Vaginal mesh implants used to treat pelvic organ prolapse (POP) include a range of different types of mesh implanted in the pelvic floor area in a number of different ways to support the vaginal wall and/or internal organs. The mesh can be synthetic, ‘biological’ or a combination of the two and it may be absorbable or non-absorbable.
MHRA investigation into vaginal mesh implants
In light of an increasing number of adverse events and patient concerns being reported, the MHRA launched an investigation to better understand the use of these devices and the complications associated with their use.
MHRA workshop
The MHRA held a workshop in March 2012 under the chairmanship of Professor Paul Abrams, which included representatives of the Royal College of Obstetricians and Gynaecologists, the British Association of Urological Surgeons, the British Society of Urogynaecology, NICE, the University of Aberdeen Health Services Research Unit, and representatives of some manufacturers of these devices, to consider how to make this a safer procedure.
The meeting covered:
- types of vaginal mesh
- clinical experience, training and outcomes of prolapse surgery
- complications arising from the use of vaginal mesh
- NICE/IPAC guidance
- adverse event reporting
- responsibilities of involved parties (clinicians, regulators and manufacturers).
Further information on the outcomes of this workshop can be found in the section Responsibilities of the parties involved in the manufacture, regulation and surgical provision of vaginal meshes
MHRA review
In light of an increasing number of adverse events and patient concerns being reported, the MHRA launched an investigation to better understand the use of vaginal tapes/slings and meshes and the complications associated with their use.
Although MHRA have had very few reports of problems with these devices we have noted concerns about their safety that are being expressed by patients and patients’ groups. We do take the problems and issues reported very seriously and share concern for their safety, and those that have experienced unwanted complications from them.
In February 2012, the MHRA commissioned a systematic review of the available literature on the incidence of the most frequently reported adverse events associated with different meshes/tapes/slings. The results can be found on Summaries of the safety/adverse effects of vaginal meshes for prolapse
We continue to actively investigate and gathering evidence on the safety of these vaginal mesh and tape devices to better inform patients, doctors and surgeons about the risks, benefits and uses of these devices.
Adverse events that should be reported
The MHRA is still gathering information on the use and complications associated with these devices and would encourage reporting of adverse events to us.
Adverse events related to these devices that we expect clinicians to report to us include the following:
Pre-procedural
- mesh appears unsuitable to implant e.g. rough or sharp edges; too hard or brittle; not to specification
- packaging compromised affecting sterility.
Procedural related
- tape/mesh tears or disintegrates when implanting or fixing mesh in place
- bladder perforation.
Post operatively
- patient has an unexpected severe adverse/allergic tissue reaction to the mesh
- bladder perforation.
Longer-term patient follow-up
- evidence of mesh shrinkage, disintegration, hardening, brittleness
- recurrence of prolapse
- bladder perforation
- vaginal perforation
- recurrence of stress or urge incontinence
- mesh erosion/extrusion through tissues - especially where further surgery is needed for partial or total mesh removal
- dyspareunia
- persistent pelvic/groin pain.
Further information
NHS Choices webpage on treatment for prolapse of the uterus (external link).
NICE guidance
The National Institute for Health and Clinical Excellence (NICE) has produced guidance on the use of mesh for pelvic organ prolapse, which is available on the NICE website, along with summaries of the guidance produced for patients.
For the following procedures NICE guidelines state that current evidence on the efficacy and safety of these procedures is inadequate in quantity and quality. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Infracoccygeal sacropexy using mesh for uterine prolapse repair (IPG280)
- Interventional procedure guidance for healthcare professionals (external link).
- Summary of this guidance for patients and carers (external link).
Infracoccygeal sacropexy using mesh for vaginal vault prolapse repair (IPG281)
- Interventional procedure guidance for healthcare professionals (external link).
- Summary of this guidance for patients and carers (external link).
Insertion of mesh uterine suspension sling (including sacrohysteropexy) for uterine prolapse repair(IPG282)
- Interventional procedure guidance for healthcare professionals (external link).
- Summary of this guidance for patients and carers (external link).
Sacrocolpopexy with hysterectomy using mesh for uterine prolapse repair (IPG284)
- Interventional procedure guidance for healthcare professionals (external link).
- Summary of this guidance for patients and carers (external link).
For the procedure Sacrocolpopexy using mesh for vaginal vault prolapse repair (IPG283), current evidence on the safety and efficacy of sacrocolpopexy using mesh for vaginal vault prolapse repair appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance and audit.
- Interventional procedure guidance for healthcare professionals (external link).
- Summary of this guidance for patients and carers (external link).
No comments:
Post a Comment