Dalkon Shield

The Dalkon Shield is a "contraceptive intrauterine device" or IUD that lead to numerous injuries in women as well as a number of expensive lawsuits. This device was claimed to prevent pregnancy as well as infections. It was coined as a "technological breakthrough" and had as many as 2.8 million women using it at one time in the US. However none of these women were informed of the risks of this faulty device.
The most important thing the inventors and investors at the Dalkon Corporation failed to do was to test their product sufficiently. Only one insignificant study was put out but later was found to be false because of the investigator's conflict of interest. It was later proven that he had invested in the company and was given a percentage of the profits. This investigator failed to report to the users that the device could carry bacteria to the sterile environment of the uterus. The longer the device stayed in the body, the more bacteria was introduced. Another problem involved the tailstring of the device that underwent hydrolysis in the body. This lead to the disintegration of the outer shealth and even more passage ways for bacteria to enter. And finally, another part of the design became embedded in a layer of the uterus speeding up the process of infectious diseases since this tissue is extremely susceptible to infections. Because of the faulty design, bacteria caused thousands of women numerous infections and diseases ranging from pelvic inflammatory disease (PID) to infertility.
Over 300,000 lawsuits were filed against the Dalkon Corporation and eventually lead to FDA's requirement of testing medical devices through the Medical Device Amendments.



http://en.wikipedia.org/wiki/Dalkon_Shield