Medical Reports & Case Studies

Meshes, Law and Enuresis

^*Correspondence: Rebeca Stones, Editorial Office, Medical Reports and Case Studies, France, Email:

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Editorial

Urologist and gynaecologist treatment of female urine incontinence is a widespread practise. When a gynaecologist is consulted about a patient's true stress incontinence, they are likely to have some type of surgical intervention. If the outcomes are unsuccessful, the patient is sometimes referred to a urologist as a "refractory case." Over the past 15 years to 20 years, meshes, whether placed directly or by laparoscopy, have undergone a paradigm shift in the principal intervention performed by gynaecologists. This editorial is concerned with the rising number of clinical problems that are being reported, as well as the medical-legal disputes that have resulted from using such meshes to treat female incontinence. Whether abdominally or, more frequently, vaginally, mesh application, the immediate postoperative results are frequently very impressive. Unfortunately, the longterm effects have frequently resulted in court cases that are of epidemic proportion, in addition to making huge headline news. A few of these complications include migration of the mesh with penetration of the colon and/or bladder, crippling abdominal pain, local infection, dyspareunia, and persistent heavy and uncontrollable vaginal discharge and/or vaginal bleeding. In an effort to remove the mesh, among other things, some of these issues have required additional surgery, though not always with successful outcomes [1]. The introduction of vaginal meshes, essentially took off significantly in the 1990’s. Previously, the gynaecologist used the body’s own tissues to correct both stress incontinence and utero-vaginal support. The increasing use of meshes was meant to parallel the use of meshes in hernia repairs. One can also understand that the use of a minimally invasive procedure requiring minimal hospitalisation, short anaesthetic period and immediate and impressive continence control made the procedure a most attractive one for surgeons, gynaecologists or urologists. Operations, like the Burch colposuspension, previously the golden standard of female GSI corrective surgery, suddenly appeared antediluvian. Naturally, an element of “not falling behind one’s peers” can never be separated from the motivating factors. In the USA, where more than 60,000 lawsuits have been filed over the past 15 years or more, the number of pelvic mesh complaints tripled between 2008 and 2010 compared to the previous 3 years. Medical liability lawsuits resulting from serious effects were reported in several different nations [2]. For instance, the Scottish NHS is currently dealing with the most concurrent medical negligence proceedings in legal history, with over 400 cases filed before the Court of Session in Scotland. Liability decisions still need to be made with a massive amount of resulting medico legal issues. Following such issues, Johnson & Johnson, C.R. Bard, American Medical Systems, Boston Scientific, and Coloplast all reached significant financial settlements. Yet mesh producers insist that they introduced these goods to the market with the justification that they were an efficient and secure means of treating stress urine incontinence and pelvic organ prolapse. Nobody, in my opinion, has any qualms about these goals. But the truth is what it is. Since 2008, when the Food and Drug Administration warned of potential risks, there have also been warning lights. The FDA received 2874 more reports of problems related to surgical mesh devices used for stress incontinence correction and pelvic floor reconstruction from January 2008 through December 2010, with 1503 reports related to the former and 1371 reports related to the latter. In 2011, the FDA's Medical Device Advisory Committee came to the conclusion that, depending on the precise vaginal area being repaired, there may be no benefit above the conventional repair and that the safety and risk/benefit of such meshes are not well established [3]. The last warning may be legitimately disputed on its own, given that there are unquestionable benefits to a minimally invasive technique over, instance, a Burch colposuspension, as long as the risk/benefit ratio was acceptable. The FDA upgraded the risk category in 2016 from moderate to high risk. Mesh-oriented liability law may be quite difficult to understand. This challenge extends beyond determining who is liable for medical malpractice involving botched surgery vs a product's inherent flaw. However, the two components may not always be mutually exclusive and may coexist. Therefore, both a harmful product and its implantation could be influenced by an inexperienced surgeon, or even by any surgeon in an inexperienced manner. Examining the degree of pre-patient training and the learning curve of the particular surgeon in issue are among the things to consider. A general gynaecologist executing his first dozen mesh insertions after watching one or two cases and a DVD is vastly different from a urologist who has performed several hundred mesh insertions or a gynaecologist who has sub-specialized in uro-gynecology. A mesh that is intrinsically defective may nevertheless result in a finding of medical culpability, especially in light of the FDA warnings mentioned above [4]. This is true even if the element of surgical technical negligence is omitted. Another strong and difficult-to-overcome argument may also result in medical culpability on its own. This is due to the growing importance that the Court has given to the patient's disclosure of medical information (in this case, preoperative information). Along the line of ever-increasing patient autonomy in choosing or accepting medical care, this has attained new and nearly supreme status. A significant decision in this regard was made by the UK Supreme Court in the case of Montgomery. Lanarkshire Health Board (Respondent) (Scotland) [2015] UKSC 11. It is sufficient to say that, among other things, the Bolam principle's application to the disclosure of medical information has been eliminated as a result of this case. The question of what a reputable group of peer doctors would have done in these circumstances will no longer be raised in court. It now largely comes down to, among other things "doctor, before inserting the mesh, did you adequately inform your patient of all potential risks?

References

1. Bachet, M. "The concept of encéphaloses criminogènes (criminogenic encephalosis)." Am J Orthopsychiatry 21.4 (1951): 794.

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2. Altus, W. D. "Some correlates of enuresis among illiterate soldiers." J Consult Psychol. 10.5 (1946): 246.

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3. Subasinghe, D., et al. "Neurofibroma invading into urinary bladder presenting with symptoms of obstructed defecation and a large perineal hernia." BMC surg. 14.1 (2014):1-4.

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4. Han, E., et al. "Effect of hormonal changes on voiding in the elderly woman." Curr Bladder Dysfunct Repor 10.4 (2015): 362-369.

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