(Story updated at 8:34 p.m. ET)
The U.S. Food and Drug Administration is recommending that pharmaceutical giant Bayer Healthcare place a black box warning on Essure, a form of birth control it manufactures that has led to thousands of adverse event reports, including some deaths.
Bayer must also conduct a new post-market surveillance observational study on the risks of the device in a real-world setting. Within the next 15 days, the company must present to the FDA a design for a study that includes more than 2,000 patients who will compare the Essure device to tubal ligation. The manufacturer must follow the patients for a minimum of three years.
Essure now must also carry a checklist for clinicians to use when talking to patients about the pros and cons of the device.
The FDA stopped short of pulling the device off the market, which was something many women had requested.
The FDA said Essure remains an "appropriate option" for the majority of women, despite the potential for serious and sometimes debilitating complications such as allergic reactions, persistent pain, abnormal bleeding, perforation of the fallopian tubes and the need for surgery to remove the device.
While there are risks associated with the device, there are also benefits, said Dr. William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health. It is the only nonsurgical, non-hormonal form of permanent birth control on the market and it does not require general anesthesia to implant, he said.
The new steps, including mandatory clinician-patient discussions and signed informed consent, will ensure that women considering Essure be fully informed of the risks, Maisel explained.
Bayer said it will continue to work closely with the FDA.
Last year, the FDA issued an alert on the product after its Manufacturer and User Facility Device Experience, or MAUDE database, found more than 5,000 reports of adverse events including unintended pregnancies, complications during removal, and fetal deaths. However, those numbers were underestimates, as Bayer later revealed it had received more than 17,000 adverse-event reports from women around the globe.
The company estimates there are about 750,000 women using Essure around the world. About 70% of them are in the U.S.
In September, a panel of independent experts told federal health officials that not enough research was done to prove the safety of the permanent female sterilization device. They said use of the device should be limited.
Some who viewed the FDA's draft guidance are already expressing concern.
“It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market," said Rep. Mike Fitzpatrick (R-Penn.) in a statement Monday. "If the FDA is going to order another study, then at minimum they should take Essure off the market during that time."
While National Center for Health Research president, Diana Zuckerman strongly supports a black box warning, she says warning language will be crucial. She was concerned by FDA statements that the device remains safe for the majority of women. “It is not scientifically defensible to make that statement, given the lack of unbiased data on Essure,” she said.
Zuckerman said perhaps Bayer is not the best entity to do a study. Their previous attempts “have not been appropriately conducted,” she said.
The American College of Obstetricians and Gynecologists, however, is worried that the recommended patient checklist may be overly restrictive and could discourage patients who are appropriate candidates. ACOG says it continues to recognize that Essure is a treatment option for women seeking sterilization who can't undergo tubal ligation.
Essure was developed by Conceptus, a Mountain View, Calif.-based device manufacturer, and approved by the FDA in 2002. Germany-based Bayer Healthcare acquired the firm that developed Essure for $1.1 billion in 2013.
The device consists of a small, soft, flexible coil made out of nickel that is inserted into each fallopian tube. Scar tissue forms around the coils, blocking the tubes and preventing eggs from becoming fertilized or getting into the uterus.
And while women used it as an alternative to surgery, an October study published in the British Medical Journal found that women implanted with the device are 10 times more likely to require post-procedure surgery than those who undergo laparoscopic tubal ligation.
During the first three months after having the Essure device inserted, women must still use an alternative birth control method. Then they must also return to the doctor's office to undergo a follow-up X-ray of the uterus and fallopian tubes to make sure the device has been placed properly and the tubes are fully blocked. At that point the method is considered 99.83% effective.
However, safety leaders pointed out gaps in which some women did not return for the follow-up appointments. The FDA said Monday that it has received 630 reports of women using Essure who became pregnant and 294 reports of pregnancy losses. Others noted that there is no specific training for doctors on how to remove the Essure device.
Safe removal of the device is one of the complications Bayer must address through the post-surveillance study, the FDA said. Others include complication rates from the device migrating, perforating other body parts or being expelled from the body.
The controversy over Essure raised broader concerns for some healthcare quality and safety leaders and patient advocates. These include how the FDA reviews medical devices; lack of transparency in clinical trials; the adequacy of post-approval surveillance for safety and effectiveness issues; the amount of attention given to patient complaints; and the marketing and financial incentives given to doctors with the goal of boosting sales of new products.
These concerns are why the FDA has been advocating for a national system that evaluates medical devices and identifies these issues more quickly than the MAUDE database. The agency first noticed the uptick of Essure complaints around 2013.
In the meantime, the agency says the new actions will improve communication to patients about the device and further study will help to better understand which women are at heightened risk of complications.
The FDA will seek comment on the draft guidance.