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FDA to Hold Meeting on Dangers of Essure

essureThousands of complains from women who were injured by the permanent birth control device known as Essure has forced the Food and Drug Administration to schedule a public meeting to discuss the risks associated with the product.

CNA/EWTN is reporting that the device, which is considered a permanent type of birth control, consists of small metal coils which are inserted into a woman’s Fallopian tubes. As the coils implant, they create a chronic infection which causes scar tissue to form around the coils. This scar tissue closes the tubes and renders a woman sterile.

Since its approval for sale on the U.S. market in 2002, it is linked to at least seven deaths of women and five deaths of infants in women who were implanted with the device.

Typical of birth control labeling, the adverse effects are minimized on the packaging, stating that the device could cause “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body.”

In reality, more than 4,000 women have reported side such as perforated organs from the dislodging of the device, coils lodging in colons, fetal disfigurement due to nickel poisoning, chronic pain, exhaustion, bouts of depression, and suicidal thoughts.

“My hair started falling out in immense quantities… I woke up in the middle of the night covered head to toe in hives,” one woman who had the device implanted told 8News.

As a result, the FDA is now planning to hold a public meeting of the Obstetrics and Gynecology Devices Panel on September 24th to discuss “the safety and effectiveness” of Essure.

The FDA issued a statement about the upcoming meeting, saying that some women are experiencing pain and "other health problems" after receiving the implant.

“Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.”

Essure was originally manufactured by a group named Conceptus, but was acquired by Bayer in 2014.

Bayer is the same company that manufacturers Yaz and Yasmine, two new birth control pills that have caused serious adverse effects in women. More than 10,000 lawsuits are pending against the company which has paid more then $1 billion in claims.

In response to the FDA’s announcement about the Essure hearing, Bayer issued a statement in which they claimed “patient safety is Bayer’s top priority.”

They went on to say: “Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.”

The Facebook group, Essure Problems, which was set up to warn women about the dangers of this implant, is pleased with the FDA’s latest move.

“We feel like the FDA has really been listening to us, to our group, and is taking some steps in the right direction to address the serious complications and problems with this device,” said a statement by the group. “Having a large government agency paying attention to a group of women harmed by a medical device, and making arrangements to review information and allowing our voices to be heard, is huge.”

The group, which boasts of over 18,000 members, says they plan to bring as many of the original clinical trial participants to the meeting as they can.

“We need every women harmed by Essure to get to this meeting. We need every media outlet there. All are welcome. Let’s fill the room and pour into the hallways. Let your faces be seen, and let your pain serve a purpose. Not one more woman harmed by Essure.”

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