Sunday, 22 July, 2018

FDA restricting sales of permanent birth control over risk concerns

FDA tightens restrictions on Essure birth control device Inc. All rights reserved. This material may not be published broadcast rewritten or redistributed
Melissa Porter | 11 April, 2018, 12:33

The Food and Drug Administration is threatening Bayer with civil and criminal penalties if it doesn't better inform women about risks from one of the company's contraceptive devices. Only health-care providers and facilities that guarantee women have been told about the device's risks in advance will be allowed to implant it.

There will be new labeling for the device, which is now legally required, that restricts the sale and distribution of Essure to health care providers and facilities that provide proper information to patients about its risks and benefits.

The FDA just took an unprecedented step to limit the sale of a permanent implanted birth control device. The FDA will review and monitor Bayer's plan to ensure the company complies with the restriction. "That is simply unacceptable", FDA Commissioner Scott Gottlieb said in a statement.

"Essure.is a safe and effective medical device that benefits women by providing them with a valuable contraception option", Bayer said.

Essure, a flexible coil inserted through the vagina into the fallopian tubes that prompts obstructive tissue growth, is meant to be a minimally invasive option for permanent sterilization. Over a period of about three months, scar tissue is supposed to form around the inserts, creating a barrier that keeps sperm from reaching the eggs. Adverse events such as 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 have been reported in some women after Essure implantation.

Previously, the FDA ordered Essure's device manufacturer, Bayer, to conduct a post-market study and add a boxed warning and patient decision checklist to the labeling.

Angie Marie Firmalino, a co-founder of the group, emailed that members were "excited" to read about the FDA action. "We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process", said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA's Center for Devices and Radiological Health. The agency notes that sales of Essure have fallen 70 percent since the previous FDA restrictions were announced. The company said the decision was made for commercial reasons and had no links to safety or product quality problems. The U.S.is the only country where Essure is still being sold.

Earlier this year, Gottlieb met with critics of the device, including women who manage the Essure Problems Facebook group, which includes tens of thousands of women.

Two years later, however, many women who have gotten the device have claimed that their doctors weren't telling them about the warnings. The updated patient brochure, which includes the new "Acceptance of Risk and Informed Decision Acknowledgement", must be reviewed with the patient to ensure that she understands the information regarding Essure.

BACKGROUND: The FDA wants to ensure that each and every woman who receives Essure has been informed of the risks and benefits before getting the device implanted.