FDA used faulty data to approve Essure contraceptive coil: study
June 6, 2016 (LifeSiteNews) – The U.S. Food and Drug Administration has used faulty data to approve many high-risk ob-gyn medical devices in the last 15 years, a new study says, including the controversial contraceptive device Essure.
“Recent controversies surrounding obstetrics and gynecology devices” including among other things, the Essure contraceptive coil device, “highlight the need for deeper understanding of obstetrics and gynecology medical device regulation,” the study’s authors, based at Northwestern University, said. “Our results reveal significant weaknesses in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices.”
The authors identified Essure, classified as a “permanent contraceptive device” intended to last a lifetime, as among 18 devices posing the greatest risk to patients that were green-lighted by the FDA between 2000 and 2015. Essure was approved based on short-term evidence and insufficient post-market follow-up, according to the researchers.
“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices,” Doctor Steve Xu said. “Requirements are decided on a case-by-case basis.”
Xu further questioned the fact that medical devices have lower approval criteria than drugs.
“There are much higher standards for the approval of new drugs, whether oral, injectable or even topical,” he continued. “The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”
The FDA gave approval in 2002 for Essure, a metal coil inserted into a woman’s fallopian tubes intended to irritate the tubes, creating scar tissue to block her eggs from being released into her womb for fertilization.
Serious, long-term health dangers associated with Essure include ectopic pregnancy, unintended pregnancy resulting in severe complications and miscarriage, pelvic complications, pain, migration of the metal inserts through the fallopian tubes into the abdomen, puncture of the uterus, perforation of the fallopian tubes, hemorrhage, organ damage, fatigue, depression, weight gain, menstrual irregularities, headaches, rashes, itching, severe pelvic pain, and death.
The Northwestern University study’s authors say that their results, published in the June 2016 journal Obstetrics and Gynecology, show that the FDA approvals should be based upon more rigorous clinical studies than required now, both before and after the devices make it onto the market.
“Devices are a huge part of the medical care that we provide women on a daily basis,” the study’s lead author Doctor Jessica Walter said. “We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use.”
In addition to contraception, the devices in the study, titled, Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems, were approved for things such as reducing menstrual flow and fetal monitoring.
Of the 18 ob-gyn devices reviewed for the study, six of them, or 33 percent, were not required to go through post-market studies to examine ongoing safety.
Four of the devices, or 22 percent, were approved despite failing to demonstrate effectiveness in clinical trials.
Three devices were ultimately withdrawn from the market after approval. Of those three, two had not been reviewed by the FDA’s obstetrics and gynecology advisory committee’s physician experts, and the one that was reviewed by the committee did not get its recommendation for approval.
Authors of the study also expressed concern over the “21st Century Cures Act,” legislation passed last year in the U.S. House of Representatives containing provisions to reduce medical device regulation that is now under consideration in the Senate.
“There are provisions that would broaden the definition of the ‘valid scientific evidence’ manufacturers need in order to prove medical benefit,” Walter said. “Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”
One public health and safety advocate was not surprised by the study’s findings.
"Unfortunately, this most recent study is not unique: many studies have shown that the FDA frequently approves even the highest-risk medical devices without adequate evidence of safety and effectiveness,” said Sarah Sorscher, researcher with Public Citizen, a watchdog organization founded by consumer advocate Ralph Nader.
“A large number of these devices are never tested in randomized controlled trials, the gold standard for medical research,” Sorscher told LifeSiteNews. “And too often, serious safety concerns only come to light after the device has been marketed for years in unsuspecting patients.”
Sorscher’s group also shared the researchers’ concern regarding the likelihood the 21st Century Cures Act would weaken device regulation even further, leading to more questionable device approvals.
"Much of the activity in Congress aims at lowering the standards for these dangerous products, rather than strengthening them,” she said.
Essure’s FDA approval coming via flawed data was also not unexpected for one pro-life group.
“The fact that contraceptives are never good, and too often dangerous, for women’s health is old news,” said Human Life International’s Director of Mission Communications Stephen Phelan, “though we should be grateful when the danger is exposed in stories such as these.”
“There are now many class action lawsuits against pharmaceutical companies whose products were much more dangerous than they let on,” Phelan said, “yet these companies have made a cost-benefit decision to keep their products on the market.”
Just a couple months ago, he continued, a surprising array of pro-abortion and –contraception groups signed onto a letter criticizing the World Health Organization and the Gates Foundation for downplaying the risks of the injectable contraceptive Depo Provera.
More women, regardless of their religious values, are starting to demand answers, Phelan told LifeSiteNews.
“We hope that this trend towards awareness and concern for genuine health for women continues,” he stated, “and that more women and health authorities start to question the lie that hormonal birth control, as portrayed by the Obama administration and too many other authorities, is somehow ‘essential preventive medicine.’”