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Data Published on Dangers of Essure Contraceptive Device

female patient with doctorLong term data recently published about the Essure contraceptive device suggests that it may pose risks of serious complications for some women.  This data will come as no surprise to the more than 16,000 women who have filed complaints with its original manufacturer between the years 2011 and 2013.  The FDA has also received thousands of adverse event reports associated with the device, and women are urging the agency to recall the device and issue a warning about its potential dangers.

Women who have experienced complications such as pain, long-term bleeding, and organ perforation are now hiring Essure injury lawyers to represent them in court.  The personal injury attorneys of Eisbrouch Marsh are currently offering free case reviews for such women who believe that they were harmed by the Essure device.

Essure injury lawyers offer confidential case reviews

The Essure contraceptive device is essentially a coil inserted vaginally into the fallopian tubes; it functions by prompting the growth of scar tissue over a three month period, blocking sperm and therefore conception.  When it was first introduced onto the market in 2002 by Conceptus, Inc. (now a subsidiary of Bayer Pharmaceuticals), it represented the first permanent, non-surgical method of sterilization for women and a more convenient alternative to tubal ligation.

But thousands of women across the country have reported serious side effects associated with the device, including severe and/or chronic pain, heavy menstrual periods, headaches, pierced fallopian tubes and punctured surrounding organs.  Some women have had to have multiple surgeries to revolve the problems they have experienced.

Kim Hudak, for instance, experienced years of pain, extreme discomfort during menstrual periods, fatigue, migraine headaches, and joint pain, which she described as like having “a really severe case of the flu, and those were on the good days.”  Ms. Hudak often missed work because of her symptoms and has hired a lawyer to represent her in a defective medical device lawsuit against Bayer.

Filing a defective medical device lawsuit over Essure

After a petition was filed with the FDA in February, the agency turned over the investigation of the Essure device over to the Office of Compliance on March 26.  The FDA had stipulated that the agency should provide long-term monitoring of the health of women using the device, which was to end in 2007.  But it is only on April 24 of this year that the data was published in The Journal of Minimally Invasive Gynecology.  

While the FDA and Bayer believe that the risks of the device are outweighed by its benefits, not everyone is so sure.  The National Center for Health Research has begun to analyze data related to adverse event reports, while Yale School of Medicine professor Dr. Aileen Gariepy finds the omission of data on 30% of the women in the study troubling.  Most significantly, thousands of women who have suffered serious side effects believe that they were not adequately warned about the risks associated with Essure.

Attorneys from Eisbrouch Marsh have successfully litigated claims arising from defective medical devices.  We can help you to recover losses related to pain and suffering, medical expenses, lost wages, and other damages.  Please contact us at 201-342-5545 to arrange a legal consultation about your rights to compensation.