The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. “While conducting a post-market study and issuing labeling recommendations are positive developments, these actions mean nothing unless the FDA is able to take action…”
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Essure is a permanent and nonsurgical form of birth control for women. Over a period of about three months, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
But the FDA stopped short of removing the device from the market, a step favored by many women who have petitioned the agency in the previous year.
Essure is a metal-and-polyester coiled device that includes nitinol, a combination of nickel and titanium that is widely used in other medical implants.
In a press release dated 1 March, released early Monday and then taken off FDA’s website later in the morning, the agency said it will require a new trial from Bayer that determines what kind of heightened risks there are for women.
“The FDA must approve Bayer’s plan before the study can begin”.
The company will also be required to submit interim reports on the study including data and analysis.
“A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure”. “Bayer will continue to closely work with the FDA to address their latest recommendations and to ensure the safe and effective use of Essure”.
Reaction to the FDA announcement was swift and uncomplimentary. “Do not continue to allow more women to be harmed”.
In September, the FDA called a meeting of its advisory panel to weigh the benefits and risks of Essure.
But the FDA has received thousands of reports of problems with the device from women and doctors. “My hope was that they would recommend a recall”. In 2013, an FDA review found the device to be an effective alternative to surgical sterilization options. The women who spoke detailed harms they attributed to the device, including unplanned pregnancies when it failed and surgeries to remove it after suffering painful side effects. The FDA said Monday that it put the number at 294. “So we searched for keywords in that narrative that women and their doctors would use, such as fetal death, miscarriage, still birth, stillborn and ectopic pregnancies”.
Fitzpatrick said, “I believe Congress must”.
The agency also issued a checklist for doctors to use when discussing the risks of implanted permanent birth control devices. Women are supposed to get a test after three months to make sure Essure is working appropriately, but the agency noted some women do not follow-up for the test. A checkup at that time is already recommended by the device maker, Bayer.
In September, the agency held a hearing in which some of those who filed complaints described what they went through.
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However, since the FDA approved Essure in 2002, the agency says it has received more than 10,000 complaints about Essure.
