Environment Overview

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are not new conditions but the available number of treatment options have increased over time. It is estimated that between 30-50% of women will experience POP within their lifetime¹ and will be faced with many options.

With women leading more active lifestyles, awareness and advancements in treatment options have increased the volume of POP and SUI surgeries. The FDA noted that in 2010 alone, approximately 300,000 women underwent surgical procedures in the United States to repair POP and approximately 260,000 underwent surgical procedures to repair SUI. Many, but not all, surgeries have included placement of graft material such as mesh. Between 2005 and 2010, the FDA received 3,979 complaints of malfunction, injury or death related to these surgeries – with the most common complaint being mesh extrusion or erosion. While the percentage of complaints compared to number of surgeries was relatively small, concern was sparked by an increased rate of complaints.

Mesh for POP can be placed in the body two ways: through a vaginal incision (transvaginal) or through an abdominal incision (transabdominal). The current concerns surrounding mesh are only centered on mesh placed transvaginally.

Mesh for SUI can be placed in the body using one or three incisions. Slings with a single incision – known as “mini” slings – are also included in the FA mesh communication.

Mesh has not been recalled. The FDA issued a safety communication in 2008 and updated it in 2011 regarding what they had found. This communication advised women to consider their options carefully and advised surgeons to weigh risks and benefits of surgery with mesh against other treatment options.

Medical device manufacturers of transvaginal mesh, animal-derived graft tissue, and single-incision slings have been required by the FDA to conduct post-market surveillance studies. The studies will determine long-term safety and efficacy outcomes of mesh surgeries compared to surgeries using only the patient’s own tissue.

As with any treatment mesh can provide many benefits but also comes with risks. Mesh is still available as a treatment option for women but patients and physicians should work together to find the best treatment path for you. As more clinical data becomes available, this too will be carefully weighed by the FDA, clinicians, and patients to help make decisions that will best restore a woman’s quality of life after POP or SUI procedure.

¹ 2011 FDA Safety Communication