A vaginal mesh is a net-like surgical implant used to provide permanent support to weakened internal tissues. This medical device, often made from synthetic or biological materials, was introduced to address common conditions affecting the pelvic floor. Despite its widespread use, the implant became the subject of intense controversy due to a high rate of severe complications. Public and regulatory scrutiny has profoundly changed how and when this device is used in surgical practice.
The Medical Purpose of Vaginal Mesh
The primary conditions treated by the mesh are Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). SUI is characterized by the involuntary leakage of urine during physical activities, often resulting from a weakened support structure for the urethra and bladder neck. For this condition, a narrow strip of mesh is implanted as a supportive sling beneath the urethra, helping to keep it closed under abdominal pressure.
Pelvic Organ Prolapse occurs when the muscles and ligaments supporting the pelvic organs weaken, causing organs like the bladder, uterus, or rectum to descend into the vagina. The mesh is designed to reinforce the compromised vaginal wall and lift the prolapsed organs back into their proper anatomical position. Serving as a scaffold, the mesh allows the body’s own tissue to grow into its pores, creating a stronger, more durable wall of support than traditional native tissue repair.
Surgical Approaches and Mesh Types
Vaginal mesh materials are categorized based on their composition and permanence. The most common type is synthetic mesh, typically constructed from non-absorbable, macroporous polypropylene material. This synthetic fabric is intended to be a permanent implant, and its large pore size promotes tissue incorporation.
Other materials include absorbable synthetic meshes, which are designed to degrade over time, leaving behind the patient’s newly grown connective tissue. Biologic mesh, derived from animal tissue such as cow or pig skin, is also absorbable. However, the long-term effectiveness of these absorbable materials is often lower compared to the permanent synthetic versions for long-term support.
The surgical approach depends on the condition being treated, with two distinct methods prevalent for mesh placement. For SUI, the mesh is placed using a minimally invasive midurethral sling procedure through a small vaginal incision, with the ends guided through the groin or above the pubic bone. For POP repair, the mesh can be implanted either transvaginally (entirely through a vaginal incision) or transabdominally, such as in a sacrocolpopexy procedure. The transabdominal approach involves placing the mesh through an abdominal incision to suspend the top of the vagina to a structure on the sacrum.
Known Adverse Events and Complications
The widespread controversy surrounding vaginal mesh stems from a range of adverse events that often require complex medical intervention. The most frequently reported and serious complication is mesh erosion, also known as exposure or extrusion, where the synthetic material pushes through the vaginal wall or into surrounding organs. Mesh erosion rates for transvaginal POP repair have been reported to range from 5% to 15% in some studies, which is significantly higher than with other surgical methods.
Chronic pain is another major complication, often manifesting as persistent pelvic pain that can be debilitating. This pain can be localized or radiate to the groin, thigh, or abdomen, and may be caused by nerve entrapment or inflammation from the mesh. Painful sexual intercourse, or dyspareunia, is also a common complaint, especially if the mesh is exposed.
The mesh can also trigger a severe foreign body reaction, leading to chronic infection or inflammation that is difficult to treat. Over time, the mesh may contract or shrink, causing tension and a pulling sensation in the surrounding tissues, which can lead to vaginal shortening and tightening. In rare but severe cases, the mesh or surgical tools can perforate nearby organs, including the bladder, urethra, or bowel, requiring immediate surgical repair. When these complications occur, patients often require multiple, difficult revision surgeries to partially or completely remove the implanted mesh.
Regulatory History and Current Status
The regulatory landscape for vaginal mesh has undergone significant change in response to reported complications. The U.S. Food and Drug Administration (FDA) first issued a public health notification in 2008 regarding serious complications associated with surgical mesh for POP repair. This was followed by a 2011 safety communication stating that complications were not rare, reversing its earlier position.
The FDA reclassified surgical mesh used for transvaginal POP repair from a moderate-risk Class II device to a high-risk Class III device in 2016. This reclassification required manufacturers to submit additional data to demonstrate the safety and effectiveness of the products. Following a review, the FDA determined that the benefits of transvaginal mesh for POP repair did not outweigh the risks.
In April 2019, the FDA ordered manufacturers to immediately stop selling and distributing all remaining surgical mesh devices indicated for transvaginal POP repair in the United States. This action specifically applied to mesh used for POP via the vaginal approach. The use of mesh for SUI treatment, known as a midurethral sling, was not affected by the 2019 ban and remains a common surgical option. Mesh is also still used for POP repair when placed through an abdominal approach, such as in sacrocolpopexy.