What is all this mesh controversy about?
Recently there has been quite a few articles originating from Great Britain regarding bladder sling surgery for stress urinary incontinence and associated complications. Some women in South Africa are choosing to live with the indignity of incontinence because they are misinformed about the treatment options available to them and are afraid of the complications that can occur with mesh products.
“We are getting more and more women phoning our practice saying that they are afraid of surgery because of articles they have read in the news and on the internet,” says Jana Thiart, office manager for Drs Jeffery and Kruger who are subspecialists in the field of Urogynaecology. “We even had one woman who phoned at 10pm to cancel her surgery scheduled for the next morning because of an article her sister-in-law had read.”
It is true that certain mesh products are problematic and have been withdrawn from the market. And, if a doctor is not sufficiently experienced or well trained, mesh surgery – as with any surgical procedure - can result in complications.
But that is only part of the story, according to Dr Stephen Jeffery, who also heads the Urogynaecology Unit at UCT’s medical school and is the immediate past president of the South African Urogynaecology Association.
“Tension –free Vaginal Tape (TVT) was first used in Sweden in 1997,” said Dr Stephen Jeffery, who heads the Urogynaecology at UCT’s medical school. “It was widely recognised as being one of the most significant innovations of our time and has had a positive outcome for thousands of women.
“But patients need to understand that there are two very different mesh products. The sling is very narrow and is a safe and effective treatment for many cases of incontinence. The product that was recalled by Johnson and Johnson is the Prolift, a much bigger and more invasive device that is specifically used for vaginal prolapse and not urinary incontinence.”
Dr. Kruger who shares a practice with Dr. Jeffery and is currently the Urogynaecology fellowship director at Groote Schuur Hospital agrees with Dr. Jeffery. The complications of mesh surgery are well known and should be discussed with patients. The common complications are mesh erosion and chronic pain and that can vary between 1-10%. A lot of the complications related to mesh surgery can be avoided by training subspecialist in urogynaecology and choosing the correct procedure for the individual patient. Patients should feel comfortable that their physicians have explained the risks and complications related to their specific treatment in detail and that their physician has the necessary experience to deal with complications when they arise.
Female urinary incontinence can have a severe effect on the quality of life of the individual. The majority of patients benefit greatly from vaginal mesh slings to treat stress incontinence and hospital stay and post-operative pain have been reduced dramatically because of the less invasive nature of this type of treatment.
At the end of the day, like with any other procedure, the patient needs to decide if the risk-benefit ratio of transvaginal mesh surgery for stress incontinence is something they feel comfortable with.
For Drs Jeffery and Kruger, in a perfect world, vaginal mesh procedures would only be performed by accredited urogynaecology sub specialists. In South Africa, however, many doctors are doing the operation, some with very little experience in this type of operation.
The Federal Drug Administration in the US responded to the concerns about mesh in January 2012 by calling for Post Market Surveillance of the products. As part of this procedure, every patient that had been fitted with mesh is followed up by an independent clinical research company and a comparison is made between those patients who received mesh kits and those who had other corrective surgery. Companies are not obliged to take part, and Johnson & Johnson, which had been the biggest supplier of mesh until they withdrew their product, declined. Two of the companies that supply mesh products in South Africa – Boston Scientific and Coloplast – made the substantial investment in the trials.
In the case of Coloplast, an erosion rate of less than one percent was reported – a result that is substantially lower than the risk associated with any surgical procedure.
The results highlighted the importance of adequate training for surgeons performing vaginal mesh procedures, and emphasised the need for ‘hands on’ experience. Simple observation is not enough to ensure competence.
Dr Jeffery suggests that anyone considering surgery for prolapse or incontinence should ask her doctor the following questions:
What are the complications of the procedure?
What are the complications of the alternative?
What are the success rates of the operation?
How many of these operations have you performed yourself?
The largest associations in the world that deal with female pelvic floor dysfunction agrees. Please see the position statements of these organizations:
- IUGA
- AUGS
- USANZ