On Monday, the Food and Drug Administration declared that pelvic mesh, when used to repair organ prolapse in women after childbirth, will now be considered a class III, or high-risk, medical device.
According to CBS News, manufacturers of pelvic mesh surgical implants will now be required to undergo more intense safety demonstrations in order to ensure the effectiveness and safety of their products.
Thousands of injuries have been reported with respect to pelvic mesh devices, which are typically implanted in women after childbirth when the woman suffers from pelvic organ prolapse, or POP.
POP occurs when one or many reproductive organs fall out of place, which can potentially lead to pain, constipation or urinary issues.
Mesh surgical implants are not limited to those of the pelvic variety, which is all the FDA is concerned with at this juncture. Mesh implants for the treatment of other conditions such as hernias or urinary incontinence will not be subject to the same amount of scrutiny as pelvic implants.
The Washington Post recently indicated that as many as half of women might experience pelvic organ prolapse, or any similar condition which would require a mesh treatment. As many as 200,000 women undergo pelvic mesh related operations each year.
Mesh products were introduced for pelvic repair in the 1990s and were marketed as a way of speeding up a patients’ recovery time. In 2011, the FDA claimed that about one in ten women experiences complications from the mesh, sometimes so intense that multiple surgeries were required to remove it.
Mesh manufacturers, like Johnson & Johnson, Boston Scientific, and Endo International, have been hit over the years by tens of thousands of lawsuits concerning mesh related difficulties.
Alternative, non-surgical options to pelvic mesh include pelvic floor exercises known as Kegels. Additionally, there exist non-invasive devices designed for treatment, such as the PeriCoach, which allows users smart-phone guided pelvic floor muscle training  for the treatment of incontinence.