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Essure side effects 34 articles

Boxed warning, patient checklist to come with Essure permanent birth control

The controversial permanent birth control device Essure will now come with an updated safety label that includes a boxed warning about potential injuries and a patient decision checklist to ensure that women who are considering being implanted with the device are aware of the potential risks associated with it. Essure, manufactured by Bayer, was approved by the Food and Drug Administration (FDA) in 2002. It consists of two nickel alloy coils that are inserted into each of the fallopian tubes. Scar tissue builds up around the coils forming a permanent barrier preventing sperm from reaching the egg. In recent years, ... Read More

FDA adds warnings to permanent female sterilization implants

Just months after the Food and Drug Administration (FDA) recommended a boxed warning be placed on the permanent birth control device Essure over injuries and unintended pregnancies, the agency recommended boxed warnings be added to all female sterilization implants to address concerns that women are not receiving or understanding information about the risks and benefits of these implants. The devices are called hysteroscopically placed tubal implants and they are designed to be a less invasive alternative to tubal ligation, which involves surgically cutting or closing the fallopian tubes to permanently prevent pregnancy. Essure, made by Bayer Healthcare Pharmaceuticals, was approved ... Read More

FDA approves Bayer’s study plan for tracking Essure side effects

The Food and Drug Administration (FDA) has given the go-ahead to Bayer’s updated post-market surveillance study plan for its non-surgical permanent birth control device Essure. The controversial contraceptive has been linked to tens of thousands of adverse events including allergic reactions, autoimmune reactions, unintended pregnancies, miscarriages and fetal deaths, and four cases of adult death. The device can also migrate from its intended position in the fallopian tubes and damage neighboring tissue and organs. Essure, made by Bayer and approved for marketing in the U.S. in 2002, consists of two nickel alloy coils that are inserted into the fallopian tubes ... Read More

California judge allows Essure lawsuits to advance

A California judge has found that under state law, lawsuits filed by 14 women in 11 consolidated cases involving allegations that Bayer had failed to warn the Food and Drug Administration (FDA) about tens of thousands of complaints associated with its permanent birth control device Essure from 2008 to 2013, are not preempted by federal law and can advance. Bayer had argued that it was protected from personal injury lawsuits because the device had been approved by the FDA. Superior Court Judge Winifred Y. Smith disagreed. However, she did side with Bayer in one area, saying that claims made by ... Read More

Bayer ordered to collect data on Essure side effects

The Food and Drug Administration (FDA) is ordering Bayer to conduct a study aimed at providing insight into the “real world” risks associated with its controversial permanent birth control device Essure. Essure was approved in 2002 and remains the only non-surgical birth control method on the market. It consists of two nickel alloy coils that are inserted into the fallopian tubes. Over the course of about three months, scar tissue builds up around the coils and creates a barrier that prevents pregnancy by blocking the sperm’s path to the egg. Essure has been linked to tens of thousands of complications ... Read More

Essure birth control is convenient but controversial

Essure birth control is the most controversial method of permanent sterilization but it became a standard of care in recent years, particularly for Planned Parenthood, which found that the device could be placed in patients in a non-surgical setting, according to The Center for Innovative GYN Care. Essure, manufactured by Bayer, is made of polyethylene terephthalate fibers that are encased in nickel-titanium and formed into coils. The coils are placed in each of the fallopian tubes during a hysteroscopic procedure. In about three months, the body builds up scar tissue around the coils, which form a barrier that prevents the ... Read More

Woman has hysterectomy two weeks after Essure procedure

Erin Kearns says if she knew the suffering she would endure after being implanted with the permanent birth control device Essure, she would have made other choices in contraception. She says she suffered so much abdominal pain and bleeding following the procedure that two weeks later her doctor performed a hysterectomy. She was just 28. “I wish I had known more about (Essure procedure) before I had it done,” she told Fox6 Now. Kearns wanted a permanent form of birth control. Her doctor told her about Essure. Unlike tubal ligation, Essure would not involve surgery so recovery would be much ... Read More

Proposed bill will clear the way for women who claim they were harmed by Essure birth control to sue Bayer

Kristina Burrell had three children and three stepchildren. She felt her family was more than complete. When discussing birth control options with her gynecologist, she was thrilled to hear about Essure, the only non-surgical permanent birth control method available in the U.S. The procedure didn’t require any incisions or operating rooms, and recovery would be much shorter than if she had opted for tubal ligation, a surgical sterilization method. Essure, made by Bayer, consists of two nickel alloy coils that are inserted into the fallopian tubes. Over the course of about three months, the coils build up scar tissue and ... Read More

Women fight to sue Bayer over Essure side effects

Bayer thought it was protected from personal injury lawsuits involving its permanent contraceptive device Essure, but women who allege they were injured by the birth control method are demanding their day in court. Essure was approved by the Food and Drug Administration (FDA) in 2002 and remains the only non-surgical permanent birth control device on the market. It consists of two nickel alloy coils that are inserted into the fallopian tubes. Over a few weeks, the body builds up scar tissue around the coils, which form a natural barrier preventing the sperm from fertilizing the egg. Essure is intended to ... Read More

Permanent birth control Essure causing some women permanent pain

After the birth of her second child, Felicia Crossland knew she was finished having children. She opted for the only non-surgical permanent birth control method on the market – Essure. What she didn’t expect is to be left with permanent pain. Essure seemed like a perfect solution. The Texas woman didn’t like the idea of being put under with anesthesia and the recovery time with traditional tubal ligation. Her doctor told her that the contraceptive Essure would not only be permanent, but would offer much shorter recovery. Essure, made by Bayer Healthcare, consists of two nickel alloy coils that are implanted in ... Read More