Latest Bayer Report Shows Thousands More Essure Adverse Events

When Bayer announced in July 2018 that it would stop selling the permanent birth control device Essure, the U.S. Food and Drug Administration (FDA) required the company to continue to evaluate long-term safety information in women who received the device.

According to the latest analysis from Bayer covering the period of June 1, 2020, through August 31, 2020, there were an additional 7,509 events related to the Essure reported to the FDA’s medical database, including 7,332 serious injury reports, 104 malfunction reports, and 73 death reports. The most common patient problems reported included pain, perforation, foreign body/device fragment in the patient, pregnancy, and heavier periods.

The FDA added that the limited information on the reports provided by Bayer “prevents the ability to draw any conclusions as to whether the device or its removal, caused or contributed to any of the reported deaths or other events in the reports.”

Essure Lawyers Request MDL to Centralize Lawsuits

Plaintiffs requested the U.S. District Court for the Eastern District of Pennsylvania, where Judge Gerald Austin McHugh, Jr. currently presides over three cases.

Approximately 30 lawsuits are pending in Pennsylvania, California, Connecticut, Missouri, and Idaho — with thousands more expected. Essure was implanted in over 750,000 women and the FDA has received 5,000 adverse event reports.

Lawyers want to create a Multi-District Litigation (MDL), which is like a class action. It helps coordinate discovery, trials, and settlements, while allowing each individual lawsuit to remain independent.

Essure is a permanent sterilization device made by Bayer that consists of two metal coils. It is inserted into the fallopian tubes, causing scar-tissue to grow and block sperm from fertilizing an egg.

Lawsuits accuse Bayer of failing to warn about side effects. In February, the FDA placed a “Black Box” warning label on Essure and ordered Bayer to conduct new safety studies.

FDA reviewing complaints about Essure

Jennifer is a mother of two. She lives in Glendale with her family, including two additional stepchildren. With a full house, she wanted permanent birth control.

She chose Essure. The device consists or two small metal coils which are placed inside each fallopian tube. Scar tissue grows to block conception.

But, even after doctors confirmed her fallopian tubes were fully blocked, Jennifer got pregnant.

“Essure just basically didn’t do its job. And because of that, we had to pay the price. Other women have to pay the price,” said Jennifer.

Jennifer is talking about a group of women sharing their experiences with Essure on Facebook .

Many describe the exact same symptoms like extreme bloating, skin rashes and headaches. They also post pictures, including photos of X-rays that show coils cutting through fallopian tubes and broken coils after they were removed.

There are more than 3,500 women in the group and the number keeps growing.

Patients and doctors also reported these same issues to the Food and Drug Administration. The federal government received a total of 943 adverse event reports about Essure.

Including the first reported death associated with Essure.

Now, a month after our initial investigation, the FDA responded to public pressure.

In a statement posted on their website , the agency states they “reviewed” the complaints and clinical trial documents.

They acknowledge some of the complaints are symptoms included in the Essure labeling, and some that are not.

The FDA states, at this point, its “found no evidence” of “more widespread complications” about Essure and said nothing about it’s status as a defective medical device.

Essure: Doctor files death report

Since 2004, almost 850 women and doctors have filed Adverse Event Reports with the Food and Drug Administration (FDA) about Essure birth control.

They detail extreme symptoms – from women experiencing excess bleeding, rashes and bloating to women who were forced to have their reproductive organs removed.

     *See Original Investigation

Now, the ABC15 Investigators found a new Adverse Event Report filed with the FDA just weeks ago regarding Essure. It details a woman’s death after she was admitted to the hospital for abdominal pain. She had the Essure coils implanted this year, but it has not been determined what caused her death.

‘THE LATEST AND GREATEST’

Amanda Holt saw a lot of positives when she decided to get Essure as a permanent form of birth control.

“I have three children. I work at lightning speed. And when someone told me that I can go in and get this procedure done and then go back to work that afternoon or the next morning, I’m like, ‘Absolutely! Sign me up!’” she said.

For Katie Reader, Essure sounded like a great idea. “I wanted the latest and greatest,” she said.

Essure Birth Control Device Blamed for Years of Pain

Some women who have a permanent birth control device called Essure say it has ravaged their reproductive systems, leaving them with scars, pain and years of unexplained symptoms.

The Essure system consists of a pair of metal coils designed to be implanted in a woman’s fallopian tubes. After several months, scar tissue that naturally builds up around the coils creates a permanent barrier to sperm, preventing pregnancy by a method similar to an intrauterine device, commonly called an IUD.

The problem, according to those who complain about Essure, is that the coils can cause pain, irritation, and much worse, long after they are implanted. However, there have been few complications reported to the Food and Drug Administration.

Seven women from New York, Boston and Baltimore described complications after their Essure procedures. Some cried as they recalled years of symptoms that they did not initially connect to the coils.

“One of the coils migrated. It pierced my fallopian tube, my ureter and my bowel,” said Tina Carey, who had the Essure procedure in 2008. In addition to pain associated with the punctured organs, Carey said her symptoms include hives, kidney pain, urinary tract infections and gastrointestinal problems.

Kimberly Hock, who also had the Essure procedure, decided to have a full hysterectomy two years later, to eliminate the constant discomfort. Several other Essure patients are opting for full removal of their uteruses as well.

“My body was giving out,” Hock said. “I would have migraines at least four days a week.”

Hock believes Essure is also responsible for severe mood swings she experienced while the metal coils were blocking her fallopian tubes. She says all the symptoms went away after the hysterectomy.

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