WHY ANCHORLESS

THE PROBLEM

Existing transvaginal implants (TVM) are associated with severe safety risks, including:
  • Pain
  • Erosion
  • Infection
  • Dyspareunia
  • Urinary Dysfunction
  • Repeat Surgery
  • De Novo Stress Urinary Incontinence

LET’S FACE MESH

At Lyra Medical, we understand that these complications stem mainly from the need to anchor transvaginal mesh into the pelvic structure, regardless of the specific anchoring technique used. Literature supporting this conclusion clearly shows that:

  • Scar tissue accumulation causes the mesh to fold, bulk and contract, significantly increasing the probability of post-operative pain, dyspareunia, mesh erosion and prolapse reoccurrence. Reducing the tension applied on the mesh at the fixation points has been shown to resolve symptoms in 90% of patients1.
  • Past techniques that did not involve anchoring (such as graft augmented colporrhaphy – mesh reinforced native-tissue repair, and J&J’s Prosima Pelvic Mesh) did not involve pelvic pain.
  1. Complications of pelvic organ prolapse surgery and methods of prevention. Int Urogynecol J (2013) 24:1859-1872

EXISTING SOLUTION DRAWBACKS

OPEN YOUR MIND, OVERCOME FIXATION

With the understanding that it is not the mesh, but the anchoring, that is responsible for the risks involved in the transvaginal approach, we have developed an anchorless implant that eliminates all fixation-related complications.

Learn more about our Self-Retaining Support Implant
SRS implant

TVM HISTORY SNAPSHOT

2008

FDA INITIAL CONCERN

2011

FDA ADVISORY PANEL

2014

FDA MODIFIES SUCCESS CRITERIA

2016

FDA Reclassification

2019

FDA Stops US Sales

FDA adopts modified success criteria for assessing Native Tissue Repair (NTR) vs. TVM, improving NTR success definition while compromising anatomical outcomes
FDA convenes advisory panel to discuss TVM complications
FDA adopts modified success criteria for assessing Native Tissue Repair (NTR) vs. TVM, improving NTR success definition while compromising anatomical outcomes
FDA reclassifies surgical mesh for transvaginal repair of pelvic organ prolapse as class III
TVM manufacturers Boston Scientific and Coloplast fail to meet FDA requirements and are ordered to immediately stop selling and distributing their solutions