If we look at the FDA’s statement on vaginal mesh, which was released in 2011 and so is out of date, we can see that 2% of women will suffer mesh erosion. That indicates that one in 50 women will have the issue. When the FDA issued this information in 2011, along with their warnings regarding mesh for Pelvic Organ Prolapse, they stated that “The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date”. The result of this evaluation has yet to be released.
Meanwhile, in September 2017, a new study was released and reported to be the largest ever into complications following vaginal mesh to treat SUI. This was an 8 year study of 92,246 women. The conclusion was that 9,8% of all women undergoing mesh surgery to treat SUI are likely to suffer complications between 30 days to 5 years after initial insertion. That is almost one in ten women suffering adverse effects from mesh. This is unacceptably high.
HAVE THERE BEEN LONG TERM STUDIES INTO MESH SLINGS FOR SUI?
The longest follow-up for mesh implantation is a multi-centre Scandinavian study with follow-up over 17 years. The study began with a small sample of just 90 women, which for Scandinavia should demonstrate statistical significance (assuming 10% margin of error with 95% confidence level). The conclusion of the study was that “The TVT operation is durable for 17 years, with a high satisfaction rate and no serious long-term tape-induced adverse effects”. Sounds great right?
What happens if look beyond the conclusion to the actual data? We find that only 55 of the 90 in the study group were available for the 17 year analysis (61%). Of these 55 women, 12% reported worsening symptoms or no change compared to pre-surgery conditions. Of the 55, only 46 could present for physical examination. One of these ladies was found to have mesh erosion on physical exam, thats 2% of the group that made it for physical exam. On reading further, we find that two of the authors admit conflicts of interest.
CONTROVERSY AROUND POLYPROPYLENE
All mesh products are made with a type of plastic called Polypropylene, sometimes referred to as Prolene. This is the same material used to make plastic packaging, carpet backing, woven bags and synthetic ropes. In the recent 60 minutes documentary, plastics expert Duane Priddy explained that polypropylene is not suitable for permanent implantation in the human body. Polypropylene mesh devices typically have antioxidant additives to prevent them from breaking down. These antioxidants break down over time, and once dissipated, oxygen will begin to break up the polypropylene. Chevron Phillips, the supplier of the polypropylene used by many of the mesh manufacturers, issued a warning in 2004 explaining that it should not be used for permanent implantation in the human body, and yet it continued to be used. Boston Scientific refused to be interviewed on the documentary but did issue a statement in response denying all allegations.
HOW DO MESH SLINGS COMPARE WITH AUTOLOGOUS FASCIA SLINGS?
There have been many studies comparing the use of synthetic slings to fascia slings. We have extrapolated the results of three of the studies that do not show conflicts of interest:
A 2004 study found that Synthetic slings are 15 times more likely to extrude into the urethra and 14 times more likely to erode into the vagina compared to non-synthetic slings.
A 10 year multi-centre randomised controlled trial comparing slings (TVT mesh, Xenograft and Autologious fascial) concluded that “there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However, there is some evidence that ‘dry’ rates for AFS may be more durable than TVT.”
A 2016 study exploring existing studies into Autologous Pubovaginal slings (AFS) concluded that “autologous PVS is an effective and safe option for surgical treatment of primary and secondary SUI. It can be safely performed with a low morbidity rate and a negligible erosion risk in comparison to synthetic slings.” and suggested that clinicians receive training in both procedures.
HOW CAN I DECIDE IF MESH IS RIGHT FOR ME?
All mesh implants are permanent and adverse events are common. Adverse events include:
- difficulty urinating
- de novo urgency (new incontinence)
- frequent urinary tract infections
- mesh erosion into the urethra or vagina
- mesh erosion into the bladder
- irritation, inflammation and infection
- painful intercourse
- pain in the hips and legs
- mobility issues (some women require wheelchair)
Mesh is implanted to replace damaged fascia (your body’s connective tissue). It is expected that scar tissue will form around the mesh thus bringing bulk and support. Mesh is not supposed to shrink or change shape, and yet many removals show that the devices have shrunk by up to half their size. If you experience issues with your mesh, your surgeon will be very reluctant to remove it. Many surgeons will offer partial removal, citing full removal as too dangerous, however, those who have partial removals typically end up back on the operating table again for further surgeries. Each surgery creates more damage to surrounding tissues creating more scar tissue and increasing the risk of damaging organs within the pelvis (bladder, bowel etc.).
With all these facts to hand, the decision to have mesh implanted is not one to be taken lightly. If you do decide to take the risk, make sure your surgeon has a plan for what to do should you be that 1 person in 10 for whom things go disastrously wrong following your surgery.