TVT – What is it?
TVT (or Tension-Free Vaginal Tape) is a woven polypropylene mesh designed to support the mid-urethra to prevent stress incontinence. The mesh strip is a permanent implant which is inserted transvaginally under the urethra to provide extra support during times of increased abdominal pressure such as when coughing or sneezing. Many UK NHS hospitals use the Gynecare TVT retropubic tape which is manufactured by Ethicon, a subsidiary of Johnson & Johnson. Other variations on this tape are TVT-Secur, TVT-O, and TOT. There are other brands of synthetic sling similar to TVT produced by other manufacturers.
Synthetic meshes made of the same material may also be implanted transvaginally during surgery to treat pelvic organ prolapse in order to support the pelvic organs (bladder, uterus and rectum) and help prevent them from slipping down into the vagina. Mesh may also used to treat some cases of hernia.
Synthetic meshes have been shown to be no more effective than other non-mesh surgery but doctors carry on implanting it because the training, operating, and recovery times are much quicker than traditional surgery.
What’s the Problem?
Women are often not told of the long term risks and lack of long term data on the safety of TVT. The surgery is described in the manufacturer’s literature as “safe, effective and minimally invasive”. However, these meshes are causing serious complications in many women. In additional to the usual operative risks associated with gynaecological surgery, the mesh can cause all sorts of problems, such as: urinary retention and bladder emptying problems; urine infections; nerve and pubic pain; painful intercourse; erosion of the material into the bladder, vagina and other organs; infection and abscess; urge incontinence; and foreign body reaction.
There are studies which show that mesh is not inert and can shrink, degrade and migrate inside the body. Some women have had multiple surgeries to remove portions of the tape which have eroded into the vagina, pelvic tissues or organs, causing pain and infection.
This device becomes firmly implanted in the body once the fibroblasts have infiltrated the mesh at around 6 weeks. Unlike hip or breast implants, it becomes very difficult and sometimes impossible to remove. Removal can be risky too because it risks further damage to the delicate organs such as the bladder and urethra. Many women have had trouble finding the right treatment to remedy their problems. There are very few surgeons in the UK who are experienced in removing this mesh because it is a very specialised and highly skilled procedure to remove it, yet there are numerous gynaecologists, urogynaecologists and urologists implanting it in hundreds of women up and down the country.
What’s happening in the US?
In America, the US Food and Drug Administration (FDA) has issued warnings about the use of mesh in pelvic organ prolapse and stress urinary incontinence. Since then, hundreds of lawsuits have been filed against the manufacturer. The FDA is considering reclassifying the device. They are ordering post-marketing surveillance studies be carried out by the manufacturers.
What’s happening in the UK?
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice and convened a workshop and a paper commenting on this device. It recognises the health issues surrounding this implant but its recommendations do not go anyway near enough to controlling the indiscriminate use of this device. Women are not being told that there are alternatives to mesh, such as traditional surgery using stitches, or conservative treatment such as pelvic floor therapy. They are not being told of the full nature of the risks and the lack of long term data on its safety.
There is a lack of reliable data on the safety of these devices. The real rate and full nature of complications are unknown. The MHRA has a voluntary reporting system for adverse events but this relies on patients and doctors reporting any complications and so is dependent on the honesty and compliance of doctors and the computer literacy and general savvy of patients. Reporting is not made easy because the MHRA ask for the device serial number and model number and this involves the patient applying for their medical records, which is a further barrier and can take weeks/months plus the patient may incur costs. There has been a call for a national registry to monitor the number and nature of complications but the MHRA seem a long way off implementing this.
Why are surgeons putting them in?
There are few surgeons who are willing to speak out against the tape because it was considered “revolutionary” when it first appeared over 10 years ago with limited data on its long term safety, and it has become so widely used now, being quick and relatively easy to perform compared to traditional surgery. Surgeons might be seen as dinosaurs if they do not use this new technique.
Also, there are the National Institute of Clinical Excellence (NICE) guidelines (CG40 2006) which appear to promote this surgery as the recommended treatment option for stress incontinence : “Retropubic mid-urethral tape procedures…with macroporous (type 1) polypropylene meshes .. are recommended as treatment options for stress UI where conservative management has failed. Open colposuspension and autologous rectus fascial sling are the recommended alternatives when clinically appropriate”. However, the guidelines acknowledge that evidence is limited: “Many procedures have been described for the treatment of stress UI; although there is no strong evidence of superior effectiveness of any one, the best available data support the use of retropubic mid-urethral tape procedures, colposuspension and autologous rectus fascial sling.” Perhaps a key factor here is that “retropubic mid-urethral tape procedures consume fewer hospital resources and are associated with faster recovery than the other two procedures”. (NICE Guidance CG40 2006)
Another factor influencing the use of these devices is the aggressive marketing by the manufacturing companies (such as Gynecare Ethicon) who make vast profits from the sale of these devices. They sponsor and exhibit at major professional conferences attended by respected gynaecologists, urogynaecologists and urologists. They run symposia or satellite sessions at these conferences. They fund studies and research into these implants. They pay for surgeons to act as travelling professors.
Despite these pressures, there are still some doctors who are willing speak out against the widespread use of synthetic mesh, and some who are now recognising the unique and lifelong risks presented by synthetic mesh and are no longer implanting it.
Why haven’t I heard about this issue?
It is difficult for women to talk openly about their surgery because bladder problems are a taboo subject in our society, but stress incontinence is a very common problem in women of all ages, particularly in women who have had children. Unlike hip or breast implants, the subject of implants for stress incontinence has not been widely discussed, perhaps because people are embarrassed to talk about their surgery and complications to their family, friends and colleagues. However, more and more women are now using support sites and the internet to help each other and are voicing their concerns and canvassing the government and health officials to do something about the indiscriminate and uncontrolled use of these intrinsically unsafe devices.