The drug companies rolled into the new millennium eager to experiment with innovative new birth control drugs and delivery methods. The early 2000s saw a spate of new implants, inserts, and injections offering the promise of more convenient, carefree contraceptives. However, widespread use would soon reveal the flaws inherent in many of these new approaches. Several products from major manufacturers were forced from the marketplace, including Implanon, Essure, and Norplant.
It looked like the vaginal ring was headed toward a similar fate in 2013, when Vanity Fair ran an article with the simple yet explosive title, “Why Is Potentially Lethal Contraceptive NuvaRing Still on the Market?”
The article not only shared the stories of young women who died or had been injured while on NuvaRing, but also revealed that Organon, the Dutch drug company that created the device, began marketing it based on a research study that included only 16 women.
Ignored Risks of the NuvaRing
The shocking article came on the heels of two major studies from different parts of the globe that raised concerns about the new device’s increased risks.
Each artificial contraceptive comes with a certain level of risk and consequence. Some complications extend across multiple forms of birth control, while others may be unique to a particular brand or delivery method. In this case, the U.S. Food and Drug Administration (FDA) rang the alarm bells about NuvaRing when they released a Safety Report that showed the device had a 56% increased risk of blood clots over the already elevated risk posed by other forms of hormonal birth control.
Another study published in the British Medical Journal examined the health records of more than a million Danish women and concluded that women using NuvaRing were 6.5 times more likely to develop blood clots than women not using birth control.
Despite the devastating numbers, Merck, the United States-based pharmaceutical company that owns Organon, was able to weather the storm. They were able to keep the product on the market. However, as more facts came to light, it became clear that they knew about the elevated risk of blood clots prior to FDA approval. In fact, the company had negotiated with the FDA to avoid including “Black Box Warnings” about blood clots on the ring’s patient information pamphlet. It was reported that Merck feared such warnings would hamper their return on investment in developing this new birth control delivery device.
The Cause of the Clots
There has been much speculation about what causes the increased number of blood clots with NuvaRing. Some theories suggest it could be that the ring is delivering a higher dose of hormones than expected. Others think it could be the way the body absorbs the hormones and the ring’s proximity to the reproductive system. Still others believe it is a continuing pattern of problems related to the newer third- and fourth-generation progestins. NuvaRing contains etonogestrel, a progestin not found in combination birth control pills.
Regardless of what’s causing the clots, there doesn’t appear to be any debate that the NuvaRing does indeed increase the risk of potentially deadly blood clots when compared to other forms of hormonal birth control (and even more so, when compared to women not using birth control).
Some women’s health advocates contend that the product is still on the market because women have weighed the risks and determined that the benefit of not having to remember to take their birth control is worth the added risk. This is based on the assumption that women are actually being told about the increased risk.
Why Take Risks with the NuvaRing?
Online forums and Facebook groups are filled with women who only found out about the risks after they were injured by the ring or it killed someone they loved. Clearly, not enough doctors are telling women about the elevated risks prior to prescribing NuvaRing. And, with important blood clot information being withheld from the patient information pamphlet, women have little hope of learning the truth about the product unless they stumble across it on an internet search. This is not the way informed consent is supposed to work.
There are plenty of other birth control options available on the market, most of which carry substantially less risk than the NuvaRing. The time has come where we need to reassess the benefit-to-risk analysis of the most dangerous birth control drugs and devices. For those whose risks outweigh the benefits, we need to remove them from the market.
Think of the lives that could have been saved if Vanity Fair’s question had been answered in 2013. Why are the most lethal contraceptives still on the market? Let’s keep the question alive. We need an answer.
Mike Gaskins is author of In the Name of the Pill.
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