NuvaRing Recall

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FDA recallThe NuvaRing is a contraceptive device that works primarily by preventing ovulation. NuvaRing is a flexible plastic ring that is inserted though the vagina at home, not in a medical setting. It is manufactured by Merck and Co. and was approved by the U.S. Food and Drug Administration (FDA) in 2001. NuvaRing became available by prescription in July 2002. It is estimated that NuvaRing is used by 1.5 million women worldwide.

Common NuvaRing Side Effects

Adverse NuvaRing reactions vary greatly, due to each patient’s individual hormonal responses, and can include:

  • Headache
  • Nausea
  • Weight gain
  • Foreign object sensation
  • Expulsion
  • Vaginitis, or vaginal inflammation
  • Sexual difficulty
  • Upper respiratory tract infection
  • Sinusitis, or nasal cavity inflammation due to allergy, infection, or autoimmune disease

Severe NuvaRing Side Effects

More serious side effects include stroke and heart attack. This is more likely to occur in patients that smoke, have recently had surgery, or have a history of cardiovascular disease. NuvaRing is not recommended for women who are breastfeeding. The medical device may decrease milk production, and hormones from NuvaRing could be passed to the baby through the mother’s milk.

NuvaRing Blood Clots

NuvaRing is considered a third-generation contraceptive, which means women who use NuvaRing have a greater risk of developing blood clots. This is because NuvaRing delivers a constant dose of hormones, rather than the rising-and-falling doses common in birth control pills. Blood clots can be fatal, and because of this potentially deadly side effect the public has recently been demanding a NuvaRing recall.

NuvaRing Recall

In 2011, the FDA published a large-scale study stating vaginal rings, such as NuvaRing, could increase the risk of blood clots by 56 percent. This increased risk is in comparison to women who take low-dose estrogen birth control pills. It was also reported that 40 patients died by 2011, as a result of using NuvaRing. Merck currently faces 730 lawsuits in the United States. Despite the landslide of NuvaRing lawsuits waiting to go to trial, the FDA has yet to approve a recall of NuvaRing.

NuvaRing Recall Debates in Court

A woman named Alicia Verse filed a lawsuit against NuvaRing manufacturers in Minnesota on Nov 1, 2010. Verse used NuvaRing from September 2008 through November 2008. By November 14, 2008, she suffered a pulmonary embolism. Verse’s NuvaRing lawsuit claims that Merck and its predecessors hid the fact that NuvaRing poses higher risks than those associated with oral contraceptive pills.

Verse also claims that Merck failed to provide appropriate warnings on the NuvaRing product’s labels and packaging. Her NuvaRing lawsuit states “defendants failed to provide proper and full information as to safety to the Food and Drug Administration.” Verse believes that NuvaRing should be recalled, due to her short time using the contraceptive device and her subsequent life-threatening health condition.

Multidistrict Litigation Requests NuvaRing Recall

Further litigation regarding NuvaRing demands strict product liability. Plaintiffs under NuvaRing’s multidistrict litigation (MDL) request a NuvaRing recall due to defective medical device manufacturing and design. The case also cites Merck’s failure to test the product or provide accurate warnings. In a MDL case being overseen by federal Judge Rodney Sippel, of the U.S District Court for the Eastern District of Missouri, plaintiffs claim that NuvaRing is linked to an undisclosed higher risk for blood clots. These blood clots lead to a risk of deep vein thrombosis and pulmonary embolism.

View Sources

  1. Edwards, Jim . “At Merck, an Undercover Video and 40 Deaths Plague Nuvaring Birth Control Brand.” CBS Money Watch . 19 04 2011: n. page. Web. 15 Apr. 2013. http://www.cbsnews.com/8301-505123_162-42848006/at-merck-an-undercover-video-and-40-deaths-plague-nuvaring-birth-control-brand/?tag=bnetdomain
  2. “MDL Judge Allows Expert Testimony on Alleged “Bursts” in NuvaRing’s Estrogen Delivery.” Harris Martin Publishing (2013): n.pag. Harris Martin. 07 03 2013. Web. 15 Apr 2013.
  3. Food and Drug Administration (United States) (2001). “NuvaRing NDA 21-187 Correspondence Part 1,” (PDF). p. 8. Archived from the original on 26 09 2007: n. page. Web, 15 Apr 2013
  4. “Woman Accuses NuvaRing Makers of Hiding Risks from Public.” Harris Martin Publishing (2010): n.pag. Harris Martin . 02 11 2010 Web. 15 Apr 2013. http://harrismartin.com/article/12665/
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