The contraceptive implant, Essure, is currently drawing thousands of complaints from women reporting chronic pain, bleeding, and other health problems. With that, Federal health regulators plan to give a more strong warning about Essure.
According to CNBC, the Food and Drug Administration made an announcement on Monday that it would make an effort to add a boxed warning, which is considered the most serious type. This aims to give caution to doctors and patients to problems reported with the nickel-titanium implant.
However, the FDA stopped the short of removing the device from the market. This is a move preferred by a lot of women who have petitioned the agency in the last year. Instead, the agency is requiring manufacturer Bayer to conduct studies of the device to further check out its risks in different groups of women.
"More rigorous research is needed to better understand if certain women are at heightened risk of complications," stated Dr. William Maisel, chief scientist for the FDA's device center. FDA also said in a statement that Essure is an "appropriate option for the majority of women," but that "some women may be at risk for serious complications," mainly if the device shifts out of position and perforates the uterus or other organs.
The Seattle Times reported that for more than a decade, Essure has been sold out to women as the only non-surgical method for permanent birth control. Essure is made up of nickel-titanium coils placed into the fallopian tubes to spur growth of scar tissue. This would also block the sperm from fertilizing a woman's eggs. Moreover, according to Bayer, 750,000 women are estimated to have purchased the device since 2002.
But since the agency received thousands of complaints from people using the device and from doctors, FDA has added a warning to ensure the safety of these people. While Essure has already made a label that warns about pelvic pain and bleeding after the procedure, many women protested that these problems persisted and that they were so severe that they required surgery to remove the device out of their fallopian tubes, The Washington Post claimed.
The FDA also wants Bayer to conduct a study of 2,000 patients comparing the problems like unplanned pregnancy and pelvic pain between patients having installed Essure in their fallopian tubes and those receiving the traditional tubal ligation. The agency's officials also noted that they have already reviewed over 600 reports of women becoming pregnant after having Essure.
For now, the FDA officials claimed that the proposed study would take years to be done, but they said that Bayer would be expected to submit interim results by mid-2017. They also recognized that the proposed warning label will take time, but the FDA is still seeking public input for 60 days on the language for the warning and another proposed check-list for doctors.
