More than a million women in the world carry the device. United States Health Authority analyzes the safety of the product. Women report serious adverse effects, such as hemorrhages and tumors.
conceptions that more adepts have achieved in the last decade. This tiny mechanical spring made of nickel was conquering the sympathy of users around the world for the ease with which it is implanted and its effectiveness. Now, after thirteen years in the market and more than one million users, a hail of criticism and accusations have fallen on its owner, the multinational Bayer.
While in Spain at least 240 women have reported consequences after the implantation of the contraceptive, including chronic pain, bleeding, headaches and allergic reactions, in the United States the health authority, the Food and Drug Administration (FDA) met last October 24 to a group of experts to analyze the safety of Essure. More than 17,000 American women have reported adverse effects so far. On Facebook, the Essure Problems group has 22,357 members.
“How can it be that the FDA and Bayer have no knowledge of nickel allergies?” Asked dermatologist Peter Schalock of Massachusetts General Hospital in the crowded auditorium located at the FDA’s headquarters. And he added some more incisive questions: “When did you study these people? How did you evaluate them? With what did they analyze them? ”
Essure is a method of mechanical contraception that works by blocking the fallopian tubes, the tubes that connect the uterus to the ovaries. When inserted through the vagina, without surgical incisions, it produces local inflammation that hinders the passage of sperm after sexual intercourse.
As reported by the New York Times, representatives of Bayer present in the same room defended themselves arguing that the security of Essure is supported in more than a decade of science and studies with nearly 10,000 women. They also warned that the product includes “information about nickel.” That day attendees heard reports of women with autoimmune diseases, such as lupus and celiac disease, abscesses, tumors, severe fatigue and loss of bladder control, in addition to their odyssey by the health system to achieve a diagnosis.
Complaints have skyrocketed in recent years, The Wall Street Journal reported. In U.S.A. have multiplied by 20 since 2011, reaching more than 2,200 in 2014 and 1,363 until June 2015. There are cases of women who had to undergo a hysterectomy (removal of the total or partial uterus).
In the United States, activist Erin Brokovich has taken on the defense of a large number of these women and is willing to fight against the multinational Bayer. Brokovich became famous in 1993 when he managed to put a Californian gas company on the ropes by showing he was responsible for chrome water pollution. His case came to the cinema and his character was played by Julia Roberts. Now Brokovich has discovered a new cause in women affected by Essure.
Diana Zuckerman, president of the National Center for Health Research in the United States, said during the panel of experts that some of the women who participated in Essure studies have evidence that their responses were altered by the researchers. Steven Immergut, Bayer spokesman, rejected these allegations and the company vice president said during the event that “the body of evidence on the safety and effectiveness of Essure continues to grow.”
In Spain, the newspaper El Mundo collected some testimonies from women who declare themselves affected and prepare another legal battle. “I did not want to have more children, but you can not imagine that a contraceptive will take away your uterus,” said Elena Fernández (44 years old), who was implanted in 2011 and removed two years later after infections repeated, constant abdominal swelling and continuous hemorrhages.
In Colombia, the product began to be commercialized in 2011, after receiving approval from Invima. Even some medical organizations have asked to be included in the Mandatory Health Plan.