Although this was highly convenient, it soon became apparent that there was a serious risk of side effects with the Ortho Evra patch. Between 2002 and 2004, there were at least 30,000 reports of women who suffered adverse side effects from using Ortho Evra, including heart attack, blood clots, stroke or death.
Ortho Tri-Cyclen, the top-selling birth control pill, has six-times as many users as Ortho Evra, but it does not have nearly as many side effects. Users of the pill reported fewer than 1,300 adverse events over a six-year period, compared with more than 9,000 reports from Ortho Evra users over a period of a year and a half. At this rate, the number of patients reporting Ortho Evra side effects was nearly 28 times higher than with birth control pills.
There have been at least 23 deaths among users of the Ortho Evra birth control patch; the youngest of these was 14. What makes the Ortho Evra birth control patch so much more dangerous than the traditional birth control pill? It has to do with how a combination of progestin and estrogen are released into the body, working together to prevent ovulation and thus conception.
The Ortho Evra patch delivers the hormones through the skin, not through the stomach and liver, as it happens with the pill. This causes women to receive far more estrogen than they do with the pill.
Documents show that women using the Ortho Evra patch receive about 60% more estrogen than with the pill. Because estrogen can increase a person's risk of experiencing blood clots, Ortho Evra users are at a much great risk of this condition. Studies have shown that women who use the Ortho Evra birth control patch are three times more likely to suffer from blood clots than women who use birth control pills.
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Although Ortho-McNeil has yet to order an Ortho Evra recall, a number of women who survived the injuries they suffered while using the patch have filed Ortho Evra lawsuits against the company. These women allege that the manufacturers of the patch failed to warn women about the risk of Ortho Evra side effects and did not give them enough information about the dangers of the patch compared with the pill. Many families of women who died while using the patch have also filed Ortho Evra lawsuits.