Citing the continued inconsistency in adequately informing women of the risks associated with Bayer's ( +0.4%) permanent contraceptive device, the FDA has restricting the sale and distribution of the product only to those healthcare providers and facilities that provide information to patients about the risks and benefits of the device, specifically, a patient brochure that contains a checklist to guide the discussion to ensure that all relevant topics are covered.
"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 chose to "impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness". However, numerous reports of adverse events, including procedural complications, need for second procedures, chronic pain, and device failure - i.e., patients became pregnant - prompted the agency to begin re-examining Essure in 2015.
Bayer must implement the latest restrictions immediately and ensure that health care providers comply with them, the FDA said. It said the FDA "has repeatedly determined - after a rigorous review of the scientific evidence" that Essure "is a safe and effective medical device that benefits women by providing them with a valuable contraception option". Essure Problems, a Facebook-based advocacy group that claims more than 37,000 members, has lobbied the FDA to take the device off the market. That is simply unacceptable. In a procedure that takes about 10 minutes, doctors insert two sets of tiny coils through the vagina and cervix and into a woman's fallopian tubes, which carry eggs from the ovaries to the uterus.
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Almost 18 months ago, the FDA required Bayer to add a boxed warning to the product labeling stating information about adverse events linked to the device, "including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions". 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. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression.
Further action may await completion of a postmarketing study the FDA ordered Bayer to conduct in 2016. The agency notes that sales of Essure have fallen 70 percent since the previous FDA restrictions were announced.
Last year, almost 12,000 "adverse event reports" were submitted, including stories of device removals that required hysterectomies, said Madris Tomes, founder and CEO of Device Events, which seeks to bolster patient safety by sharing information about negative reactions to medical devices. USA health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women. Some experts expect the company to stop selling Essure in this country, as well. The agency noted that most of the new reports came from attorneys representing patients suing Bayer.