Celiac disease experts assert that genetic predisposition, exposure to gluten and a triggering event create the ‘perfect storm’ that leads to the development of the disease.
5000 “adverse-event reports” submitted to an FDA data base about Essure’s non-surgical, permanent sterilization solution. In many cases, women resorted to surgical procedures to remove the devices.
Kiley Crossland of nickel-based coils, inserted into fallopian tubes, have been implicated in chronic pain, perforation of fallopian tubes, bleeding, pregnancies and possible device-related deaths.
Approved for use by the FDA in 2002, the device was said to form scar tissue in the tubes, permanently blocking sperm from reaching released eggs. Proponents argue the device is the only nonsurgical form of permanent sterilization, does not require general anesthesia, and allowing women done with childbearing to stop taking hormone-based contraception. Dissatisfied Essure patients at last week’s meeting called for an FDA recall.
A public meeting, held Thursday at FDA headquarters, included a panel of obstetrics and gynecology experts, FDA staff, representatives from Bayer HealthCare, the device manufacturer, as well as Essure patients and family members who shared about their problems with the device.
Critics argue the FDA fast-tracked the approval process to get the device on the market and say incomplete studies have not provided enough information on possible allergies and risks.
“How can we not have data on nickel allergy when you have a device that is 55 percent nickel and 20 percent of women are known to be nickel allergic?” asked Dr. Peter Shalock of Harvard Medical School, one of the experts on the panel. “Why is there no data on that in your package?”
An op-ed published in the New England Journal of Medicine last week called into question the two scientific studies completed before FDA approval, purporting to show the device was safe. “Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the premarketing-approval evaluation indicated,” according to the authors, three doctors from the Yale School of Medicine.
They argue the studies only included women with successful implants, and tracked only 85 percent of patients for a year, and only 25 percent for two years. The authors call for a new study looking at specific risks and tracking patients for five years.
“When the FDA approved Essure, they moved too quickly on a relatively incomplete set of data,” Sanket Dhruva, one of the op-ed authors, told CNN.
But some testimony supported Essure’s continued use. Dr. Raegan McDonald-Mosely, the chief medical officer for Planned Parenthood, said her organization conducted an internal review and found few problems with Essure, according to The Times.
“We continue to offer Essure as an important option,” she told the panel. The Associated Press contributed to this report.