In a recent report, a team of investigative journalists from the BBC revealed that mesh manufacturers and distributors did not adequately inform doctors how dangerous TVT (transvaginal tape) implants could be. The Panorama documentary programme was broadcast during December 2017 and aired a series of alarming facts.
According to a similar report published by ‘The Guardian’, doctors were unaware of all the associated risks. TVT implants are used for surgical treatment of urinary incontinence or vaginal prolapse after childbirth but have a somewhat chequered history. In 2012, TVT-Secur vaginal implants caused worrying complications; the implants had been tested on as few as 31 sheep and women before being used widely.
Within the UK, Ethicon (part of the Johnson & Johnson group) distributes supplies, including Gynecare TVT. However, the investigation explained how more than one medical manufacturer and distributor might have been involved in a cover-up. Similarly, an article in ‘The Independent’ shocked viewers with details of the perils of the frequent procedure.
Surprisingly, medical guidelines and rules may not apply to surgical placements carried out through an abdominal incision instead of via the vaginal route. The Wisbech Standard questioned the fitness for purpose of the so-called tape, which is actually a plastic mesh, in a widespread issue that affects millions of women globally.
Distinguished experts have labelled the current regulations governing the use of this type of implant as inadequate and have warned that women are at risk, according to Sky News. Professor Carl Heneghan at Oxford University, a specialist in medical evidence, has called for health bosses to set up a register of affected patients, amid calls for rigorous clinical trials to ensure patient safety.
The journalists highlighted conflicts of interest and inadequate or improper past trials, due to what they described as a regulatory system that was weak, not fit for purpose and which perpetrated an unsatisfactory situation. As the relevant professional medical body, The Royal College of Obstetricians and Gynaecologists may not have been impartial enough in its stance. A spokesperson, a Dr Linda Cardozo, seemed to echo the industry line by pointing out that all medical procedures have possible complications. She went on to suggest that a ban on the use of such meshes might limit treatment options unnecessarily. However, campaign organisers promptly pointed to her links with industry giants (including Ethicon) – under which she has acted as a consultant, apart from reports of research money payments accepted from Pfizer.
These disclosures came just one week after Canadian anti-mesh campaigner Chrissy Bradjic died, due to sepsis caused by her TVT implant. Another Sky News story detailed how Bradjic underwent such an implant in an operation after giving birth, but then suffered four years of exhausting battles against worrying and persistent infections.
Women suffering complications that occur years later have often met with rebuffs and excuses from surgeons and consultants. Over 130,000 UK women might have had such implants, while only 6,000 mesh removals (a dangerous procedure in itself) have been recorded. The latter total does not include extractions through private surgery. It seems, therefore, that this medical disaster might escalate to scales not seen since the Thalidomide scandal of the 1950s.
According to the National Institute for Clinical Excellence (NICE), the health watchdog, operations using vaginal mesh should be banned. BBC News also told how the implant meshes are made of a similar plastic to drinks bottles, a material which experts agree can become brittle over time. As the polypropylene ages, the resulting rough edges can cause excruciating pain, damage nerves and cut through internal organs including the bowel, bladder and uterus. Current guidelines from the NICE state that these implants should be used only for research, not for routine operations. Also, so-called partial snips may not have found their way into the statistical tally of removals. This latter procedure involves part of the mesh being removed to stop it cutting through the vagina.
Accordingly, NICE has been consulting and is due to publish documentation highlighting severe complications with life-changing consequences, leaving women sterile, with chronic pain and difficulty walking unaided. Unfortunately for many, any possible changes are likely to come too late for some sufferers although, fortunately, several Scottish health boards have stopped using the problematic type of mesh.
In October, ’The Guardian’ reported a Labour MP’s calls for the urgent suspension of the TVT mesh usage in patients. In turn, the Minister for Health has published new guidance but played down demands for an inquiry into the worrying saga.
Meanwhile, similar problems have occurred in Australia and the USA where, consequently, class action lawsuits are pending. While the suppliers have depicted the adverse mesh effects as only transitory, courts in Pennsylvania have heard from numerous women who have been left in constant pain, permanently unable to walk unaided and in need of mobility aids. One report even mentioned a woman’s partner suffering cuts during sex. Lurid descriptions describe the acute pain as akin to having a cheese grater inside their body, requiring painkillers including morphine etc. and inflicting desperation so intense that sufferers have been driven to spend their life savings in attempts to hasten private surgical remedies. In spite of the shocking accusations, the product distributor has nonetheless appealed against previous judgements in patients’ favour.
If you have concerns about this topic, are affected by mesh implants or wish to discuss a possible TVT compensation claim, please contact us here.