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Medical devices: FDA ends secret reporting system that hid failures

BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l2097 (Published 08 May 2019) Cite this as: BMJ 2019;365:l2097

Rapid Response:

Mind the gaps in institutional regulation of devices and procedures

Dear Editor

Men have previously believed that prostate cancer screening ‘works’ safely, but recent evidence disputes this (1). Sir Mike Richards recently called for a halt to PSA screening (2) as no benefit results. The public should be given better information (3) and ask more difficult questions about why prostate cancer deaths are rising (4). The rate has steadily increased since the early 2000s (coinciding with the introduction of multi-needle “systematic” biopsy of the whole gland), more so from 2010 onwards (after the Nuada trans-perineal “mapping” biopsy was introduced). Both procedures were each widely adopted, the latter receiving approval for routine use from the Interventional Procedures Advisory Committee in 2011. It was incorrect for screening enthusiasts to take the credit for falling breast cancer deaths when better treatment was the explanation (5). It would be equally wrong for urologists or prostate cancer charities to call for more screening, even with new modalities, without considering iatrogenesis from current opportunistic screening as a possible cause. The multi-needle trans-perineal biopsy continues as the recommended diagnostic procedure in the NICE Prostate Cancer Guideline 2019 (6), with no advice given about risks or possible precautions.

Seemingly safe surgical procedures or devices have later proven dangerous (7). It is peculiar that one surgical specialty confidently considers an increasingly extensive multi-needle biopsy for cancer to be safe in just one organ. Urologists do not appear to baulk when all five recently reported results of radical surgery for intra-capsular prostate tumour, as assessed at the time of biopsy, provided evidence of a high incidence of extra-capsular tumour extension, and positive surgical margins, at histology examination of the excised prostate glands (8, 9). Initial staging assessment must have been incorrect unless, or as well, multi-needle biopsy physically spreads tumour.

Thus men have not been warned that multi-needle biopsy techniques used for diagnosis and staging might cause extra-capsular tumour extension (10). Active surveillance with repeated interval biopsy is still offered for the management of early prostate cancer. Given the already recognised risk of biopsy-caused infection and the potential of enhanced local progression of malignancy, it is surely time to formally investigate: (a) the risk of overdiagnosis following initial PSA screening; (b) re-assessing the integrity of the capsular margin and extent of tumour tissue each time prostate biopsy is positive or repeated; (c) the discontinuation of prostate biopsy for diagnosis; and (d) whether it is safe and effective to rely instead on multi-parametric MRI alone to guide decision making as regards diagnostic accuracy (11).

In light of the delayed Cumberledge recommendations (7, 12) we draw attention to the complexity of regulation, especially uncertain post Brexit (13). No single institution or regulator is able to address persistent concerns when the pace of innovations resembles the Wild West Gold Rush. None of NICE, MHRA or NHS Board have been able to officially opine on the question of the safety of multi-needle biopsy (14). We call for an independent review into the widespread use of multi-needle prostate biopsy over the past 20 years.

References

1. Ilic D, Neuberger MM, Djulbegovic M, Dahm P. Screening for prostate cancer. Cochrane Database Syst Rev 2013(1):CD004876 https://doi.org/10.1002/14651858.CD004720.pub3

2. Early detection of prostate cancer with PSA testing and a digital rectal exam Harding Center for Risk Literacy. https://www.harding-center.mpg.de/en/fact-boxes/early-detection-of-cance...

3. Report of The Independent Review of Adult Screening Programmes in England. October 2019. Publication approved reference: 01089: Professor Sir Mike Richards. https://england.nhs.uk/p-content/uploads/2019/02/review-of-adult-screeni...

4. Improving Outcomes in Breast Cancer. Guidance on Cancer Services. NHS: National Institute for Clinical Excellence. ISBN: 1-84257-188-5. Published by the National Institute for Clinical Excellence August 2002. https://www.nice.org.uk/guidance/csg1/resources/improving-outcomes-in-br...

5. Spencer B. Prostate deaths hit record high of 12,000. In Daily Mail Online, 16 January 2020. https://mail.google.com/mail/u/0/?tab=wm&ogbl#inbox/FMfcgxwHMGLRZTqhttCt...

6. NICE Prostate cancer: diagnosis and management. NICE Guideline [NG131]. Published May 2019. https://www.nice.org.uk/guidance/ng131

7. The Independent Medicines and Medical Devices Review. https://www.immdsreview.org.uk/index.html

8. Stainsby GD. 10-year Outcomes in Localised Prostate Cancer. Letter to Editor [and see Authors reply]. N Engl J Med 2017;376: 178-181. January 12: 2017: https://www.nejm.org/doi/full/10:1056/NEJMc1614342
https://www.nejm.org/doi/full/10.1056/NEJMoa1606220?query=recirc_curated... 5.

9. Stainsby. GD. Safety of multi-needle prostate biopsy needs urgent investigation. The HealthWatch NewsLetter. Issue 108: p.3-5. Autumn 2018. https://www.healthwatch-uk.org/images/Newsletters/Number_108.pdf?idU=2

10. Stainsby GD, Bewley S. Patients’ roles and rights in research.
BMJ 2018;362:k3193 https://www.bmj.com/content/362/bmj.k3193/rr-10

11. Russell J. Assessment of prostate ductal adenocarcinoma on multi-parametric MRI. Surgical Research Report 2019–2020:120. Royal College of Surgeons of England. https://www.rcseng.ac.uk/news-and-events/news/archive/surgical-research-...

12. Healthwatch. Five demands to keep patients safe from medical device harms – but can the Independent Review put patients before profits? Press release 24th March 2020 https://www.healthwatch-uk.org/news.html

13. Stainsby GD (personal communication), 20 years correspondence [with distinguished Members of the Profession, NHS Authorities and Committees]

Competing interests: Declaration of interests: SB is chair of HealthWatch (a charity ‘for science and integrity in healthcare’). DS benefited from a post-biopsy MRI that demonstrated extracapsular tumour spread, thus changing the staging and treatment of his prostate cancer.

24 March 2020
Susan Bewley
Professor Emeritus Obstetrics & Women's Health
David Stainsby, Retired Orthopaedic Surgeon, Newcastle
King's College London
Dept of Women and Children's Health Kings College London