The intrauterine device (IUD) has been around, as a form of birth control, for over a thousand years. It is mentioned in the Talmud and in the writings of Hippocrates. It was a well known device, used for its effectiveness and because it could be removed at will. Despite its lengthy history, the science behind why an IUD works is still not fully understood.
In the 1960s, the first plastic IUD was approved by the FDA and hit the U.S. market. In the subsequent years other IUDs followed as the market for the product grew in the face of health concerns about the "Pill." It seemed probable that the IUD would someday replace the Pill as the default birth control method.
At the time the FDA did not require testing of IUDs. The manufacturers would test for effectiveness and little else. In this environment the Dalkon Corporation developed the Dalkon Shield IUD, then sold their design to the A.H. Robins Company. in 1971 the product hit the market with a heavy advertising blitz. There were two designs, a larger one marketed toward mothers and a smaller version for women who had not yet given birth.
There were warning signs early on that problems were inevitable. As with many other companies, the only study conducted on the Dalkon Shield was to test its effectiveness, not safety. The man who created the device, Hugh Davis, M.D., worked on the study himself. In a serious case of conflict of interest, he would receive a percentage of the profits from sales of the IUD. Even before Robins purchased the design, scientists reported problems with the research, which claimed the Dalkon Shield would reduce the rates of infection and expulsion of IUDs. Additionally, the Dalkon Shield had been tested with concurrent use of spermicidal foam, skewing the results about its effectiveness in pregnancy prevention.
The aggressive marketing campaign was a success, with about 2.8 million IUDs sold at its peak. What those users didn't know was that there was a "confidential" memo floating amongst Robin's top officials. The memo indicated that there were problems with the string, meant to allow the woman to "feel" that the device was still in place and for easy removal by a doctor. Other IUDs used a mono-filament nylon string, similar to fishing line. The Dalkon Shield, however, used a "string" comprised of 200-400 individual plastic filaments inside a plastic sheath. The memo indicated that the string had a tendency to break down.
The danger therein lies with the environment of the uterus and vagina. The vagina is constantly moist, harbors numerous naturally occurring bacteria, and is susceptible to outside, non-native bacteria as well. The uterus is a sterile organ, and the string of an IUD bridges the two. In other models of IUDs the link is safe and sealed naturally because of the type of string used. In the Dalkon Shield, the multi-filament string allowed for bacteria to travel into the uterus. To make matters worse, the plastic sheath, made of Nylon-6, would disintegrate, opening more pathways for bacteria to enter. Robins was aware of the problem, but, despite the risks, pressed forward with the IUD's release.
Concerns were raised almost immediately. Women returned to their doctors complaining of bleeding and pain during sex. Doctors diagnosed them with PID (pelvic inflammatory disease), which can be caused by normal bacteria, chlamydia, or gonorrhea. Antibiotics took care of most of these cases. Bigger problems came when it was determined that the "as advertised" failure rate of 1.1% was not accurate -- it actually had a failure rate of up to 10%. Women were getting pregnant, often resulting in spontaneous septic abortion. In the worst cases, the infection was so bad that it turned fatal, resulting in at least 18 deaths. When faced with a flood of complaints, Robins took the Dalkon Shield off the market in 1974 and began a multi-year legal defense.
Robins claimed that the devices were safe, that infections were the result of poor hygiene and unsafe sex practices. Unfortunately, tying the symptoms definitively to the Dalkon Shield was difficult to prove. The suits (400,000 or so of them) went into the 1980s, when they organized into a large class action lawsuit. By that time, even women who had not experienced symptoms found that they had scarring, often resulting in infertility. Additionally, during the removal procedure the uterus was occasionally torn due to the unique shape of the device. With financial preassures mounting, Robins declared bankruptcy in 1985. In 1988 the American Home Products Corporation purchased Robins, with the stipulation that a $2.5 billion trust fund be established to pay out settlements to those injured by the Dalkon Shield.
The 122 year old A.H. Robins Company was brought down by a product that sold for $3. Due to the length of the court cases, it was ultimately the lawers who made the most from the process. Even then, though, hiring a lawyer was probably a wise decision. The average claimant without a lawyer received only $725.00, while those with lawyers received an average of $21,000.
-Professor Walter
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