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Regulation of Vaginal Mesh as a Medical Device

November 11, 2017

On 16 August 2017 The Guardian argued that:

“the approval process for medical devices is poorly regulated in comparision to drugs: no large-scale, randomized controlled trials are required, and products can be introduced to the market rapidly – while complications may emerge only months or years later. It is time to consider a tighter regime. In the meantime, requiring long-term follow up studies to identify problems down the line could save patients suffering, without in any way holding back innovation”

 

Introduction

Vaginal mesh was implanted surgically in the treatment of incontinence and uterine prolapse. It is a kind of medical device. The definition (1) of medical devices, according to Article 1 of the Implantable Medical Devices Directive (2007/47/EC) is ‘any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  1. diagnosis, prevention, monitoring, treatment or alleviation of disease,

  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

  3. investigation, replacement or modification of the anatomy or of a physiological process,

  4. control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.’ It is not entirely biological. World Health Organization (WHO) (1) defines medical devices as everything from simple artifacts, to more sophisticated things, and to complex equipment.

 

Regulation of Medical Devices

In UK, the regulation of medical devices (2) is mainly by manufacturers themselves but is subject to the approval by an independent technical organization (notified body). The relationship between manufacturers and notified body is based on contract. Declaration of conformity includes the quality control by ISO 9000 standard and customization by EN 46000 standard. It regulates safety but not efficacy. Once the medical devices conformed to the declaration, it will be awarded CE mark and put into the market including UK and Europe. There is post-marketing surveillance and vigilance and the medical devices will be withdrawn if it proves to be unsafe. In the case of vaginal mesh implant, it was regulated by Directive 93/42/EEC on Medical Devices (MDD) that was mandated in 1998. In UK, the responsible competent authority is the Medicines and Healthcare Products Regulatory Agency (MHRA).

In the news by the Guardian, it is mentioned that the National Health Service (NHS) believes the vaginal mesh is safe. But the US Food and Drug Administration (FDA) (3) issues the safety warnings (Safety Communication) on the vaginal mesh in 2008 based on the literature review. The US Society of Gynecologic Surgeons (3) suggested that the use of vaginal mesh is only indicated on patients with perceived unacceptable risk of clinical failure using other non-mesh approaches and it needs to be performed by trained surgeons. According to the independent review on the trans-vaginal mesh implants by Scottish Government in March 2017 (4), it concludes that the majority of women having mesh surgery remained silent and they still awaits further evidence to decide on its future use.

 

Critical Comment

The regulation of medical devices is different from that of medicinal products in the sense that clinical trials especially randomized controlled trials are not possible to be carried out on medical devices. The main rationales are we could not blind the subjects in the clinical trials and it is against medical ethics to subject an individual to the ‘placebo’ medical devices. So, the only way to regulate is to adopt a watchful waiting attitude especially in the post-marketing phase. Maybe, we should consider revise the protocol of awarding the CE mark to an appropriate time frame and better to be after a certain period of post-marketing surveillance. This minimizes the risk of the residents in using the medical devices. We can also try to stringent the control of self-regulation by the manufacturers and also try to stringent the approval from the notified body. Another way is to adjust the quality and customization standards in the Declaration of Conformity so that a product of higher standard will be achieved.

When we talk about the vaginal mesh implants, we cannot forget that it is a medical problem. We must look for other alternative treatments before going into vaginal mesh implants surgeries. This is also suggested by the US Society of Gynecologic Surgeons as mentioned above. Even for surgeries, there are many choices and vaginal mesh implants may only be the last resort provided that it is a medical device that is difficult to carry out clinical trials but only monitored after putting into the market. The traditional treatments for a pelvic floor prolapse are non-surgical ones. We usually first consider lifestyle modifications such as avoiding constipation by eating a lot of fibers. Physiotherapists are usually involved in the early stage of the disease. Pelvic floor exercises are good in controlling symptoms. Even this fails, we can then consider vaginal pessary that is used to hold the pelvic organs in original place and inserted through the vaginal opening. Many a time, the symptoms of vaginal prolapse are mild and can be controlled by the above measures alone. If these conservative measures cannot control the symptoms, we can proceed to surgical means but it is not necessarily vaginal mesh implants. It can be repair of the relevant organs such as bladder, urethra, rectum, vaginal wall or even closure of the vagina opening. Hysterectomy is also an alternative. With the difficulties in regulating the medical devices and in this particular case, the vaginal mesh, we should consider all the other alternatives before proceeding to the vaginal mesh implants.

I understand the rationale of the US FDA in approving the use of vaginal mesh implants, they issue the warning based on evidence and feedback from the end users. But I agreed with the attitude adopted by the Scottish Government that is to wait for further evidence before making a final decision on whether to suspend its use or not (maybe just to tighten the control of it). Eventually, it benefits quite a number of lady patients in the local community according to the independent review by the Scottish Government. I believe they tend to adopt the similar direction by the US government by putting strict control on its use instead of suspending its use completely.

 

Citation

1. Annie Sorbie (2017-2018), Notes on Seminar 4 of Governance of Innovative Medicine: Medicines, Devices & Therapies, University of Edinburgh, Scotland.

2. Christopher Hodges (2017), The Regulation of Medicinal Products and Medical Devices. Principles of Medical Law.

3. http://www.ncbi.nlm.nih.gov.

4. http://www.beta.gov.scot.

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