Saturday, February 27, 2016

Essure Birth Control Maybe Linked To Diabetes, Depression, and Other Hormonal Side Effects

Essure, a product of Bayer HealthCare, is a non-surgical form of permanent birth control for women seeking sterility. The non-surgical procedure involves two flexible non-hormonal metal and polyester springs being inserted through the vagina and uterus. The springs are then inserted into both fallopian tubes. Within a few months the springs induce fibrosis and tissue cells begin to form completely covering them, inhibiting fertilization.

Essure was approved by the U.S. Food and Drug Administration in 2002. However, a series of recent lawsuits are attacking that approval with allegations that Essure may have been approved before its risks had adequately been investigated; and that Bayer failed to meet certain FDA guidelines requiring it to report annually on the women who received Essure implants as part of its clinical pre-trials.

Since its approval, more than 5,000 complaints have been filed with the FDA regarding adverse effects to the contraceptive; as well as 12 deaths reported by Bayer and 303 fetal deaths reported in the FDA's adverse event reporting database from women who conceived while using the birth control.

The litigation claims and adverse event reports of women who were implanted with the Essure include hysterectomies, bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage, ectopic pregnancy and many side effects that were not included on the products label. Many of these women allege they were never informed about these side effects.

Despite the hundreds of women reporting to the FDA's adverse event database with symptoms like brain fog, anxiety, prolonged menstrual cycle, lethargy, depression, weight gain, hair loss and even induced diabetes; the FDA does not recognize these symptoms as being in connection to Essure because, they were not observed in post-approval studies, or described in the clinical literature. This does not mean the connection doesn't exist and the hundreds of women complaining about the same symptoms are not coincidence.

Woman familiar with hormonal birth control methods may know that certain symptoms can be expected, like depression, hair loss, and weight fluctuations. Though, Essure is marketed as a non-hormonal contraceptive many women are experiencing side effects common to hormonal contraceptives. This may be due to the material the Essure is made out of. 

The Essure's coil consists of polyethylene terephthalate fibers wound around a flexible stainless steel inner coil and are surrounded by a outer nickel titanium alloy coil. Though, the stainless steel and nickel titanium metals may cause allergic reactions, we will focus on polyethylene terephthalate.

Polyethylene Terephthalate, commonly known as PETE or PET among the science and manufacturing industry is the most common plastic polymer in the polyester family and is widely used in manufacturing of clothing and containers for food and beverages.
There has been much controversy in recent years surrounding the use of PETE for food packaging and beverage containers, due to multiple studies providing evidence that common use of PETE leaches endocrine disrupting chemicals into food and beverages contained in it. One of those studies was conducted by the Montgomery Center for Research in Child and Adolescent Development in 2010. 

Endocrine disrupting chemicals are substances that induce hormonal imbalances that may cause obesity, diabetes, hormone-sensitive cancers, thyroid cancer, uterine fibroid, endometriosis, lower sex drive, androgenic hair loss and neurological illnesses like depression, attention deficit disorders, cognitive and brain development problems.

When PETE is exposed to heat for prolonged periods of time it begins to thermally decompose; other present conditions like acidity or alkalinity may increase that degradation, releasing other byproducts used in the manufacturing process. These chemicals include but, not limited to acetaldehyde, antimony, and phthalates. All of which are known to be endocrine disrupting chemicals.

If a plastic bottle of water can exceed the government regulated PETE consumption from being left in a hot car; imagine how the internal temperature of your body accompanied by your bodily fluids (which have their own pH) can trigger a thermal decomposition of the PETE fibers used in the Essure device. Over the period of months this would release a continuous cocktail of endocrine disrupting chemicals into the bloodstream.

Though, the Essure is marketed as a non-hormonal contraceptive, it's manufactured using hormonally active agents. This may explain why many women are reporting side effects that are similar to hormonal contraceptives.

The FDA has been investigating many of these claims and is set to release its update on whether Essure should be recalled at the end this month.

For tips on how to improve hormonal imbalance read my article 
8 Steps To Improve Hormonal Imbalance

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FDA Adverse Event Database #1

FDA Adverse Event Database #2

FDA Adverse Event Database #3

FDA Adverse Event Database #4

FDA Adverse Event Database #5

Montgomery Center for Research in Child and Adolescent Development, Exton, Pennsylvania, USA

The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals

FDA likely underestimated fetal deaths from Essure: analyst

Class-Action Lawsuit