Women urge FDA to pull contraceptive device linked to pain

Bayer Pharmaceutical sent KHOU 11 News a statement calling its device “safe and effective” adding Essure is “the only FDA-approved non-surgical permanent birth control method, is supported by more than a decade of science, with more than 10,000 women studied….750,000 women have had the device implanted”.

During the Essure procedure, two metal coils are implanted inside fallopian tubes of a woman, and scar tissue is formed that blocks conception. Bayer sells the device as an alternative to traditional procedures used to “tie the tubes”.

The product’s warning labeling lists various uncomfortable side effects and dangers, together with short-term ache and bleeding after the process.

Users are also warned that the birth control implant may slip out of its position and enter the user’s pelvis or lower abdomen, following which a surgery might be needed for removing the device. Additionally, Essure is made of a nickel-titanium alloy that can cause allergic reactions – such as itching and hives – in some patients.

However, thousands of women attributed other types of problems to Essure, including some that are not on the label including fatigue, depression and weight gain.

Several women from Minnesota, all members of a Facebook page called Essure Problems, have traveled to Washington D.C.to take part in the hearing.

NewsChannel5 Investigator Sarah Buduson will have more information about today’s panel hearing at 4 p.m. on The Now and on NewsChannel5 at 5 p.m.

The FDA will ask its specialists to weigh on seemingly conflicting details about the system’s security.

The agency also reported that “over the past 2 years, FDA has seen a dramatic increase in the number of adverse events submitted in relation to the Essure device”. Last year, at age 29, she had a hysterectomy. “We sympathize greatly with any woman who has experienced problems with Essure”.

“Even if we get as far as starting new clinical trials and looking at what we’ve got going, that would be heaven for me because right there, it’ll show our problems”, said Esther. The problems include chronic pain, bleeding, headaches, and in some cases unwanted pregnancy. In a review of the device before this week’s planned meeting, the FDA said “significant limitations must be taken into account when reviewing the data”, on the device. One patient committed suicide as a result of Essure complications. Others don’t embrace a comparability group of sufferers who haven’t acquired the gadget, a crucial element of high quality medical analysis. The implant is meant to be permanent, according to the FDA.

The panel will discuss whether use of the implant should be limited, and whether Bayer should conduct more studies.