ECRI - Medical device material performance study: Polypropylene safety profile (13 October 2020)

Summary

This report by the US non-profit organisation the Emergency Care Research Institute (ECRI) was commissioned by the US Food and Drug Administration (FDA) to determine the safety profile of polypropylene (PP) mesh used in a variety of surgical procedures. ECRI performed a comprehensive literature search and systematic review to identify the current state of knowledge about how patients' bodies respond to PP mesh.

Content

Key findings

• Local host responses to polypropylene (PP) used in surgical mesh included pain, foreign body sensation, seroma and haematoma. When PP mesh was used in other surgeries (female stress urinary incontinence mesh or mini-sling, transvaginal or transabdominal prolapse mesh), the primary local responses were erosion/exposure followed by dyspareunia and pain. Studies reported these complications from immediately post surgery to five years post surgery.
• Evidence suggested that lightweight PP mesh was less likely than heavier weight PP mesh to cause pain or foreign body sensation.
• There were no studies elucidating patient– or material-related factors contributing to systemic responses.
• ECRI’s data pointed to infection in 40% of event reports associated with PP mesh. There were five deaths, and when patient harm was reported, 44% required intervention or hospitalisation.

Evidence gaps

The report identifies the following evidence gaps:

• Studies of local and systemic host response to PP as a material.
• Studies examining local or systemic host response to diaphragmatic hernia mesh.
• Better quality evidence regarding local responses such as inflammation, mesh migration, and pain and regarding systemic responses to mesh such as allergy, autoantibody development and systemic inflammation.

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