MONDAY, April 9, 2018 (HealthDay News) — To help curb complications tied to the permanent contraceptive implant Essure, the U.S. Food and Drug Administration on Monday slapped new restrictions on the sale of the device.
The step was taken to ensure that all women considering the device “are provided with adequate risk information so that they can make informed decisions,” according to an FDA news release.
Essure is the only permanently implanted birth control device for women that does not require a surgical incision. Flexible coils are inserted through the vagina and cervix and into the fallopian tubes, which carry eggs from the ovaries to the uterus.
However, the FDA says a minority of patients have reported sometimes dangerous complications. These include perforation of the uterus and/or fallopian tubes; migration of inserts to the abdominal or pelvic cavity; persistent pain; and suspected allergic or hypersensitivity reactions.
Some women with the device have also reported headache, fatigue, weight changes, hair loss and mood changes, such as depression, but it is unknown whether these symptoms are related to Essure, the FDA said.
The agency said it became aware that some women were not being fully informed of these risks tied to Essure, “despite previous significant efforts to educate patients and doctors about the risks associated with this device.”
“We believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
So, the agency said it has decided to “impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness.”
Specifically, health care providers must review a brochure for the device with patients to ensure they understand the risks, benefits and other details about Essure implantation. The patient must be given the opportunity to sign an acknowledgment, which must be signed by the physician implanting the device.
Previously, the FDA ordered Essure maker Bayer to conduct a post-market study and to add a boxed warning and patient decision checklist to the device’s labeling. Those measures led to a 70 percent decline in sales of Essure in the United States, the FDA noted.
Bayer must implement the latest restrictions immediately and ensure that health care providers comply with them, the FDA said.
In a statement, Bayer said it “is dedicated to ensuring the continued safe, effective and appropriate use of Essure.” The company added that FDA evidence reviews have determined Essure to be “a safe and effective medical device that benefits women by providing them with a valuable contraception option.”
Still, one expert in women’s health said the FDA move can only be helpful to women.
“This is the FDA’s way of assuring that patients understand exactly what potential complications and problems can occur with Essure,” said Dr. Mitchell Kramer, who directs obstetrics and gynecology at Huntington Hospital, in Huntington, N.Y.
“As with all procedures and devices, there are pros and cons,” he said. “The most important aspect is to make sure it is appropriate for the individual patient and the provider is experienced and skilled with the procedure.”WebMD News from HealthDay
SourcesSOURCES: Mitchell Kramer, M.D., chairman, obstetrics and gynecology, Huntington Hospital, Huntington, N.Y.; April 9, 2018, news releases, U.S. Food and Drug Administration and Bayer
Copyright © 2013-2018 HealthDay. All rights reserved.
Share this Post