FDA attempts to protect women
WASHINGTON, D.C. — In the U.S. Food and Drug Administration’s most recent announcement regarding surgical mesh, the FDA provided a historical background which delineates each step the agency took to protect women from post-surgical side effects from pelvic organ prolapse repair surgery in which surgeons used mesh to repair the damage. The FDA stated that the agency was forced to escalate their actions in response to numerous complaints of adverse events suffered by women whose surgeons chose to repair their pelvic organ prolapse with surgical mesh.
The ongoing saga of adverse events in women who had surgical mesh begins in July of 2011. At that time, the FDA published communication that addressed growing concerns about surgical mesh. The FDA guided how to prevent problems from growing. In September of that year, the FDA held a public meeting that addressed the concerns that arose in the July communication. The outcome of the meeting yielded 131 orders issued by the FDA to all 34 manufacturers of surgical mesh for transvaginal repair to follow what is known as “522 orders.” Instead of complying with the 522 orders issued by the FDA, most companies discontinued the marketing and distribution of their surgical mesh products designed for this particular procedure.
In January of 2016, the FDA reclassified surgical mesh for use in transvaginal pelvic organ prolapse repair surgery. The FDA increased the safety/risk level of the device to Level III, which is the FDA’s highest risk level. Therefore, companies had to resubmit their premarket safety applications for the device if the company wanted to continue marketing the product. The deadline for filing premarket approval applications lapsed on July 5, 2018. Any company that missed the deadline could no longer sell the medical devices. Those companies that satisfied the deadline would now face scrutiny from the FDA.
In February of 2019, the FDA held a meeting to discuss the evidence obtained through the application process and to devise safety plans to address the ongoing problems. The FDA escalated its remedial measures to their highest level on April 16, 2019, when it ordered Boston Scientific and Coloplast to remove their surgical mesh products for transvaginal prolapse repair from circulation.
