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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

NuvaRing and FDA Adverse Event Data

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Ever since a study came out in May about the increased risk that women using NuvaRing as a form of birth control face compared to women using oral contraception, the media has been abuzz. But the fact is that the problems with NuvaRing aren’t new and over the last several years, data has continuously reinforced this knowledge.

One source of data showing the risks of NuvaRing comes from the FDA. The FDA tracks “adverse event reports” related to medical products. Between April 2002 and September 2011, the FDA received 44,832 reports of reactions related to the use of NuvaRing. That included 1,827 reports of pulmonary embolism and 1,289 reports of deep vein thrombosis. Both of those are serious, life-threatening conditions that are related to one another.

Deep vein thrombosis occurs when a blood clot forms within a deep vein in the leg or pelvis. The condition can lead to a pulmonary embolism when the clot becomes dislodged from the blood vessel and travels to the lung, causing a blockage in one of the major arteries that supplies blood to the body. These types of blockages caused by blood clots can also lead to stroke, a condition where the blood supply to the brain is interrupted, causing sudden loss of brain functions. All of these conditions are brought about by the formation of blood clots, which are one of the specific risks of NuvaRing.

Lawyers are well aware of the serious health risks that NuvaRing presents compared to other forms of birth control and over the past few years, many lawsuits have been filed.. For years, there have been serious questions raised about the safety of NuvaRing, despite the manufacturer’s claims that it is “unknown” how it compares to other hormonal birth control. These risks are present in what are known as “third-generation” hormones, such as desogestrel, that began to appear in birth control medications in the 1980’s. The hope was that the side-effects of birth control would be diminished. Instead, the risks have increased and the drugs have remained on the market. With NuvaRing specifically, it has long been known that the hormones are absorbed directly into the blood. Whether that delivery method is more risky or not was simply never studied before the product went on the market.