Buyer Beware

Abstract

As the safety and efficacy of IUDs are being appreciated by more clinicians and by more women, the demand for these devices has grown. Unfortunately, the prices of these devices have also increased over the last few years. The cost of the IUD, when amortized over the average time of utilization, is very low, but that does little to buffer women from the initial sticker shock. In times of economic hardship, effective contraception is especially important. Clearly, the women who have already invested in their devices are in a very enviable position. However, for today's patient who needs effective contraception, the upfront cost of IUDs can be overwhelming. Even insured women may find insurance coverage for IUDs to be inadequate. Each of the IUD manufacturers has special pricing for the public sector. The LNG-IUS manufacturer also donates units to the ARCH Foundation to distribute to indigent women desiring an LNG-IUS. However, clinicians may be tempted by lower priced units advertised on web sites for their private patients who do not qualify for these programs. If you type into your search engine “IUD,” an impressive array of such web sites pops up, each offering low prices. The lack of transparency of these web sites is disturbing, but their prices are alluring. We are trapped between competing ethical values of beneficence (making IUDs accessible) and patient safety. This debate is not confined to IUDs and other contraceptive devices, but in the context of these devices, there are additional elements to consider. While no one wants to be cast as an apologist for the pharmaceutical industry, the fact is that there is considerable confusion about what the term “FDA approved” really means. Many people believe that “FDA approval” involves only the original testing of the drug or the device for efficacy and safety. In this understanding, any IUD that has the same design as the product that was originally approved by the FDA should be considered FDA approved, regardless of where it was manufactured or how it was transported. Some have argued that as long as the product is the same or “comparable to” the US FDA-approved product, it should be considered FDA approved. The FDA actually is responsible for maintaining quality control long after it initially approves a product. The FDA periodically inspects manufacturing plants all over the world that manufacture products for US consumers. The Today