Ortho Evra Patch can harm

Ortho Evra Patch: How it works

The Ortho Evra Patch works to prevent pregnancy in the same way as conventional birth control pills by minimizing or preventing ovulation, thickening cervical mucus to hinder sperm from entering the uterus, and changing the endometrium to reduce the chance of implantation.
The Ortho Evra Patch is a product that delivers hormones (150 mcg of norelgestromin and 20 mcg of ethinyl estradiol, daily) into the bloodstream. The thin, smooth, one and three-quarter inch patch can be worn on the abdomen, buttocks, upper outer arm, or upper torso (front or back, excluding the breasts).

The patch contains the hormones, as well as an adhesive backing that allows exposure to water without detaching from the skin.

At the end of each of three weeks each month, the patch is replaced with a new one. The week of the user's period, the patch is not worn.
FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002.

• The FDA has logged 9,116 reports of adverse reactions to the patch in a 17 month period.
• During a 12 month period, 44 serious injuries or deaths have been associated with Ortho Evra.
• Ortho Evra was approved by the FDA in April 2002, and over 4 million women have used Ortho Evra.

There were 1,237 adverse reports for the pill over a 71 month period and 9,116 adverse reports for the Patch over an 18 month period. That means there were over seven and one-third times as many adverse reports for the Patch as for the Pill during the respective time periods.

The important and apparently dangerous difference in how it works is that rather than digestion and metabolization of the hormones, as with the Pill, the Patch causes the hormones to be released directly into the blood. Significantly higher concentrations of hormones are possible through this method of delivery, concentrations that have been linked to serious adverse health issues and even death.

Ortho Evra Patch side effects

The most common adverse events reported by 9 to 22% of women using ORTHO EVRAT in clinical trials (N= 3,330) were the following, in order of decreasing incidence: breast symptoms, headache, application site reaction, nausea, upper respiratory infection, menstrual cramps, and abdominal pain.

The most frequent adverse events leading to discontinuation in 1 to 2.4% of women using ORTHO EVRA in the trials included the following: nausea and/or vomiting, application site reaction, breast symptoms, headache, and emotional liability.

Ortho Evra Patch FDA review

FDA medical reviewers expressed concerns about Ortho Evra causing venous thromboembolisms, even before they approved the product. One stated: "Post-marketing surveillance for DVT (Deep Venous Thrombosis) and PE (Pulmonary Embolism) events will be important, as there are potential serious adverse risks (with two cases of pulmonary emboli in the clinical trials) with this new delivery system for contraception."

Little did they know that these risks would prove to be fatal for many women. Unfortunately, many women have been injured by the Patch in the five years since it was approved in November of 2001.

An Ortho Evra Patch lawyer can help

If you have been injured by the Ortho Evra Patch, please submit our free case review and we will contact you about your Texas Ortho Evra Patch injury.

 

Additionally, Jim S. Adler & Associates has offices located at City Place Building, 2711 North Haskell Ave., Suite 2100 LB40, Dallas, Texas 75204-2887; San Pedro Plaza, 7330 San Pedro Ave., Suite 700, San Antonio, Texas 78216-6237; and Bank of America, 12605 East Freeway, Suite 400, Houston, Texas 77015-5619 (serving Channelview, Texas).