FDA Cautions Bayer Over Postmarket Requirements for Essure
Bayer announced it would stop selling its Essure permanent birth control device after Dec. 31 and the FDA said it expects the company to meet its postmarket obligations.
“For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA,” said FDA Commissioner Scott Gottlieb said.
The device is estimated to have been used by more than 750,000 patients worldwide and it has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.
When adverse events first surfaced in 2015, the FDA convened an expert panel to investigate complaints. In February 2016, the agency ordered Bayer to conduct a post-market study to better evaluate the device’s safety profile, and in November 2016, the agency updated the labeling of the device, adding a boxed warning and a patient decision checklist to help women considering Essure be fully informed about potential risks.
In April, when the FDA became aware that many patients were not being adequately counseled, it limited sale and distribution of the device to health care providers and facilities that provide information to patients about the risks and benefits of the device to give patients the opportunity to sign an acknowledgement that they fully understood the potential risks before having the device implanted (IDDM, April 16).
“This method of permanent birth control, where coils are inserted into the fallopian tubes creating a blockage that prevents the passage of an egg from the ovary, has been associated with numerous adverse events that were reported to the FDA including a significant collection of recent reports that have mentioned issues involving surgery to remove the device,” Gottlieb noted.
UK Limits Use of Vaginal Surgical Mesh
The UK’s Medicines and Healthcare products Regulatory Agency is “pausing” the use of vaginal surgical mesh for stress urinary incontinence and pelvic organ prolapse. MHRA said the procedure has not been banned, but it will be implemented through a “high vigilance program of restricted practice.”
Surgical mesh is used to provide temporary or permanent support for weakened structures and muscles in surgery. Other common uses include the repair of hernias, pelvic organ prolapse and stress urinary incontinence.
NHS England said that vaginally inserted meshes will only be used when there is no alternative “and after close and comprehensive consultation between patient and clinician, with rigorous oversight and governance at all times.”