Medicines & Medical Devices Safety Review
The Independent Medicines and Medical Devices Safety Review was a 29-month investigation that exposed a "system-wide failure" to listen to thousands of women and children harmed by pelvic mesh, Sodium Valproate, and Primodos.
The Independent Medicines and Medical Devices Safety (IMMDS) Review, published in July 2020 as the report First Do No Harm, represents a watershed moment in British healthcare. Chaired by Baroness Julia Cumberlege, the review was commissioned to investigate how the healthcare system responded to three specific medical interventions that caused life-altering harm to thousands of patients: pelvic mesh implants, the anti-epileptic drug Sodium Valproate, and the hormone pregnancy test Primodos.
The Findings: A System-Wide Failure
The review’s primary finding was a "system-wide failure" to protect patients. It uncovered a culture of dismissal, where clinicians and regulators ignored or "gaslit" patients—predominantly women—who reported chronic pain, disabilities, and developmental harm in their children. The report noted that the medical establishment often treated these concerns as psychological rather than physical, leading to decades of avoidable suffering.
The investigation identified several systemic flaws:
Lack of Informed Consent: Patients were frequently denied information about the risks of treatments or the existence of safer alternatives.
Regulatory Failure: The Medicines and Healthcare products Regulatory Agency (MHRA) was deemed to be too closely aligned with the industry it regulated, lacking the transparency and "patient-first" mindset necessary for safety.
Fragmented Data: There was no central registry to track medical device outcomes, meaning problems could go undetected for years.
Nine Strategic Recommendations
The report provided nine core recommendations to fix the "broken" system. These included a formal government apology, the appointment of an independent Patient Safety Commissioner, and the creation of a Redress Agency to provide financial support to those harmed outside of the adversarial court system. It also demanded a mandatory database for all medical device implants and the establishment of specialist centers to treat mesh complications and medicine-related developmental issues.
Legacy and Current Status
The impact of the review has been significant but remains incomplete. The government issued a full apology and appointed Dr. Henrietta Hughes as the first Patient Safety Commissioner in 2022. Several specialist mesh centres have opened, and progress is being made on the "Outcomes Registry."
However, a major point of friction remains: financial redress. While the government has implemented several administrative changes, it has largely rejected the call for a dedicated redress scheme for victims of Valproate and Primodos, leaving many families to feel that justice has not yet been fully served.
Key numbers at a glance
59
Recommendations
29
Months to complete
5
Cost in millions (if known)
Deaths (direct)
Recommendations
The IMMDS Review (Cumberlege Review) resulted in a report titled First Do No Harm, which proposed a tiered system of improvements: 9 Strategic Recommendations for broad systemic change and 50 Actions for Improvement for specific clinical and regulatory fixes.
The 9 Strategic Recommendations
The government issued a full response in July 2021, accepting some while controversially rejecting others.
# | Recommendation | Government Response |
1 | Fulsome Apology: An unreserved apology from the government to affected families. | Accepted. Issued by the Health Secretary on July 9, 2020. |
2 | Patient Safety Commissioner: A statutory, independent leader to champion patients. | Accepted. Dr. Henrietta Hughes was appointed to this role in 2022. |
3 | Redress Agency: A non-adversarial agency to resolve harm claims quickly. | Rejected. Government argued existing legal routes and "claims gateways" are sufficient. |
4 | Specific Redress Schemes: Dedicated funds for Valproate, Mesh, and Primodos victims. | Rejected. Government cited a preference for improving safety over retrospective payouts. |
5 | Specialist Centres: Regional centers for mesh and pregnancy-related medication harm. | Accepted. 9 mesh centers are now operational; Valproate centers are in development. |
6 | MHRA Overhaul: The regulator must put patients first and reform adverse event reporting. | Accepted. The MHRA is currently undergoing a "substantial transformation." |
7 | Central Database: A mandatory registry for all medical device implantations. | Accepted. Legislated via the Medicines and Medical Devices Act 2021. |
8 | Transparency of Interests: A public register of doctors' financial and clinical interests. | Accepted in Principle. Interests will be published locally at the employer level. |
9 | Implementation Taskforce: A body to oversee the delivery of all recommendations. | Partially Accepted. The government used an internal Patient Reference Group instead. |
Summary of the 50 Actions for Improvement
While the 9 strategic points hit the headlines, the 50 "Actions for Improvement" targeted the "nitty-gritty" of how healthcare is delivered. The government accepted or accepted in principle 46 of these 50 actions. They can be summarized into four key themes:
Clinical Practice & Consent: Better "Yellow Card" reporting by patients, mandatory shared decision-making tools, and ensuring patients are never told a risk is "theoretical" if there is evidence of harm.
Regulatory Reform: The MHRA must proactively search for safety signals rather than waiting for reports, and there must be better communication between the regulator and the public.
Data & Research: Strengthening the use of "real-world evidence" and ensuring that data from private providers is shared with the NHS to ensure no patient "falls through the cracks."
Conflict of Interest: Stricter rules for clinicians who receive funding from pharmaceutical or device companies, ensuring these links are visible to the patients they treat.
The most contentious part of the legacy remains the rejection of Recommendations 3 and 4. Many victims feel that without financial redress, the government has acknowledged their suffering but refused to help them manage the resulting costs of care.
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