Options for contraception in America have not changed much in the past 50 years. There is the pill, the patch, the ring, and the IUD (intrauterine device). Women’s uteruses all vary in size from person to person just as much as foot size does. Widths can range from 10 to 50 mm, with an average of 27mm. This is a millimeter smaller than the narrowest IUD available in America, the Skyla. Women who use IUDs that are wider than the uterus risk pain, abnormal bleeding, and expulsion.
In the U.S., there are only five types of IUDs, all the same shape. Four release hormones (differing doses), while the ParaGard is made of copper. Other countries around the world offer various IUDs with differing size, design, and cost. They are shaped like loops, balls, or made of gold or steel. There are 22 types of IUDs in Britain; in Canada there are nine.
The limited number of IUDs in America may be based on the Dalkon Shield, a plastic, beetle-shaped device in the 1970s which caused thousands of injuries such as infection, infertility, and death. After the Dalkon Shield, the demand for IUDs virtually disappeared. As a result of the failed device, the FDA decided to regulate medical devices, yet declared IUDs with active substances to be drugs – not devices. Drug approval takes an average of 12 years to reach the market, requiring extensive research before manufacturers can begin testing.
Several of the IUDs in Europe have been on the market for 20 to 40 years and are proven safe and effective. Half a million women have used the GyneFix made in Belgium. Liberte has sold in Canada and Europe for 19 years. These companies have not tried to get approval in America because of the paperwork and cost. Regulations and product liability insurance reduce market incentive. The Liberte, nearly identical to American ParaGard, sells for $52, while ParaGard brings a price tag of up to $600.
There should be ways to shorten the approval time for products with good track records for safety in European countries. The 21st Century Cures Act of 2016 allows the FDA to consider expediting breakthrough drugs and devices, a step in reducing approval burdens.
Beaton, Caroline. “Why Does America Have Fewer Types of IUDs Than Other Countries?” Health. The Atlantic, 18 Apr 2017. Web. 20 Apr 2017.