"A stroke occurs when the blood supply to part of the brain is suddenly interrupted or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding brain cells. Brain cells die when they no longer receive oxygen and nutrients from the blood or there is sudden bleeding into or around the brain.
There are two types of strokes: (1) ischemic - the blockage of a blood vessel supplying the brain; and (2) hemorrhagic - the bleeding into or around the brain. According to the NINDS:
"The symptoms of a stroke include sudden numbness or weakness, especially on one side of the body; sudden confusion or trouble speaking or understanding speech; sudden trouble seeing in one or both eyes; sudden trouble with walking, dizziness, or loss of balance or coordination; or sudden severe headache with no known cause."
A common disability from a stroke, NINDS says, is complete paralysis on one side of the body. A related disability that is not as debilitating is one-sided weakness. Strokes may also cause problems with thinking, awareness, attention, learning, judgment, and memory.
According to NINDS, stroke survivors also often have difficulty understanding or forming speech and may have problems controlling or expressing their emotions and many people experience depression.
Stroke survivors may also experience numbness, strange sensations, and pain in their hands and feet, made worse by movement and temperature changes, especially cold temperatures. And, about 25% of patients who recover from a first stroke, NINDS says, will have another within 5 years.
The serious health problems caused by the Ortho patch first caught public attention on January 9, 2004, when an article titled, "'Sex Patch' Tied To 17 Deaths," appeared in the New York Post, stating, "A trendy contraceptive patch which has been aggressively marketed using sexy ads, fashion models and Olympic athletes has been linked to the deaths of at least 17 young American women in the past two years."
Citing FDA reports, the Post said that "scores" of other women using the Ortho Evra patch have suffered complications, including 21 "life-threatening" cases of blood clots and other ailments.
Ten months later, on October 10, 2004, the New York Post published another article titled: "The Patch of 'Death,'" that stated: "A popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill," quoting a complaint filed in a Texas lawsuit by a mother of 2 who had suffered a massive stroke and was left paralyzed after using the Ortho patch for 12 days.
The lawsuit described FDA records obtained with an FOIA request, that showed that in a one-year period, at least 46 women suffered blood clot related injuries or death while using the patch and that only half that number of women taking birth control pills suffered clot related problems, even though 6 times more women used the pill.
Less than a year later, another lawsuit filed in New Jersey in September 2005, on behalf of a woman who suffered a pulmonary embolism after using the patch, disclosed that between April 2002 and September 2003, the FDA's Adverse Event Reporting System (AERS), had recorded 9,116 adverse events related to the patch, but that with the birth control bill for a period of more than 6 years, there were only 1,237 adverse reports recorded even though the pill was used by almost six times more women.
The AERS is a computerized database, designed to support the FDA's post-marketing surveillance program for all approved products, that stores and analyzes the adverse event reports that are submitted to the agency.
However, experts say, when considering the number of adverse events reports related to the Ortho patch, its important to know that according to FDA officials, only between 1% and 10% of all adverse events are reported. Which means at best, the number of adverse events reported above must be multiplied by 90%, and at worst by 99%.
Plaintiffs' attorneys maintain that J&J has long known about the serious risks of using the patch. According to a CBS New report in November 2005, citing documents obtained in a lawsuit, Johnson & Johnson's own records show the company received 500 reports of serious problems in women wearing the patch between April 2002 and December 2004. And the company records also showed that even though 3 times as many women were taking birth control pills during the same time period, only 61 similar reports were received on women taking the pill.
The records reveal that there were four times as many strokes in women using the patch, and according to the Associated Press, the medically confirmed cases indicate that the risk of blood clots was 14 times higher among women using the patch.
Many experts believe that the increase in health problems is due to the patch delivery system because the medications and dosages in the patch are the same as in the pill and prevent pregnancy by: (1) altering ovulation so that an egg is not released for fertilization; (2) thickening cervical mucus to stop sperm from entering uterus; and (3) changing the endometrium to reduce the likelihood of egg implantation.
There are two types of strokes: (1) ischemic - the blockage of a blood vessel supplying the brain; and (2) hemorrhagic - the bleeding into or around the brain. According to the NINDS:
"The symptoms of a stroke include sudden numbness or weakness, especially on one side of the body; sudden confusion or trouble speaking or understanding speech; sudden trouble seeing in one or both eyes; sudden trouble with walking, dizziness, or loss of balance or coordination; or sudden severe headache with no known cause."
A common disability from a stroke, NINDS says, is complete paralysis on one side of the body. A related disability that is not as debilitating is one-sided weakness. Strokes may also cause problems with thinking, awareness, attention, learning, judgment, and memory.
Stroke survivors may also experience numbness, strange sensations, and pain in their hands and feet, made worse by movement and temperature changes, especially cold temperatures. And, about 25% of patients who recover from a first stroke, NINDS says, will have another within 5 years.
The serious health problems caused by the Ortho patch first caught public attention on January 9, 2004, when an article titled, "'Sex Patch' Tied To 17 Deaths," appeared in the New York Post, stating, "A trendy contraceptive patch which has been aggressively marketed using sexy ads, fashion models and Olympic athletes has been linked to the deaths of at least 17 young American women in the past two years."
Citing FDA reports, the Post said that "scores" of other women using the Ortho Evra patch have suffered complications, including 21 "life-threatening" cases of blood clots and other ailments.
Ten months later, on October 10, 2004, the New York Post published another article titled: "The Patch of 'Death,'" that stated: "A popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill," quoting a complaint filed in a Texas lawsuit by a mother of 2 who had suffered a massive stroke and was left paralyzed after using the Ortho patch for 12 days.
The lawsuit described FDA records obtained with an FOIA request, that showed that in a one-year period, at least 46 women suffered blood clot related injuries or death while using the patch and that only half that number of women taking birth control pills suffered clot related problems, even though 6 times more women used the pill.
Less than a year later, another lawsuit filed in New Jersey in September 2005, on behalf of a woman who suffered a pulmonary embolism after using the patch, disclosed that between April 2002 and September 2003, the FDA's Adverse Event Reporting System (AERS), had recorded 9,116 adverse events related to the patch, but that with the birth control bill for a period of more than 6 years, there were only 1,237 adverse reports recorded even though the pill was used by almost six times more women.
The AERS is a computerized database, designed to support the FDA's post-marketing surveillance program for all approved products, that stores and analyzes the adverse event reports that are submitted to the agency.
However, experts say, when considering the number of adverse events reports related to the Ortho patch, its important to know that according to FDA officials, only between 1% and 10% of all adverse events are reported. Which means at best, the number of adverse events reported above must be multiplied by 90%, and at worst by 99%.
Plaintiffs' attorneys maintain that J&J has long known about the serious risks of using the patch. According to a CBS New report in November 2005, citing documents obtained in a lawsuit, Johnson & Johnson's own records show the company received 500 reports of serious problems in women wearing the patch between April 2002 and December 2004. And the company records also showed that even though 3 times as many women were taking birth control pills during the same time period, only 61 similar reports were received on women taking the pill.
The records reveal that there were four times as many strokes in women using the patch, and according to the Associated Press, the medically confirmed cases indicate that the risk of blood clots was 14 times higher among women using the patch.
Many experts believe that the increase in health problems is due to the patch delivery system because the medications and dosages in the patch are the same as in the pill and prevent pregnancy by: (1) altering ovulation so that an egg is not released for fertilization; (2) thickening cervical mucus to stop sperm from entering uterus; and (3) changing the endometrium to reduce the likelihood of egg implantation.
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