|Essure--Screenshot courtesy of Bayer|
It may be too little too late. But now the FDA has signed off on the use of transvaginal ultrasound (TVU) as a means of ensuring the proper placement of the Essure permanent birth control device within three months of its insertion.
This will offer an alternative to the only previous confirmation test that FDA had endorsed to examine Essure's placement: a modified hysterosalpingogram (HSG), which is an x-ray of the uterus and fallopian tubes after they have been filled with contrast dye. A physician will determine if either HSG or TVU are appropriate as a confirmation test for an individual patient, but if they are unable to do so with a TVU then an HSG will have to be performed.
"We are very pleased that the FDA has approved the TVU confirmation test for Essure. TVU provides an additional method for physicians to check that the device is properly placed and a woman can rely on Essure for birth control," said Dr. Patricia Carney, director of Women's Health at Bayer Healthcare's U.S. Medical Affairs. "TVU is approved as a safe and effective confirmation test option for appropriate patients that can be performed in a physician's office without an x-ray and does not require use of contrast dye."
The FDA is requiring physicians who offer Essure to complete a comprehensive training program on the use of TVU with Essure. The program will start in September with the physicians who perform the procedure the most often and is expected to wrap up by mid-2016. Certification on TVU will be required of physicians to offer Essure, but they can continue to use the HSG method until they are trained for TVU.
This new option for securing proper Essure placement comes as the device is under review by the FDA due to more than 5,000 complaints it has received since the agency first approved it in 2002, with the volume of complaints increasing rapidly in the last few years.
The most common reported problem is pain--particularly abdominal pain--and heavier or irregular menses. Headache, fatigue and weight fluctuations are also frequently reported. Specifically, complaints are concerned about patient/device incompatibility, migration of the device, different operation of Essure than expected, breakage and poor positioning of it.
Documents about Essure were recently posted by the FDA for a Sept. 24 Obstetrics and Gynecology Devices Panel that will review information on the safey and efficacy of the device.
Essure consists of two flexible metal fiber coils that are placed in each of the fallopian tubes through the cervix in a 10-minute procedure. Over three months, a natural barrier then forms around them. Bayer acquired the device in its 2013 Conceptus acquisition for $1.1 billion.
- here is the release
FDA panel slated to weigh Bayer Essure safety after more than 5,000 complaints
Bayer responds to article critical of its Essure birth control device under FDA investigation
Under FDA investigation, Bayer releases new data on Essure contraceptive with a positive twist
FDA to investigate Bayer's birth control device after allegations of fraud during clinical trial
FDA approves Actavis intrauterine device to prevent pregnancy
Whistle-blowing Bayer sales rep wins again in wrongful termination suit