Posted: March 8, 2016 Contributor: administrator
FDA Warning Issued for Birth Control Device
The permanent birth control device Essure has garnered the attention of the FDA as it has now become linked with some serious complications. In fact, recently the FDA has called on the manufacturer (Bayer) to look into the risks. The permanent birth control device is a tiny coil that is inserted into the fallopian tubes. This, in turn, creates scar tissue that works to block the sperm from reaching eggs.
While the device has been on the market for 14 years, the FDA is now speaking out about some reoccurring complaints. The most common complications are “persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”
As a result, the device will now be labeled with a “black box” warning as well as a new patient checklist. This will ensure that doctors take the time to review the necessary information prior to implanting the device. The FDA also hopes that this warning will prompt doctors to use the resources they are given to research possible complications and explain these to patients. A full consult is recommended between patient and physician.
The black box warning was prompted after more than 5,000 women filed reports with the FDA between November 2002 and May 2015. The complaints ranged from reports of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding following implantation.
Many women are feeling let down by the FDA since they believe they should have been protected sooner. In light of recent complaints, Bayer has blamed unintended pregnancies on patient error. You are likely wondering, “how can a doctor implanted device have any patient error?” but according to Bayer, these women have been lax in the recommended follow-up visits within three months of implantation to make sure that the device was working or that they have been lax about using a back-up method of birth control for those 3 months. Hopefully, with this information in mind, women can now make a more well-informed decision regarding their sexual health.