Rapid Responses to:

FEATURE: Jeanne Lenzer Watching over the medical device industry BMJ 2009; 338: b2321 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

Take note those advocating the use of mesh in hernia repairs.

Richard G Fiddian-Green   (26 June 2009)

Dermal Fillers are also Medical Devices!

Nigel S G Mercer   (13 July 2009)

Take note those advocating the use of mesh in hernia repairs. 26 June 2009
Richard G Fiddian-Green, FRCS, FACS. None Send response to journal: Re: Take note those advocating the use of mesh in hernia repairs.	Five years ago I wrote, in addressing the use of mesh in herna repairs, "Inserting an open mesh in a patient is akin to inserting a limpet mine. It may never be hit by a ship but if it is it could sink it. The risk is of infection developing in the mash latter years during the course of another illness, such as an AP resection which requires the formation of an adjacent colostomy or admission to an ICU for organ dysfunction. In the latter instance the mesh could become an occult nidus of infection that kills the patient" (1). In examing the risks of herniorrhaphy further I also wrote, "One of the risks in doing a herniorrhaphy is causing infertility by obstructing the vas deferens. The incidence of obstruction, which may be reversible, is reported to be as high as 26.7% in subfertile patients with a history of childhood herniorrhaphy. Furthermore "immunoglobulin (Ig)G and IgA class antisperm antibodies, which contribute to infertility, have been found to be positive in 55% and 18% of those patients with a vasal obstruction caused by inguinal herniorrhaphy and in 60% and 20% of vasectomized patients respectively; whereas these antibodies were positive in 13% and 0% of those patients with an epididymal obstruction of unknown etiology and in 8% and 3% of those patients with congenital bilateral absence of the vas deferens"....In looking at the problem from a different perspective "10 infertile men found to have sperm-agglutinating antibodies in serum and a history of inguinal herniorrhaphy the site of the previous operation was explored. Five of the men had an occlusion of the vas deferens and in three others spermatoceles were noted in the epididymis. The occlusion of the vas deferens was in the area of the previous herniorrhaphy". If obstruction of the hard-walled vas can occur so commonly what of arterial and especially venous obstruction? Is it not likely to be far more common even if not manifest as a varicocele?"(2). Hernia repairs are bread-and-butter for those in private practice and are a significant cost and major headache for managers in the NHS and VA hospitals in the US because of the difficulty in getting consultants to clear their waiting lists. Its a contraversial subject. Some, such as Professor Meakins, are very conservative advocating that surgery be restricted to those that become symptomatic. Four years ago, the Department of Health asked Professor Meakins, then Nuffield Professor of Surgery at Oxford, to write a list of criteria for hernia surgery. "He concluded that repair should be offered only when the hernia is painful and growing; where the patient has a history of complications; where the patient's job is dependent on the repair, or if the patient demands it" (3). He admits to having had hernias himself for decades and having had nothing done about them. Professor Hobsley, another advocate of a more conservative approach, tried to obtain a factual basis for a wat-and-see policy. "The cumulative probability of strangulation in relation to the length of history has been calculated for inguinal and femoral hernias presenting to this hospital between 1987 and 1989. Of 476 hernias (439 inguinal, 37 femoral), there were 34 strangulations (22 inguinal, 12 femoral). After 3 months the cumulative probability of strangulation for inguinal hernias was 2.8 per cent, rising to 4.5 per cent after 2 years. For femoral hernias the cumulative probability of strangulation was 22 per cent at 3 months and 45 per cent at 21 months" (4). Thus not only does the use of a mesh in hernia repairs create a risk of septic problems that can be difficult to manage but may also create risks of other very significant complications. If I were to have an inguinal hernia that required repair I would be extremely reluctant to have it repaired with a mesh. The same kind of case can be made against haemorrhoidectomies and varicose vein stripping and/or percutaneous treatments. Much of the bread-and-butter surgery in private practice may be unnecessary. 1. Poor solutions for poor surgery. Richard G Fiddian-Green (11 January 2004) Rapid response to: Andrew Kingsnorth. Treating inguinal hernias. BMJ 2004; 328: 59-60. 2. Are mesh repairs causing infertility and other urogenital disorders? Richard G Fiddian-Green bmj.com, 5 Dec 2004. Rapid response re: H D E Atkinson, S G Nicol, S Purkayastha, and S Paterson-Brown Surgical management of inguinal hernia: retrospective cohort study in southeastern Scotland, 1985-2001 BMJ 2004; 329: 1315-1316 3. Why are men being refused surgery for their hernias? By Victoria Lambert. Mail on line, Thursday, Jun 25 2009. 4. N. C. Gallegos, J. Dawson, M. Jarvis, M. Hobsley. Risk of strangulation in groin hernias British Journal of Surgery Volume 78 Issue 10, Pages 1171 - 1173 Competing interests: None declared
Dermal Fillers are also Medical Devices! 13 July 2009
Nigel S G Mercer, President of the Bristish Association of Aesthetic Plastic Surgeons (BAAPS) Bristol, BS1 4LF Send response to journal: Re: Dermal Fillers are also Medical Devices!	The 'fog' which shrouds the Medical device industry in the UK is perhaps best shown by Injectable Dermal Fillers which are registered as "Devices" rather than prescribable medicines. The products only require CE marking, which relates to standards of production and not to efficacy, to be released onto the UK market, whereas in the USA they have to be FDA approved as medicines, not devices. In consequence, we have over 140 injectable fillers on the market in the UK compared with 6 FDA approved fillers available in the USA. The lack of regulation in th UK means that they do not need to be prescribed by a doctor and that anyone can inject these substances! As a consequence, BAAPS members have seen an alarming number of cases where patients have suffered real and significant harm from injection of fillers into the wrong site, with devastating consequences for the individual. The terms 'semi- permanent' or 'permanent' filler relate to the chemical constituents. They do not produce a permanent correction as the public often thinks. There is no doubt that adoption of FDA approval and the re- classification of Dermal Fillers as prescribable medicines would remove many of the patient problems. The British Association of Aesthetic Plastic Surgeons (BAAPS) surveyed it's members earlier this year, and 96% of our members want the Government to adopt FDA approval for dermal fillers. Unfortunately, the Department of Health is determined that this area of medicine must be left to market forces to self regulate on the basis that it would be too costly and that correction of the problems caused has a minimal cost to the NHS. In 1968 the Government passed a law controlling tattooing in the UK on the grounds of public health. In terms of volume, this market is much larger than tattooing and it does need regulation to reduce the real risks of harm to the population. Competing interests: None declared