Early this year, the FDA re-classified transvaginal mesh devices from a category II, which contains moderate risk with its use to category III, which is considered a high-risk device. This came after much litigation involving the implants from women who have experienced a variety of symptoms that have affected their lives.
The announcement of the reclassification came on January 4th of this year. This result came following numerous warnings of the product’s safety over the past 8 years. However, this change will only apply to transvaginal mesh marketed for the treatment of pelvic organ prolapse (POP). It does not include devices marketed for the treatment of conditions such as stress urinary incontinence or the abdominal repair of POP.
Manufacturers with mesh devices for the treatment of POP will have 30 months to submit a premedical approval application for their device to the FDA. Additionally, any companies looking to introduce a new transvaginal mesh device will have to submit the same application.
Urogynecologists support the decision made by the FDA. John O. DeLancey, MD, Professor of Gynecology and Fellowship Director of Female Pelvic Medicine and Reconstructive Surgery, University of Michigan Medical School, Ann Arbor, made a statement: “It is difficult for the FDA to keep track up with the thousands of new medical procedures developed each year over hundreds of disciplines and rapidly changing technologies.”
Douglass S. Hale, MD, FACOG, FACS, president of the American Urogynecological Society and Director of Female Pelvic Medicine and Reconstructive Surgery at IU Health and a Clinical Professor at Indiana University School of Medicine commeted on the AUGS website that the previous standards for approval of transvaginal mesh only needed successful clinical trials of a similar device. Previous approvals were based upon the use of full-length midurethral slings.
In the wake of the new regulations, the requirements for new devices are thus:
New transvaginal mesh POP devices be moved from class II to class III and have to go through the more rigorous PMA process.
Existing transvaginal mesh products must undergo Section 522 studies.
The use of transvaginal mesh in POP repair was approved by the FDA in 2002. Since then, the agency has logged thousands of complaints related to the implantation of these devices. Beginning in 2008, the agency started issuing communications relating to the safety of the devices. Consideration for the change from class II to class III began in 2014.
If you or someone you know has suffered injury due to the implantation of a transvaginal mesh device, you may be entitled to compensation. Contact the law offices of John Foy & Associates today.