text_1: FDA Approves Bayer's Kyleena™ (Levonorgestrel-Releasing Intrauterine System) 19.5 mg for Prevention of Pregnancy for up to Five Years
text_2: The news release focuses on a forthcoming birth control product called Kyleena. The product is implanted in the uterus and releases the hormone levonorgestrel, which the release says can prevent pregnancy for up to five years. The release does a fair job of describing the clinical trial that led to FDA’s approval of Kyleena, and also addresses potential side effects associated with the product. However, the release does not address cost at all. The release also fails to discuss similar alternatives that are already on the market, or even offer any information comparing the effectiveness of Kyleena relative to other forms of birth control. [Editor’s note: Bayer makes a number of IUD contraceptive devices including Mirena and a permanent contraceptive called Essure. This release stacks up favorably to a Bayer news release on Essure which we also reviewed (and discussed in a blog post) in terms of discussing harms, quantified benefits and quality of evidence. However, neither release addressed costs.] According to the CDC, more than 7 percent of U.S. women use long-term, reversible contraceptives — i.e., intrauterine systems or implants — to avoid unwanted pregnancy. The widespread use of these technologies means that they are both economically important and — more importantly — that such birth control systems have a significant impact on the health and well-being of millions of women. As such, it is newsworthy when new products receive FDA approval and come to market. But in order for potential users — and their healthcare providers — to make sense of a new product, they need some basic information. For example, they need to know how the new product compares to existing products on the market — and how much they will cost. This release falls short on both of those fronts.