shield. The Dalkon Shield was an IUD invented in the early 1970’s by a gynecologist. Hugh J. Davis, was known as an intellectually arrogant person who didnt take criticism well.  So, it wasn’t a very inclusive design team – just one man. He later recruited Irwin Lerner, an electrical engineer, to help him finalize and market the device.  The device was rushed to market with insufficient clinical data, and the inventors published their pre-market data without acknowledging their financial interests in the device. They sold the device design to the A.H. Robins company, and Davis continued to act as a consultant and proponent of the device for many years. 

At the time, the birth control was popular, but the high levels of hormones in those pills were concerning to many.  The side effects of the pill were and still are troublesome and sometimes very serious. In the 1970’s, the available pills nearly 100 times more progestin and 3 to five times as much estrogen as what typical combination pills contain today.  Second, and probably more important, is the fact that the A.H. Robbins company did something new that we now take for granted: they marketed the ever loving heck out of that device. 

Dalkon Shield Marketing Material

Before 1976, you could invent and patent a new medical device that was meant to be inserted inside a uterus and worn for years at a time with absolutely no federal oversight. As a result, there were no regulations that limited or specified the set of materials to be used to construct the device. So, when the company decided to use a new material for the string, they were able to make that change without consulting any oversight body or performing additional testing to make sure that it was safe. 

It turns out that the filament they used for the string was made up of several smaller filaments, like a cable consisting of several smaller wires wrapped together. The little spaces in between the multi-filament string were small enough to give bacteria from the vagina a pathway into the uterus. These bacteria caused infections in people wearing the device that were later recognized as pelvic inflammatory disease. All told, the Dalkon Shield resulted in the injury of hundreds of thousands of women and the documented deaths of at least 18. 

The Dalkon Shield disaster is why medical devices are now regulated by the FDA, due to a federal law passed in 1976. Prior to 1976, only drugs were regulated. 

As a result of the Dalkon Shield injuries, deaths, and related lawsuits and finally recall, IUDs fell out of fashion in the US. Even though many other non-Dalkon devices existed, the market for IUDs was non-existent. The FDA approved the first new generation IUD in 1984, and that device was available in the US in 1988. Then several years passed before the current crop of modern IUDs began to come on the market from 2001-2016. These are considered Class III medical devices and require pre-market approval before they can be sold in the US. 

If a device failure occurs, doctors and patients are encouraged to report the failure to the FDA. Only distributors and manufacturers are required to report. The FDA compiles a database of these failures and though the reporting system is largely voluntary, the FDA does investigate to see if they are part of a pattern. Even the devices containing copper are considered to contain a drug, so must undergo stricter regulations required of drug/device combination products. Most agree that this has led to a very safe but short list of new generation IUDs available in the US. The downside of this enhanced regulation is that many devices approved in other countries that may be more appropriate for some people are not available here. The cost of obtaining FDA approval is too high to make selling in the US market attractive to foreign manufacturers. 

The stain of the Dalkon Shield has faded a bit. Younger people are more likely to seek and IUD as a long-term reversible form of birth control.  However, the legacy of birth control designed, developed, and marketed by people who cannot become pregnant is still a part of medical care today.  All the highly effective birth control methods have undesirable side effects. (Well, maybe not vasectomies, but that requires a monogamous relationship with someone with a good amount of self-knowledge and foresight for maximum efficacy – a rare situation). 

Everyone else must figure out what side effects and inconveniences we are willing to deal with to manage when we do and do not want to bear children, if at all. Why is the situation so dire? Why do we take the pill and risk life threatening blood clots at rates that are higher than those that temporarily stopped the use of some vaccines during a global pandemic? The answer is that the reproductive health of people who can get pregnant is simply not a high enough priority in our society. We settle for good enough when we could have great. 

One way to make better contraceptive choices a priority is to have people who can become pregnant directly involved with the design and development of contraceptive devices. Involved from the earliest stages. We need the viewpoints of these people as patients and as clinicians, designers, and engineers.  And we all need to think just a little more about each other’s healthcare. 

Simply, when the people who are the main users of a technology are not consulted in the design phase of that technology, the results for the end users are subpar and sometimes outright harmful. 

Diverse teams can save lives.   

As for Ms. Spears, it seems clear that her autonomy has been robbed without due process. Since you cannot remove an IUD on your own, she is effectively at the mercy of the state with respect to her ability to bear more children. Medical science may have given her a safer device than was available in the 70’s, but disability law has kept her rights in the 1920’s.

Author: Catherine Klapperich

Find me on Twitter @DrKlapperich

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