Rather than remove a controversial permanent contraceptive implant device from the market that has caused major health issues for thousands of women, the FDA has recommended a "black box warning" for Essure and will require the manufacturer, Bayer, to conduct a new study of 2,000 women using the device for a minimum of three years.
The black box warning—the most serious kind from the FDA—has one big problem, though. Most women never see the actual box that contains the implant before they get it, so it seems it will be up to the doctor to show the patient or notify them of the warning. And the proposed label will not immediately go on boxes, either. The FDA has a 60-day public input period on the language for the warning and a checklist for doctors to explain the device's risk to patients.
Previously, Essure's warning label only noted that the nickel in the device could lead to allergic reactions for some women.
"While there are risks associated with the use of Essure, there are also benefits," William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, told reporters Monday. "We believe informed women should have this option available to them."
Essure was approved by the FDA in 2002 in a fast-track review because it was the first nonsurgical sterilization option as an alternative to tubal ligation, and it boasted a quick recovery period. The non-hormonal, permanent contraceptive device is a flexible metal coil made of a nickel-titanium alloy and a polyester-like fiber (known as PET) that is inserted into a woman's fallopian tubes. After insertion by an ob-gyn, scar tissue forms over roughly three months to block the fallopian tubes and prevent sperm from fertilizing any eggs. Women must use an alternate method of birth control during the first few months before a follow-up visit.
However, some women report they've had unwanted pregnancies, miscarriages or ectopic pregnancies after they began using the permanent contraceptive.
Thousands of women have also complained to the FDA about other harmful effects—ranging from headaches, bloating, rashes, and hair loss to more severe issues such as memory loss, muscle weakness, depression, hallucinations, chronic pelvic pain, allergic reactions, autoimmune problems following use of the device, fallopian tube punctures, and device migration—caused by the birth control device.
Many women have ended up needing a hysterectomy to remove the device.
Essure is only the newest contraceptive device under scrutiny over reported negative effects; NuvaRing has been in the news in recent years after several women died from blood clots, and women have also reported unwanted pregnancies and other serious side effects while using an IUD.
Bayer has maintained that it will work with the FDA to put its recommendations in place, however, some lawmakers believe Essure should be removed from the market until the new study is completed. Essure had been under review by the FDA since September 2015 due to the growing number of reported complications from use of the implant.
According to Bayer, about 1 million Essure devices have been sold worldwide, with the majority having been sold in the U.S. The new study required by the FDA asks the company to monitor at least 2,000 women for problems while using the device, such as pelvic pain, unwanted pregnancies and other issues, as well as determine how the complications affect their quality of life.