This paper is submitted as Supplementary Evidence to PIP Action Campaign’s written evidence of 21 July 2025 (Reference BIP0142) under the Health Impacts of Breast Implants and Other Cosmetic Procedures Inquiry.
“Outdated NHS and MHRA information continues to mislead diagnosis, delay treatment, and endanger lives. For women affected by PIP—whether implants remain, were replaced, or removed—and for the clinicians who rely on official advice, a decade of uncorrected statements denying harm has created confusion, complacency, and preventable suffering.”
This document calls for the:
1. Immediate revision of all NHS and MHRA information on fraudulently manufactured PIP implants, incorporating toxicological, oncological, and surgical realities ignored since 2012.
2. Immediate withdrawal of the 2012 Keogh Report.
3. Urgent correction of all public information, and recognition that the PIP scandal is not over—it remains an unacknowledged public-health crisis still unfolding in women’s bodies.
4. Full recall: all PIP implants must be removed—with full capsule excision and histological analysis.
• PIP-specific guidance is absent, with current NHS pages omitting explicit reference to affected women and leading to diagnostic delay.
• France notified two BIA-ALCL cases in December 2011; the first UK PIP fatality was reported in 2012.
• MHRA slides (Dec 2023) cite “1 report with a fatal outcome” while FOI data differ—these inconsistencies must be reconciled and published.
• “Definition drift” restricts counts to WHO-criteria cases, excluding suspected or incomplete diagnoses.
• Many PIP-exposed women suffer permanent injury: silicone migration, immune disturbance, chronic pain, systemic inflammation.
• Removal or replacement does not eliminate risk; residual capsules may still develop BIA-ALCL years later.
• Children exposed in utero or through breastfeeding remain unstudied
PIP exposure must be treated as a life-long medical risk condition requiring continued vigilance.
• NHS pages (archived 2021) still claim “no evidence of harm.”
• They omit PIP and fail to guide clinicians on testing peri-prosthetic fluid.
• The absence of updated clinician guidance perpetuates diagnostic delay and is scientifically indefensible
Updated guidance must:
• Address mammography risks—use ultrasound or MRI as preferred imaging.
• Require histology for every removed capsule and fluid sample (CD30/ALK testing).
• Ensure registry linkage for brand/batch-level transparency
The absence of PIP-specific advice represents a systemic failure of candour that endangers lives and violates patient rights.
• Women have been given no credible information about pregnancy, breastfeeding, diagnostics, or symptom monitoring.
• A single breast-milk sample test was used to justify claims of safety—an error that became policy.
• Clinicians were instructed that no toxic risk existed; this breaches the NHS Duty of Candour.
• Early reports of 'milky fluid' were dismissed as harmless water; independent studies (Beretta 2013, Bos 2023) identified silicone-serum micro-emulsions—evidence of silicone migration
By misrepresenting this as water, the UK minimised chemical injury and discouraged testing. A review of archived pathology samples is essential.
• Issue interim PIP specific clinician guidance on late seroma and capsular mass as potential BIA-ALCL.
• Publish corrected NHS patient information acknowledging PIP exposure.
• Restore a mandatory implant registry with brand/batch/outcome data.
• Release all MHRA adverse-event and mortality data for audit.
• Notify GPs that removal does not reset cancer risk; maintain lifetime vigilance.
• Audit discrepancies between MHRA slides, FOI replies, and coroners’ findings.
• NHS/MHRA webpages (last amended 2012) still state “no evidence of harm”—language that is now demonstrably false and unsafe
Revised guidance must include:
• Toxicological findings identifying D4/D5 siloxanes as reproductive/endocrine toxicants.
• International data confirming rupture and migration.
• Explicit recognition of BIA-ALCL risk in PIP-exposed women.
• Alerts covering fertility, breastfeeding, and foetal-development risks.
• Confirm whether post-2012 chemical analyses of PIP implants exist.
• Publish any withheld MHRA/DHSC correspondence on toxicity and migration.
• Ensure future testing is independent and consistent with the principle of “First Do No Harm.”
• Update NHS protocols for imaging, biopsy, and histology of suspected cases.
• Disseminate alerts to relevant clinical specialties describing known symptom clusters.
• Launch joint MHRA/NHS/Coroners audit to identify historic, unreported, and emerging BIA-ALCL cases.
• Re-examine the first UK fatality (2012) for compliance.
• Reinstate routine public reporting of implant-associated cancers.
• Correct NHS/MHRA public statements denying links between implants and illness or cancer.
• Update online materials and patient leaflets to reflect current evidence.
• Failure to act breaches statutory Duty of Candour under NHS and GMC codes.
France – Declared public-health crisis; funded explant programme; published brand-level data; lifelong follow-up.
Outcome: Women informed, monitored and treated with respect.
United Kingdom – Denied harm; refused universal NHS replacement; dissolved registry; issued no brand-specific alerts.
Outcome: Women disbelieved, unrecorded and abandoned.
No chemical testing – Unmeasured toxicity and chronic illness.
No registry – Lost traceability, no follow-up.
“No evidence of harm” messaging – Diagnostic delay and dismissed symptoms.
No capsule histology – Missed lymphoma and autoimmune diagnoses.
No breastfeeding or pregnancy guidance – Continued exposure to infants.
Reliance on Keogh 2012 – Policy frozen on false premise
Silence is not neutrality. It is complicity — and women have paid for it with their health, lives, and trust.
1. Direct the Secretary of State for Health and the MHRA to urgently revise all NHS/MHRA information and guidance on fraudulent PIP implants, explicitly naming BIA-ALCL, toxicity, and maternal risk.
2. Withdraw the 2012 Keogh Report as scientifically invalid.
3. Recognise PIP as an ongoing public-health crisis and establish a statutory Public Inquiry under the Inquiries Act 2005.
4. Issue a PIP-specific patient-safety alert to clinicians on late seroma and mandatory CD30/ALK testing.
5. Guarantee representation of PIP women as direct stakeholders in any review or policy process.
1. Update and publish corrected NHS/MHRA content.
2. Issue national safety notice to clinicians on BIA-ALCL and PIP history.
3. Re-establish mandatory registry with brand and chemical fields.
4. Release all brand-level adverse-event and mortality data for independent audit.
November 2025