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Golden Gate University Law Review

Journal

Contraceptives

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Reforms In Medical Device Regulation: An Examination Of The Silicone Gel Breast Implant Debacle, Rebecca Vveisman Sep 2010

Reforms In Medical Device Regulation: An Examination Of The Silicone Gel Breast Implant Debacle, Rebecca Vveisman

Golden Gate University Law Review

This article will consider the regulatory policies of the FDA in protecting the health of the nation's women, particularly its handling of silicone gel breast implants and its policing of the leading implant manufacturer, Dow Corning Corporation. While this article recognizes the various difficult problems which the FDA must address in protecting consumers from unsafe food, drugs, and medical devices, it also recognizes the need for reform. This article will describe what resulted from the tragedies of diethylstilbestrol (DES) and the Dalkon Shield. With these failures in mind, this article will examine present FDA policies, describe social forces outside of …


Beyond The Dalkon Shield: Proving Causation Against Iud Manufacturers For Pid Related Injury, Leslie Ellen Tick Sep 2010

Beyond The Dalkon Shield: Proving Causation Against Iud Manufacturers For Pid Related Injury, Leslie Ellen Tick

Golden Gate University Law Review

Intrauterine devices (IUDs)! have been linked to a wide variety of injuries to women, ranging from severe cramping, to spontaneous abortion, to sterility, to death. This Comment will focus on the problem of proving that scarring of the fallopian tubes, resulting in sterility or partial sterility, is causally linked to use of the IUD, and therefore, a provable element in a plaintiff's cause of action against a manufacturer for such injuries.