A Yale study has reported that pregnancy was four times more likely in women treated with the Essure birth control system than more traditional laparoscopic tubal ligation.
The U.S. Food and Drug Administration (FDA) approved the Essure birth control system in 2002. Bayer now markets Essure, which was originally developed by Conceptus. Bayer disputes allegations that the product is unsafe.
Meanwhile, several women have died from complications associated with the device; non-fatal adverse events include metal toxicity, headaches, fatigue, and lifelong autoimmune problems.
According to a report from NBC News, several women involved in a clinical trial in 2000, indicated that their records were altered. One woman, after obtaining records related to the device in 2013, said her records were obviously altered. She was also quoted as saying that, when she reported pain, the information was crossed out in the records. Another woman reported that when she cited “sharp pain,” the researchers reported her comfort level as “excellent.” In other cases, patients reported being coached by researchers on how to describe their adverse reactions. There were also reports of women between the ages of 20 and 30 who were implanted with the Essure system who had to undergo total hysterectomies.
The FDA has cited Conceptus for multiple problems in 483 documents, including failure to disclose adverse events. There were a minimum of 41 reports of perforation, mostly of the uterus and fallopian tubes. The dates related to the tests were from July 12, 2012 to December 10, 201. There were 508 incidents of perforation as of January 6, 2010.
The FDA reported that an announcement concerning Essure will be made by the end of February.
from Parker Waichman http://www.yourlawyer.com/blog/false-data-allegedly-reported-concerning-essure-birth-control-system/
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