“When the FDA approved Essure, they moved too quickly on a relatively incomplete set of data. We don’t really know how well it works.” ~ Sanket Dhruva, Yale researcher.
Holy Hormones Journal: Well, if that is not a medical experiment, I do not know what is. Essure just like so many other products (namely Gardasil, the HPV vaccine), was fast tracked through the FDA. Bayer, the manufacturer, said the “high success rate” was based on a study of 449 women. According to Bayer, none of the women in the study became pregnant during five years of follow-up.But there is not mention of other side effects -so again the question is at what cost?
One woman, Kristiana Burrell became pregnant while she had the Essure implant, delivered a still birth because the coil could not be removed without harm to the fetus. However, the device’s coil ruptured her amniotic sac causing her to deliver prematurely. In addition, Burrell had to have a hysterectomy because the device perforated her uterus.
Oh, did I mention that the study was funded by Bayer?
It was interesting to read on the BBC news site that women in the UL do not have to be concerned about the safety and efficacy of the Essure birth control implant – even though in September a hearing was held before the FDA.
According to CNN, “From November 2002 through May 2015, more than 5,000 women complained to the Food and Drug Administration about the sterilization device, saying it caused problems including unintended pregnancies, stillbirths and debilitating pain and bleeding.”
The implant was approved by the FDA in 2002. The small metal spring is designed to be placed in the Fallopian tubes, so that no egg can pass through. Essure implants are small, metal coils a doctor inserts in a woman’s Fallopian tubes, and within three months, enough scar tissue forms to block the tubes and prevent pregnancy. A woman must use another form of birth control in the meantime. So doctors are blaming the problems with Essure on women (go figure). Many of them do not return to the clinic for their three month check up. However, it appears the problems with the device begin after this period of time.
One woman reported that she had the implant inserted in 2009, but by 2011, she would get sharp pains in her sides that shot down her legs. “My legs would go numb, and when I`d get a pain in my legs, I`d just drop to the floor.”
“Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement,” the FDA said in a recent statement. “We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.”
In a statement on its website, Bayer said “that the device is 99% effective at permanently preventing pregnancy. Unlike tubal ligations, the procedure is done through the vagina, so there are no incisions in the abdomen.”
“The safety and efficacy of Essure is supported by more than a decade of science,” Bayer said in a statement. “We sympathize greatly with any woman who has experienced problems with Essure.”
At end of September, the FDA held an all-day hearing on Essure, taking testimony from patients and experts, and promising to announce next steps in the near future.
Somehow I am not feeling reassured – are you?
Women reassured over safety of Essure birth control implant
UK regulators are reassuring women the permanent birth control implant Essure is safe despite concerns in the US.
The MHRA says it will continue to monitor all side-effects and advises UK women who experience problems to see a doctor.
But some users say they have been injured by it.
Although rare, there have been instances of the device puncturing neighbouring organs, such as the bowel.
Other women have reported nasty side-effects, such as allergy to nickel found inside the implant.
US regulator the Food and Drug Administration has been holding meetings to evaluate the benefits and risks.
It says it has received more than 5,000 reports about Essure in the past 13 years.
The UK’s MHRA says it cannot provide any such data to the BBC, although it does collect it.
But it insists the device – given to about 1,500 women a year in the UK – is safe.
A spokeswoman said: “We currently have no information to suggest that Essure devices used in the UK are unsafe to use.
“We liaise regularly with the US FDA and are aware of the recent open meeting of their obstetrics and gynaecology devices panel discussing post-market experience with the Bayer Essure female sterilisation device.
“We continue to monitor all adverse incidents reported to us.”
Essure Simple Birth Control – Millennium Gynecology