NuvaRing is a third generation contraceptive and an alternative to oral contraceptives. It was invented and first manufactured by the Dutch company Organon, but eventually the rights were sold to Merck, the current maker of the device. NuvaRing is inserted vaginally and releases hormones, much like oral contraceptives. It is designed to be more convenient and more effective because the user does not have to remember a daily pill.
As a popular newer type of birth control, NuvaRing has proven to be a big seller form Merck. On the other hand the company is facing a number of lawsuits and has had to settle for millions of dollars. The device has been shown to increase the risk of blood clot formation, which can have serious consequences, and in some cases can even be fatal.
What is NuvaRing?
NuvaRing is a small, flexible ring. It is inserted in the vagina where it releases hormones to prevent pregnancy. The ring is designed to stay in place for three weeks, removed for one week, and replaced by a new ring. It follows the same cycle as most oral contraceptives of providing three weeks of hormones and one week without, during which the user has her menstrual period.
Originally designed and manufactured by Organon, a Dutch drug and medical device company, NuvaRing is now made by Merck. It was first approved by the Food and Drug Administration (FDA) for use as a birth control in the U.S. in 2001. Merck has seen hundreds of millions of dollars of revenue every year for the ring and there have been millions of prescriptions written for it since it first came on the market.
NuvaRing is just as effective as oral contraceptives, and may be even more effective because there is no need to remember a daily pill. Women who use oral contraceptives often miss pills or take them at the wrong times. This significantly reduces the effectiveness of the medication. NuvaRing does not need to be inserted by a doctor. The user can place it and remove it each month.
How it Works
Hormonal birth control medications, whether in oral form or as the ring work by releasing hormones that mimic natural reproductive hormones. NuvaRing is a combined hormonal contraceptive, which means it contains synthetic forms of two natural hormones: estrogen and progesterone. The synthetic compounds in NuvaRing are etonogestrel and ethinyl estradiol.
This combination works to prevent pregnancy in several ways. One is that it prevents ovulation, or the release of an egg from the ovaries. This is the work of the synthetic estrogen. The synthetic progesterone, etonogestrel in NuvaRing, further prevents pregnancy by thickening the cervical mucus, which makes it more difficult for sperm to enter the uterus, and by changing the lining of the uterus to make it difficult for a fertilized egg to implant.
As a third generation birth control, NuvaRing contains lower doses of synthetic hormones than earlier contraceptives. This reduces the typical side effects of birth control, like irregular periods, headaches, and weight gain. In spite of lowered amounts, the third generation contraceptives are just as effective as first and second generation pills. Also new in these third generation medications are the synthetic progesterone hormones.
Most women tolerate NuvaRing well, but there are potential side effects. The most common of these include vaginal infection, mood changes including depression, headaches, weight gain, vaginal discharge, breast pain or tenderness, abdominal cramps, nausea and vomiting, acne, decreased libido, and expulsion of the ring or discomfort when the ring is in place.
In addition to these common side effects, which are not serious or life-threatening, the NuvaRing prescribing information warns about some effects that are rarer, but more serious. These include raised blood pressure, migraines, liver disease, toxic shock syndrome, a type of infection, and excessive uterine bleeding. The ring is not indicated for use in women with breast cancer or at risk for breast cancer, with liver disease or cancer, with abnormal uterine bleeding, or with an allergy to any of the materials in the ring.
Deep Vein Thrombosis
In addition to these risks there is a serious and life-threatening risk of deep vein thrombosis when using NuvaRing. Deep vein thrombosis, or DVT, is the formation of a blood clot, usually in the legs. This can be dangerous because if the clot migrates to the lungs it can become a life threatening pulmonary embolism. It can also move to the brain or heart and cause a blockage that leads to a stroke or heart attack. DVTs can be fatal if not treated.
Several studies, as well as reports of adverse events, have found that third generation contraceptives, including NuvaRing, increase the risk of a woman developing a DVT. One of the most important contraindications for NuvaRing is that it should not be used by someone who has other risk factors for DVT. These may include having a history or family history of DVT, being obese, or having a family history of heart disease and high blood pressure.
The first indication that NuvaRing could cause DVTs came from the early clinical trials for the device. It has long been known that hormonal contraceptives can increase the risk of blood clot formation, but what was different with NuvaRing was that the clinical trials showed that a healthy, young woman, with no other risk factors could develop DVT. Since NuvaRing has been on the market, there have been numerous reports of women dying from blood clot complications.
Activist groups have tried to get third generation contraceptives like NuvaRing banned through petitions and sharing information about the risks of the drugs, but with no success. In the face of the evidence, the FDA has issued warnings, but has made no move to ban these drugs and devices. The agency has required that NuvaRing carry a black box warning that indicates women over 35 who smoke should not use the device. They are at an especially high risk for developing DVT while using NuvaRing. The black box also warns that smoking at any age while using NuvaRing increases the risk of cardiovascular events.
Many women who have developed clots while using NuvaRing, as well as the loved ones of those women who died as a result, believe that Merck has not adequately warned the public about the risks. They claim that Merck has been advertising and selling a device that is known to be dangerous and to cause fatalities among users and that the risk of blood clots is two times as great as with other contraceptives.
Lawsuits against the company have so far resulted in a $100 million settlement. The settlement resulted in an average payout of $58,000 per plaintiff, a trivial amount for those who lost a loved one to this medical device. If you have been affected by NuvaRing, you have time to make your case. Speak with a lawyer for advice and to find out what your options are.