Merck, the maker of NuvaRing, is expected to pay $100 million in nearly 4,000 legal settlements involving lawsuits brought over the NuvaRing contraceptive device.
Women’s allegations include that the NuvaRing put them at increased risks for serious blood clots and that there are insufficient warnings about risks associated with the device, according to WBUR/Boston NPR. The settlement involves some 3,800 women who brought lawsuits in federal and state courts.
Other hormonal methods of birth control, along with the NuvaRing, have been the focus of controversy over ties between the hormones used in the various methods of birth control and increased risks for blood clots, stroke, and heart attack. In fact, every hormonal contraceptive, including the birth control pill, is associated with these increased risks, noted WBUR. Guidelines just published by the American Heart Association recommend that women considering oral contraceptives, should be screened for high blood pressure because of these risks.
A clear, flexible ring that fits inside the vagina and which delivers a hormonal combination for three weeks, NuvaRing, may be associated with potentially increased risks for blood clots when compared to other hormonally-based birth control methods. “The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills,” the package safety information states, according to WBUR. During the three weeks that the device is in place, NuvaRing releases a combination of hormones that is intended to prevent ovulation and block sperm from reaching an egg. The wearer removes the ring for one week and replaces it with a new ring the following week.
Marketed for its convenience and ease of use, the NuvaRing received U.S. Food and Drug Administration (FDA) approval in 2001. Where intrauterine devices, the pill, and certain shots involve physician insertion, ongoing delivery, or daily dosing, NuvaRing is marketed as a convenient birth control option, WBUR notes. But, NuvaRing differs from some of these other hormonal birth control options because of associated increased risks for venous thrombosis—VTE. VTE is a serious blood clot that forms deep within a vein and may lead to pain and swelling, according to the U.S. Centers for Disease Control and Prevention (CDC). Should the VTE move to the lungs, a pulmonary embolism occurs. A pulmonary embolism is a serious and life-threating health issue that is marked by symptoms such as chest pain and shortness of breath, WBUR reported.
This past October, Merck added broader information to the NuvaRing warning and package label information that included that women should stop using the NuvaRing should a blood clot form, and should also stop using the device in the weeks preceding and following surgical procedures, according to WBUR. The warning noted two studies regarding the device’s risks.
A study conducted in Denmark and published in the British Medical Journal in May 2012, revealed a significantly increased risk of blood clots tied to use of the NuvaRing. Women using the NuvaRing experience a six-fold increased likelihood of developing VTE over women who did not use hormonal contraceptives. A two-fold risk of blood clots was seen when NuvaRing users were compared to women taking combined oral contraceptives with levonorgestrel, according to a prior Reuters report.
Combination hormonal birth control, including NuvaRing and also the Yaz and Yasmin birth control pills, have been named in scores of personal injury lawsuits over allegations that the hormonal contraceptives caused young women to suffer blood clots, heart attacks and strokes.