A popular form of birth control will receive a new boxed warning from the Food and Drug Administration, a new patient decision checklist and the company that makes the device has to complete a new clinical study. But local women affected by Essure say it's not enough.
The FDA announced these changes Monday regarding the approved Essure permanent birth control device. Essure is offered to women as an alternative to having your tubes tied. A doctor inserts two metal coils into a woman's Fallopian tubes causing the body to build scar tissue around the coils.
The FDA says Essure remains a good option for women as it is the only non-incisional form of permanent birth control offered to women that often doesn't require anesthesia. The agency also says many women can return to work within a day of having the procedure. The device received pre-market approval from the FDA in 2002.
But the FDA has also received more than 5,000 adverse event reports from women who say the device led to health issues.
Cecilia Bogle says after she received Essure in 2009, she learned that the device had broken into pieces inside her body.
"They located several more fragments and they weren't able to retrieve any of the fragments," said Bogle who also says she is in daily pain from the fragments and attends weekly physical therapy.
The FDA says it reviewed a significant amount of research on this device and has now ordered that the manufacturing company Bayer conduct a clinical study to examine the risks of the device.
"We continue to believe there's a reasonable assurance of safety and effectiveness and we do think the very specific follow up questions that are being required of Bayer in the post-market surveillance study will address some of those gaps that have been identified," said Dr. William Maisel during a media call Monday. Maisel is the deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health.
The FDA says it will use the results of this additional study to determine if any further actions are needed with Essure. The company has 30 days to submit a study protocol to the FDA and then by law, the study has to begin within 15 months.
The FDA says it acknowledges that some women may experience serious complications with the device including persistent pain, perforation of organs, abnormal bleeding and allergic reactions.
The FDA also says it has received 294 reports of pregnancy loss in women with the device. According to an FDA spokesman, this includes 96 ectopic pregnancies, 43 elective pregnancy terminations and 155 other pregnancy losses.
In addition to a mandatory boxed warning, the FDA is requiring a new patient decision checklist that women must sign before the procedure.
The language involved in both the boxed warning and the checklist are available for public comment for 60 days. After the public comment period closes, the FDA will implement these changes. Comments can be made online starting on March 4.
An example of the new boxed warning reads:
WARNING: Some patients implanted with the Essure System for
Permanent Birth Control have reported adverse events, including
perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic
device migration, persistent pain, and allergy or hypersensitivity reactions.
Some of these reported events resulted in device removal that required
abdominal surgery. This information should be shared with patients
considering sterilization with the Essure device during discussion of the
benefits and risks of the device.
"I do think it will deter women. I think the black box will make the doctors take a step back but I don't think it's going to really help a lot," said Bogle. "If this was happening to men's reproductive organs and these were perforating their reproductive organs and expelling out of them, this would not be black boxed right now, it would be recalled."