Published: 25 September 2018
Reviewed: 7 May 2019
Medical Devices
Surgical Mesh Implants - Overseas Actions and Reviews
United States of America
On 16 April 2019 the US Food and Drug Administration (FDA) announced that
it was taking action to remove all remaining products indicated for the
transvaginal repair of pelvic organ prolapse from the market. The companies
were given ten days to submit a plan to withdraw the products from the US
market. This is consistent with the actions taken by the TGA in Australia
and Medsafe in New Zealand in December 2017/January 2018.
Australia
The Australian Inquiry was specific to harm subsequent to surgery where surgical mesh was implanted. The report noted that many patients had reported benefits from surgical mesh surgery, but these were not included in the report as they were out of scope of the review.
The Australian Senate commissioned an inquiry to: identify how many women in Australia have been adversely affected following transvaginal mesh surgery; consider the information and support provided to women undergoing such surgery; consider the information provided to doctors and surgeons recommending and performing these surgeries; and to examine the role of the Therapeutic Goods Administration (TGA) in Australia in approving and monitoring the surgical mesh devices used in these surgeries.
The Senate Community Affairs References Committee Number of women in Australia who have had transvaginal mesh implants and related matters report was published 28 March 2018. https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report This report included thirteen recommendations. These align very closely with the recommendations of the New Zealand Health Committee in its report published on 1 June 2016. https://www.parliament.nz/en/pb/sc/reports/document/51DBSCH_SCR69220_1/petition-20110102-of-carmel-berry-and-charlotte-korte
Two of the recommendations were not included in the New Zealand Health Committee report but are included in the programme of work that is currently underway in New Zealand associated with the Mesh Round Table. These are in relation to informed patient consent and treatment care pathways. The report also acknowledges the feedback that the “vast majority of women who have had trans-vaginal mesh procedures as part of treatment for stress urinary incontinence(SUI) or pelvic organ prolapse (POP) have not experienced complications as a result of their surgery and have experienced improved quality of life”.
The Australian Therapeutic Goods Administration (TGA) conducted a review into urogynaecological surgical mesh implants. On 22 December 2017 it announced a series of regulatory actions in relation to transvaginal mesh products and single incision mini-slings. These actions included issuing cancellation notices from the Australian Register of Therapeutic Goods (ARTG) and notices to impose conditions in relation to other mesh and sling products. https://www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants
United Kingdom
The United Kingdom inquiry was more focussed on clinical training and recommended a pause in use to enable training. No safety issues with the mesh devices were identified, and no regulatory action was proposed to remove devices from the market.
In England the Independent Medicines and Medical Devices Safety Review was published on 10 July 2018. This recommended a pause in the use of vaginally inserted surgical mesh for stress urinary incontinence (SUI) until a set of conditions to ensure that patients receive safe and high-quality care are met. This pause has been extended to include vaginally inserted surgical mesh for pelvic organ prolapse. The government and National Health Service (NHS) have accepted the recommendations in the report. The scope of the pause has been extended to include Ireland.
These procedures have not been banned, and can still be used during the pause when there is no viable alternative. There has been no new evidence to prompt regulatory action to remove products from the market.
In Scotland the government called for the use of mesh implants to be suspended while an independent safety review was carried out, in June 2014. The Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women report was published in March 2017. https://www.gov.scot/Resource/0051/00515852.pdf
In August 2018 the Scottish Parliament confirmed that the suspension in use should remain in place as the necessary work on implementation of the recommendations around clinical use had not been completed. This work aligns with the UK Government recommendation that the use of surgical mesh for SUI is paused to allow the recommended training and credentialling of clinicians to happen.
Mesh for SUI can still be used in the UK and Scotland, there has been
no regulatory action taken in regard to the products. Rather, a clinical
recommendation around its use only in selected patients by trained clinicians
has been made.
The PROSPECT (PROlapse Surgery; Pragmatic Evaluation and randomised Controlled Trials) study was a parallel group, multicentre (35 centres in the UK) randomised controlled trial that studied women undergoing primary transvaginal anterior or posterior compartment prolapse surgery using either native tissue repair alone with repair augmented with either synthetic mesh or biological graft. The primary outcomes were measured at one and two years post surgery.
The study found no significant differences between standard native tissue repairs and repairs augmented by mesh in any of the primary or secondary outcomes formally analysed during the time period of the study. Further study in this area was a recommended outcome from the trial.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31596-3/fulltext
