Pelvic mesh is a medical device designed for permanent implantation to provide structural support to weakened pelvic tissues. The mesh is typically a net-like sheet composed of synthetic polypropylene material, though some versions use animal-derived biological tissues. Its primary surgical applications are to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). For SUI, the mesh is placed as a narrow sling beneath the urethra to support the bladder neck and prevent urine leakage. For POP, the mesh is used as a larger graft to reinforce the vaginal wall and hold prolapsed organs, such as the bladder, uterus, or rectum, in their correct anatomical position. While intended to offer a durable solution for these common conditions, the use of these devices has been linked to a range of adverse events that have become the focus of extensive medical and regulatory scrutiny.
Specific Physical Complications and Patient Symptoms
Mesh erosion, also termed extrusion or exposure, occurs when the mesh material moves or pokes through the wall of the vagina or other surrounding organs. This exposure can lead to symptoms like abnormal vaginal discharge or bleeding. When the mesh erodes into the vaginal canal, patients often report feeling a rough or sharp material. The condition can also cause pain during sexual intercourse (dyspareunia) for both the patient and their partner.
Chronic pelvic pain is a common complication, manifesting as persistent discomfort in the pelvic area, groin, or radiating into the back and inner thighs. This pain can stem from nerve entrapment, inflammation, or the mesh material shrinking over time. Mesh contraction creates abnormal tension on surrounding tissues, causing a noticeable pulling sensation. This generalized discomfort can severely diminish a patient’s quality of life.
Infection is a serious physical complication because the foreign body material can create a persistent site for microbial colonization difficult to eradicate with antibiotics alone. Infections may lead to localized inflammation, abscess formation, or the development of a fistula, such as an abnormal connection between the bladder and the vagina. Urinary tract complications are also common, including voiding dysfunction, which makes it difficult to completely empty the bladder. This dysfunction often leads to recurrent urinary tract infections (UTIs).
The insertion process or subsequent migration of the mesh can result in organ perforation. This occurs when the mesh or surgical tools cause a hole in the bladder, bowel, or urethra. Symptoms of organ damage often include hematuria (blood in the urine) or severe bowel problems, depending on the site of the perforation.
Medical Diagnosis and Treatment Options
The medical evaluation of suspected mesh complications begins with a comprehensive physical examination, including a detailed pelvic exam. Clinicians check for visible mesh exposure in the vaginal wall, signs of inflammation, scarring, or palpable mesh material. This initial assessment helps determine the severity and extent of the complication.
If the physical examination is inconclusive, various imaging procedures confirm the mesh’s location and integrity within the pelvic cavity. Translabial or transanal ultrasound provides detailed images of the mesh and its relationship to soft tissues, helping to identify erosion or migration. For complex cases, magnetic resonance imaging (MRI) or computed tomography (CT) scans assess deeper structures and confirm organ involvement, such as bowel or bladder perforation.
Treatment options range from conservative methods for minor issues to extensive surgical intervention. Conservative management typically involves topical vaginal creams to treat minor mesh exposure by improving tissue health. Pain management specialists may prescribe oral medications for nerve pain or muscle spasms, and pelvic floor physical therapy is often recommended to address muscle dysfunction.
If symptoms are severe or persistent, surgical removal of the mesh is often necessary, though this procedure requires specialized expertise. Surgery may involve a partial excision of only the problematic segment, or a complete removal. Complete removal is challenging because the patient’s native tissue grows into the mesh, making it difficult to separate the material from vital organs without causing further injury.
Surgical removal carries risks, including heavy bleeding, injury to nearby organs, or a worsening of pre-existing symptoms like incontinence or chronic pain. Patients must understand that removal does not guarantee symptom improvement; many individuals still experience pain even after the material is fully excised. Due to the difficulty and potential for adverse outcomes, patients are often referred to specialized multidisciplinary centers.
Regulatory Oversight and Patient Recourse
The history of pelvic mesh use has been marked by significant regulatory actions by the U.S. Food and Drug Administration (FDA). In 2016, the FDA reclassified transvaginal surgical mesh used for Pelvic Organ Prolapse (POP) repair from a moderate-risk Class II device to a high-risk Class III device. This change placed more stringent premarket requirements on manufacturers to prove the safety and effectiveness of their products.
Following this reclassification, the FDA ordered manufacturers in April 2019 to immediately stop the sale and distribution of surgical mesh intended for transvaginal POP repair. The agency determined that manufacturers failed to provide sufficient evidence demonstrating the devices’ safety and long-term effectiveness. This action effectively removed transvaginal mesh products for POP from the market, though mesh used for SUI remains available.
For patients who experience complications, the FDA maintains the MedWatch program, the official adverse event reporting system for medical devices. This voluntary system allows patients and healthcare professionals to submit reports detailing problems encountered with the mesh. The data gathered through MedWatch contributed directly to the heightened scrutiny and subsequent regulatory actions against POP mesh devices.
Many affected patients have sought legal recourse through mass tort litigation against the manufacturers of the mesh devices. Tens of thousands of lawsuits claim the devices were defectively designed or that manufacturers failed to adequately warn about the risks. These legal avenues provide a pathway for patients to seek compensation for their injuries, medical costs, and diminished quality of life resulting from mesh complications.