The Western Trust has moved to reassure women who underwent any of 209 procedures to implant a contraceptive whose manufacturer has acknowledged caused adverse effects in some women.
Last month the ‘Journal’ reported how over the financial years 2013/14 to 2017/18 209 sterilisation procedures involving Bayer’s Essure Permanent Birth Control device were carried out here.
The German big pharma firm has accepted that while the device is safe some women in Ireland and overseas have reported that the contraceptive can cause pain and other adverse effects.
The local health authority has underlined the fact that Bayer had said it discontinued the device for commercial rather than health and safety reasons.
“The Essure product was removed from clinical use due to a commercial decision by Bayer, and it was not for any product safety or quality issue,” said a spokesperson for the Western Trust.
“Bayer issued a patient information leaflet in 2017 that also emphasised that the decision to discontinue the distribution of this product was based on a commercial decision.
“They also went on to explain that patient safety and appropriate use of Essure were their greatest priorities.
“They advised any women who had an Essure device inserted who were concerned about the product, to contact their Healthcare professional in the first instance,” the spokesperson added.
On the Essure brand’s website Bayer ackowledge: “Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes; identification of inserts in the abdominal or pelvic cavity; persistent pain, and suspected allergic or hypersensitivity reactions.
“If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device,” it adds.
One local women who had an Essure device implanted over a decade ago and who asked not to be named told the ‘Journal’ she had suffered “15 years of pain”.
The Western Trust, however, have said there have been few concerns raised.
“There have been limited/minimal queries brought to our attention,” a spokesperson said.
Between 2013/14 and 2017/18 there were 209 Essure implantation procedures and one removal in the Trust area and there were no recorded complaints from local women about the devices.