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FDA to Review Essure Birth Control Device

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The FDA recently scheduled a public meeting to review scientific data on the Essure birth control implant. The meeting will take place on September 24th 2015 with the Obstetrics and Gynecology Devices advisory panel. This is in response to over 5,000 complaints that the implant is causing major health problems.

The Essure Permanent Birth Control method is made up of two (flexible) metal coils; the coils are inserted into the fallopian tubes by a catheter that is passed through the cervix and uterus. Three months after insertion scar tissues begins forming around the coils which causes a blockage. This blockage should not allow sperm to reach the egg thus preventing conception. The implant has been on the market since 2002 and has been implanted in about 750,000 women. Bayer (the manufacturer of the device) markets the implant as a non-surgical alternative to tubal ligation, which does not require drugs. So far over 18,000 women have shared their complaints/symptoms on a Facebook page called “Essure Problems”.

Some serious medical complaints by patients who have had the Essure Permanent Birth Control implanted include; perforation of the uterus and other organs, fragmentation of the coils, autoimmune symptoms, unexpected pregnancies then miscarriages, unmanageable pain and even death. Thousands of women are teaming up in an effort to pull Essure off the market. In addition to the public meeting in September the FDA has taken action by updating their Essure Benefits and Risks website to include both short and long term risks associated the birth control implant. The FDA recently approved a request from Bayer to update the patient information booklet for the implant. The booklet will now include an Essure warning that the device carries a risk for chronic pelvic pain and device migration.

The FDA has intervened on many birth control devices that were later deemed harmful. A couple of the cases include the Dalkon Shield and Yaz (Yasmine and Ocella). The Dalkon Shield was popular in the early 1970’s because the company promoted the product as highly effective and modestly priced for preventing pregnancy. However, the Dalkon Shield had a serious design flaw that enabled bacteria to travel into the uterus which led to harmful side effects like sepsis, miscarriage and death.  The FDA withdrew the implant from the market three years after its introduction and about a decade later the FDA advised all women currently using the Dalkon shield to have it removed.  This was also followed with thousands of lawsuits.

Yaz is a popular birth control pill made by Bayer, the pill contains synthetic estrogen and progesterone. The two hormones help to prevent ovulation and increase vaginal fluids which prevent sperm from reaching an egg. In 2006, Yaz became the best selling birth control pill. The advertising for Yaz portrayed the pill as the new generation for birth control and could help the women using it lose weight and reduce acne. The synthetic progesterone (also called drospirenone) used in Yaz (and other birth control pill such as Yasmin and Ocella) have been linked to several serious side effects that include increased blood clots, increase potassium levels, pulmonary embolism and heart attacks. In October 2008, the FDA  sent a Yaz warning letter to Bayer about overstating the efficacy of Yaz and minimizing the serious risks associated with the drug. Bayer eventually paid over $1.7 billion to settle thousands of Yaz cases.

Stay tuned.

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  1. up arrow

    […] FDA to Review Essure Birth Control Device – However, the Dalkon Shield had a serious design flaw that enabled bacteria to travel into the uterus which led to harmful side effects like sepsis … women using it lose weight and reduce acne. The synthetic … […]

  2. up arrow

    […] FDA to Review Essure Birth Control Device | Richmond Legal Examiner | Richmond … Some serious medical complaints by patients who have had the Essure Permanent Birth Control implanted include; perforation of the uterus and other organs, fragmentation of the coils, autoimmune symptoms, unexpected pregnancies then miscarriages … Read more on Legal Examiner […]

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    […] FDA to Review Essure Birth Control Device – The Essure Permanent Birth Control method is made … Yaz became the best selling birth control pill. The advertising for Yaz portrayed the pill as the new generation for birth control and could help the women using it … […]

  6. up arrow

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  7. up arrow

    […] FDA to Review Essure Birth Control Device – The Essure Permanent Birth Control … using it lose weight and reduce acne. The synthetic progesterone (also called drospirenone) used in Yaz (and other birth control pill such as Yasmin and Ocella) have been linked … […]

  8. up arrow

    […] FDA to Review Essure Birth Control Device – The advertising for Yaz portrayed the pill as the new generation for birth control and could help the women using it lose weight and reduce acne. The synthetic progesterone (also called drospirenone) used in Yaz (and … […]

  9. up arrow

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  10. Dyson says:
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    Federal regulators said they will hold a public meeting to “discuss scientific data regarding Essure’s safety and effectiveness,” a review that comes after the I-Team uncovered inconsistencies in a clinical trial survey used to win FDA approval for the birth control device. Essure is intended to be a permanent way to block pregnancy.