Written evidence from Professor Carl Heneghan BM, BCh, MA, MRCGP, DPhil (Oxon) and Dr Tom Jefferson MD, MSc, MRCGP, FFPHM, DRCOG, DTM&H [BIP0005]
Professor Carl Heneghan BM, BCh, MA, MRCGP, DPhil (Oxon) Professor of Evidence-Based Medicine
Director of Programs in Evidence-Based Healthcare, Fellow of Kellogg College, University of Oxford & NHS Urgent Care GP
Dr Tom Jefferson MD, MSc, MRCGP, FFPHM, DRCOG, DTM&H
Formerly Edmund Parkes Professor of Preventive Medicine Senior Associate, Centre for Evidence-Based Medicine
& Senior Associate Tutor, Department for Continuing Education University of Oxford
A brief history of breast implants
1. In the 1890s, paraffin was injected into breasts to increase their size. But the paraffin leaked, and the technique was abandoned. In the 20s and 30s, surgeons tried transferring fat, also not a good idea. And in the 50s, cartilage, wood, and even glass balls were used – the side effects were disastrous. In 1962, Timmie Jean Lindsey, in Houston, Texas, was the world’s first to undergo breast augmentation surgery using silicone implants.
2. In the 1980s, concerns emerged that silicone breast implants increased the risk of cancer, connective-tissue diseases and various autoimmune diseases. The mainstream media picked up on these issues in 1988, when an American consumer interest group reported silicone gel implants could cause cancer in rats. 1 By then, more than two million American women had received silicone implants. Although the US FDA concluded the results in rats were irrelevant to women, the anxieties caused by the media frenzy led thirty thousand US women to have their implants removed.
Evolution of silicone implants
1. Silicone is a mixture of compounds whose properties can vary so that they can become more or less stiffer and stickier. Changes aim to create implants that maintain their shape over the long term. For example, changes to the surface aim to prevent tightening, squeezing and rupture.
First-generation silicone gel-filled implants used a thick, smooth silicone encased in an envelope made with seams. These first attempts used a polyurethane-coated foam, which degraded and
1 Silicone Implants Tied To Cancer in Test Rats. Share full article. By Warren E. Leary, Special To the New York Times. Nov. 10, 1988. https://www.nytimes.com/1988/11/10/us/silicone-implants-tied-to-cancer-in-test-rats.html
released 2-toluene diamine, a known carcinogen in animals. The FDA asked the manufacturer to supply information on safety testing. But before this could happen, the manufacturer removed the implants from the market, making the need for safety information unnecessary.
3. In 1992, The Lancet reported that patients with silicone gel breast implants and antinuclear antibodies (ANA) were more likely to experience specific health issues. 2 Antibodies are a normal part of the body's immune system, helping to fight infections. They do this by recognising foreign proteins. Sometimes antibodies make mistakes and identify the body's proteins as foreign. We call these autoantibodies. The presence of autoantibodies aids in the diagnosis of systemic autoimmune disorders that affect multiple tissues and organs throughout the body.
The study assessed the features in 24 patients, all of whom, except one, had received silicone gel breast implants. ANA specificities were identified using indirect immunofluorescence, immunodiffusion, Western blot analysis, and immunoprecipitation of radiolabeled intracellular proteins. Of 11 patients who had symptoms and signs that met criteria for defined autoimmune diseases, 7 had scleroderma or subsets of this disorder, and the others had systemic lupus erythematosus, rheumatoid arthritis, or overlapping autoimmune diseases. High ANA titres were present in 10 of these 11 patients, and the ANA specificities were similar to those found in the idiopathic forms of the corresponding autoimmune diseases. Trauma, with resultant rupture of implants, accelerated the onset of symptoms.
Increasing concerns
4. In 1988, the FDA’s Breast Implant Advisory Panel classified silicone gel breast implants as the highest-risk device - Class III.3
5. THE FDA Defines Class III devices as ‘those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.’ 4
6. A Class III FDA classification means that manufacturers had to provide clinical trial evidence proving the implants were safe and effective through the Premarket Approval (PMA) route. Confusingly, however, implants were still allowed to be reviewed through the less robust 510(k) process, as per US law.
The FDA issued a final deadline of 1991 for manufacturers to submit evidence.5 Several manufacturers used this loophole to gain market access through the less stringent approval process.
Companies that had a pre-amendment or 510(k)-cleared silicone gel-filled breast implants and submitted their PMA within 90 days of the April 1991 regulation, were allowed to keep their device on the market until a final decision or action was made by April 1992.
Since April 1992, a silicone gel-filled breast implant must be PMA-approved to be sold on the market.
2 Antinuclear autoantibodies in women with silicone breast implants. Lancet. 1992 Nov 28;340(8831):1304-7. doi: 10.1016/0140- 6736(92)92491-w.
3 Review: the breast implant fiasco. California Law Rev. 1999;87(2):457-510.
4US FDA. Premarket Approval (PMA) https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing- correct-submission/premarket-approval-pma
5 US FDA. Breast Implants. https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
7. The evidence submitted by manufacturers in 1991 contained insufficient safety data to meet the approval requirements of PMA.6
8. The FDA believed that there was a public health need to have breast implants available for reconstruction and revision patients. Therefore, companies that had not withdrawn their PMAs before the April 1992 decision were allowed to submit an adjunct study protocol for FDA approval to address the public health need. Only Mentor Corporation and Inamed Corporation received approvals for their adjunct studies. Adjunct studies are limited to patients undergoing reconstruction and revision. Women who want silicone gel-filled implants for augmentation (cosmetic reasons) cannot be enrolled in an adjunct study.
9. The FDA’s advisory panel met again and unanimously recommended the implants stay on the market pending further study results.
10. In December 1991, a California jury awarded Marianne Hopkins $7.3 million. Having undergone a double mastectomy, she developed mixed connective tissue disease that was put down to her silicone implants. The case documents showed that the manufacturer, Dow Corning, was aware that silicone was leaking out of their implants but did nothing to provide long-term safety data. These second-generation implants aimed to reduce the incidence of capsular contracture by using thinner and seamless shells. However, they were prone to leakage—although under seal, the court documents were leaked to the media.
11. While they contained no new evidence of safety concerns, they had a dramatic impact on the FDA’s commissioner, Dr. David Kessler. On January 6th, 1992, he called for a voluntary delay in silicone implants because of the possible link between them and autoimmune diseases. He announced a 45-day voluntary moratorium and restricted the use of implants to clinical trials.
Kessler wrote, 'Thirty years after silicone breast implants appeared on the market, the list of unanswered questions about their safety remains long.’ There was a lack of evidence on rupture rates, limited evaluations of the chemicals that leak into the body when implants rupture, and deficiencies in the evidence regarding the lifespan of implants. Kessler also stated that had the FDA failed to intervene, ‘the uncontrolled and widespread availability of breast implants would probably have continued for another 30 years.’ 7
12. While the US was restricting the use of breast implants due to safety concerns, the UK’s Department of Health’s advisory group came to the opposite conclusion - no link existed between silicone breast implants and connective tissue disease. 8
13. Concerns about a possible link between silicone gel implants and connective tissue diseases prompted the Medical Devices Directorate (MDD) of the Department of Health to review available data for an Expert Advisory Group. Animal studies indicate silicones are unlikely to trigger antibody responses or affect infection resistance. While silicones have minimal effects in the presence of adjuvants, they can also act as adjuvants.
Scleroderma is the primary connective tissue disease associated with breast implants. Although one study found a higher prevalence of this condition among implant patients, there was no
6 Center for Devices, Radiological Health. Breast Implants - FDA Breast Implant Consumer Handbook – 2004 - TIMELINE OF BREAST IMPLANT ACTIVITIES.
7 Kessler DA. The basis of the FDA's decision on breast implants. N Engl J Med. 1992 Jun 18;326(25):1713-5. doi: 10.1056/NEJM199206183262525.
8 Silicone breast implants: an oncologic perspective. Oncology (Williston Park).1998 Oct;12(10):1427-33; discussion 1434,1439-43.
conclusive evidence that the incidence of scleroderma in women with implants was higher than in the general population.9
14. Regulators were at odds with each other and confused about what to do. France, for instance, banned the implants only to overturn the ban within three years. The UK’s Chief Medical Officer set up an Independent Review Group (IRG) in response to concerns raised by the UK’s Minister for Health, Baroness Jay. She was concerned that many women with breast implants complained of severe medical problems.
15. Evidence accumulated that breast implants were safer than first thought. The British Medical Devices Agency (MDA) analysed three UK reviews and concluded the risks from silicone gel breast implants were no more significant than for any other type of implant.10
16. The MDA has responded comprehensively to concerns over the safety of breast implants by:
— from 1988, assessing the risk of cancer arising from silicone gel breast implants. The risk was considered remote, and these implants remain available.
— From 1991, assessing the risk of cancer arising from the breakdown of the polyurethane coating applied to some implants. MDA issued two Advisory Notices informing clinicians that these implants should not be used.
— From 1991, assessing evidence for a link between silicone gel breast implants and autoimmune disease or other associated health problems. These issues were addressed in a series of major scientific reviews, two by MDA and an Independent Expert Advisory Group, in 1992 and 1994, and a third by an Independent Review Group (IRG). The IRG concluded, in 1998, that risks from silicone gel breast implants are no greater than for any other type of implant.
— From 1998, assessing the safety of lipid-filled breast implants. These implants were withdrawn from use in the UK in 1999, and MDA advised in 2000 that women should consider having them removed.
— From 1999, assessing the safety of two types of hydrogel-filled breast implants. These implants were withdrawn from use in the UK in 2000.
17. In 1999, the U.S. Institute of Medicine reviewed saline-filled and silicone-gel-filled breast implants. Their report concluded there was insufficient evidence to establish whether implants cause autoimmune diseases, and that rupture, pain, capsular contracture, disfigurement, and severe infection were the main safety concerns with breast implants. 11
18. In 2000, a meta-analysis of 20 studies reported no associations between silicone breast implants and rheumatoid arthritis and a range of autoimmune diseases, including systemic lupus erythematosus, scleroderma or systemic sclerosis. 12
19. In March of the same year, the FDA Advisory Panel recommended approval of two saline-filled breast implants. By 2006, silicone gel-filled implants were also FDA approved, effectively ending a 14-year ban on their approval. 13
20. Fourth—and fifth-generation implants evolved due to more stringent PMA requirements, additional testing criteria, and improved quality control. The FDA’s removal of the ban had a
9 Breast implants: is there an association with connective tissue disease? Health Trends. 1994;26(1):25-6.
10 The Committee Office, House of Commons. House of Commons - Health - Minutes of Evidence. The Stationery Office Ltd. 2001.https://publications.parliament.uk/pa/cm200001/cmselect/cmhealth/308/1032213.htm
11 Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants. Safety of Silicone Breast Implants. Bondurant S, Ernster V, Herdman R, editors. Washington (DC): National Academies Press (US); 1999.
12 Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000 Mar 16;342(11):781-90. doi: 10.1056/NEJM200003163421105.
13 US FDA. Premarket Approval (PMA) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P020056
dramatic effect on silicone implant use, which increased from 35% of the US market share to more than 77% by 2014. 14
21. For approval, the FDA required at least three years of data for silicone gel breast implants and two years for standard saline-filled breast implants. In November 2006, the FDA approved Allergan’s Natrelle Silicone Gel-Filled Breast Implants and Mentor’s MemoryGel Silicone Gel- Filled Breast Implants.
22. Once on the market, the FDA required 10-year, multi-centre, prospective follow-up studies in women who received silicone gel-filled breast implants after FDA approval in 2006. Each study includes a control group of women who received saline-filled breast implants during the same period, and the studies should follow 40,000 women. 15
23. Allergan launched its extensive study in February 2007 and completed enrolment in March 2010, involving 41,342 recipients of silicone gel-filled breast implants and 15,646 recipients of saline breast implants. The results are from Allergan's 2010 annual report and include participants with a 2-year follow-up.
Similarly, Mentor's Large Study began in February 2007 and concluded in July 2009, involving 41,975 participants with silicone gel-filled breast implants and 1,030 participants with saline implants. The findings are from Mentor's 2010 annual report, covering those with a 3-year follow-up.
24. Allergan reported a 2-year cumulative incidence of local complications and other adverse outcomes related to the implant as follows:
25.
a. Reoperation. 6.5% for silicone gel-filled breast implant participants and 4.5% for saline breast implant participants.
b. Rupture. 0.5% for silicone gel-filled breast implant participants and 2.5% for saline breast implant participants (saline implant deflation).
c. Capsular Contracture (Grades III/IV). 5.0% for silicone gel-filled breast implant participants and 2.8% for saline breast implant participants.
d. Implant removal with or without replacement. 3.4% for silicone gel-filled breast implant participants and 2.4% for saline breast implant participants.
26. Mentor reported the 3-year cumulative incidence of local complications and other adverse outcomes for silicone gel-filled breast implant recipients as follows:
a. Reoperation. 10.8% for augmentation, 14.6% for revision-augmentation, 20.4% for reconstruction, 17.7% for revision-reconstruction.
b. Rupture. 0.2% for augmentation, 1.0% for revision-augmentation, 0.4% for reconstruction, 0.7% for revision-reconstruction.
c. Capsular Contracture (Grades III/IV). 5.3% for augmentation, 11.8% for revision- augmentation, 9.1% for reconstruction, 10.0% for revision/reconstruction.
d. Implant removal with or without replacement. 5.0% for augmentation, 7.7% for revision- augmentation, 13.5% for reconstruction, 11.7% for revision-reconstruction.
27. The FDA also recommended magnetic resonance scanning every three years after the first implant and then every two years.
14 Working Toward a Solution: The Unanswered Questions About Silicone Gel Breast Implants. Ann Intern Med. 2016 Feb 2;164(3):201-2. doi: 10.7326/M15-2307. Epub 2015 Nov 10.
15 Update on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary. https://www.fda.gov/medical- devices/breast-implants/update-safety-silicone-gel-filled-breast-implants-2011-executive-summary
The FDA cautioned, “Breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman's breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI (magnetic resonance imaging) examinations over her lifetime to determine if silent rupture has occurred.”
The cost of this additional screening often exceeds the price of the implant surgery, and since the added cost is not covered by health insurance, it did not happen.16
28. In September 2020, the FDA issued final guidance containing recommendations for the content and format of certain labelling information for saline and silicone gel-filled breast implants. The FDA issued this guidance to help ensure that patients receive and understand the benefits and risks of these devices. The recommendations were made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of these devices. 17
29. On October 27, 2021, the FDA took several actions to strengthen breast implant risk communication and help those considering breast implants make informed decisions. These actions include orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. 18
30. Much of the knowledge about silicone breast implants is derived from manufacturer studies tracking long-term clinical outcomes. Adverse events and device performance, such as capsular contracture, implant malposition, and rupture rates, are typically easier to monitor because these issues often arise early or require reoperation. Women with general health issues, like autoimmune diseases, frequently do not report concerns unless they are related to their implants. Additionally, studying systemic health outcomes is complicated by the rarity of certain diseases, making in-depth analyses difficult. The lack of information on confounding factors and patient drop-off during follow-ups also hinders the assessment of meaningful outcomes.
PIP Implant scandal:
31. Although evidence for the safety of implants was accumulating, what happened with PIP implants highlighted significant loopholes in the manufacturing process that put patients at risk.
32. In 1991, Jean-Claude Mas, a former butcher turned medical sales representative for Bristol- Myers Squibb, and Henri Arion, a plastic surgeon who introduced breast implants to France in the 60s, launched the Poly Implant Prothese (PIP), which produced over two million sets of silicone breast implants.
33. PIP received 510(k) approval from the US for their saline-filled breast implant in 1996. 19 The FDA allowed the saline implant to be approved without clinical trial evidence because saline implants had been available before 1976 and were therefore assumed safe unless proven otherwise.
16 FDA approves silicone breast implants 14 years after their withdrawal BMJ 2006; 333 :1139 doi:10.1136/bmj.39048.332650.DB
17 Breast Implants - Certain Labeling Recommendations to Improve Patient Communication. Guidance for Industry and Food and Drug Administration Staff September 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast- implants-certain-labeling-recommendations-improve-patient-communication
18 FDA Strengthens Breast Implant Safety Requirements. https://www.fda.gov/medical-devices/implants-and-prosthetics/breast- implants
19 Heneghan C. The saga of Poly Implant Prosthese breast implants. BMJ 2012;344:e306.
34. As a consequence of the FDA’s requirement for all implant (saline and silicone) manufacturers to submit evidence for PMA approval before marketing their products, PIP's application to the FDA was rejected. The clinical trial data relating to the PIP implant that the company submitted to the FDA for approval did not include enough patients followed up for long enough to evaluate the implant’s safety. 20
35. In May 2000, the FDA began inspecting PIP’s manufacturing site in La Seyne-sur-Mer, France. They found numerous manufacturing deficiencies and at least 11 deviations from good manufacturing practices with the production of the PIP’s saline implants. As a result, PIP stopped selling its saline and silicone implants in the US. Despite the FDA posting a warning letter on its website stating that PIP failed to investigate problems with the deflation of the saline implants and failed to report more than 120 French complaints to the FDA, European regulators took no action. The FDA sent a copy of their letter to Mas but not to the regulators, and as expected, Mas covered up.
36. The loss of revenues meant that costs were cut drastically. PIP implants were manufactured from an unapproved industrial-grade silicone, cutting the implant's cost by nearly 90% (estimates suggest they saved $1.6 million in one year). 21
37. The protective outer skin of the implant was replaced with lower-grade silicone. These changes occurred sometime in 2001. Implants began rupturing at a much higher rate: more than double the industry average. In 2010, the French medical safety agency recalled the implants and advised 30,000 women to have their implants removed. In March 2010, inspectors found six discarded plastic containers of Silopren, designed for industrial use, which contained nearly 9 tonnes of silicone. Police were informed, and within two weeks of the inspection, the company was closed and went into liquidation. PIP sold more than 300,000 silicone gel implants in 65 countries.
38. Regulatory gaps in the European approval system helped PIP keep its products on the market. There was no requirement for unannounced checks of the implant's contents or chemical composition tests once it was approved. Annual audits of the manufacturers by the Notified Body, TUV Rheinland, did not perform any on-site tests. The Notified Body was cleared of wrongdoing by the French high courts, who reported that "TUV Rheinland could not have detected the fraud committed by PIP with the tools granted to certification organisations under current regulations."
39. The European regulatory system is often criticised for its lax approach to safety. This was demonstrated by a 2016 Dutch study on Silicone breast implants, commissioned by the Dutch Health and Youth Care Inspectorate, which found deficits in the laboratory tests conducted by manufacturers. The study evaluated ten technical files of breast implant manufacturers and found that while all performed mechanical implant testing, there were no problems with biocompatibility and cytotoxicity testing (some good news). 22 However, there were missing tests for irritation, sensitisation, and implantation tests.
40. Sensitisation tests are designed to see if the implant material initiates a sensitising effect or an allergic reaction in patients over an extended period of exposure. But because they often, if not always, involve small animals (e.g., mice), it becomes impossible to evaluate sensitivity.
20 Insight: FDA warned PIP on breast implant safety in 2000. U.S. 2011. https://www.reuters.com/article/business/healthcare- pharmaceuticals/fda-warned-pip-on-breast-implant-safety-in-2000-idUSTRE7BQ03N/
21 Sage A. Special Report: The French breast implant scandal. U.S. https://www.reuters.com/article/business/healthcare- pharmaceuticals/fda-warned-pip-on-breast-implant-safety-in-2000-idUSTRE7BQ03N/
22 Silicone breast implants in the Netherlands : A market surveillance study. https://www.rivm.nl/publicaties/silicone-breast- implants-in-netherlands-a-market-surveillance-study
Furthermore, the substantiation of equivalence between breast implants and other implants was not always addressed. The requirement to have “criteria for the necessity of taking action” during the post-marketing surveillance period and the level of detail required for safety and performance claims were not adequately reported. Complete and correct technical files, which the reports indicate are not done, are essential to ensure patient safety of devices within the European Union.
UK Response to the PIP implant scandal
41. The UK’s Department of Health responded to the PIP implant scandal in 2012 by reporting that the implants were safe. 23 An expert group on breast implants, led by Professor Sir Bruce Keogh, concluded that the advice given by the MHRA still stands. The group concluded “that the advice given by the MHRA still stands and that there is not enough evidence to recommend routine explantation of these breast implants. The group also agrees there is no link with cancer.”
42. The group said there was insufficient evidence to determine the safety problems. Rupture rates in France were 5%, whereas those in the UK, reported by the Medicines and Healthcare products Regulatory Agency, were 1%. [14]
43. The report stated that the NHS would support the removal of PIP implants if, after this consultation, the patient still has concerns and, with her doctor, she decides that it is right to do so. The NHS will replace the implants if they performed the original operation. The group expected the private sector to do the same for their patients.
44. The NHS offer was: 24
● All women who have received an implant from the NHS will be contacted to inform them that they have a PIP implant and to provide relevant information and advice. If NHS patients seek information about the make of their implant in the meantime, it will be provided free of charge.
● Women who wish to can seek a consultation with their GP or the surgical team that carried out the original implant to get clinical advice on the best way forward.
● If the woman chooses, this could include an imaging examination to see if there is any evidence that the implant has ruptured.
● The NHS will support the removal of PIP implants if, informed by an assessment of clinical need, risk, or the impact of unresolved concerns, a woman, with her doctor, decides that it is the right thing to do.
● The NHS will replace the implants if they performed the original operation.
45. The UK’s Chief Medical Officer, Dame Sally Davies, said, "Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned, they should speak to their surgeon". Removing the implant "carries risks in itself," [22]. However, Andrew Lansley, the Health Secretary, ordered another review when UK rupture rates were reported as high as 8% in the media.
46. On 21 December 2012, the Department of Health published an update one year on since the PIP breast implant scare: Update on how thousands of women have turned to the NHS for help. 24
Almost 8,000 women, who had their implants put in privately, have turned to the NHS for help.
23 Department of Health statement on breast implants and response to expert group report. https://www.gov.uk/government/news/department-of-health-statement-on-breast-implants-and-response-to-expert-group-report 24 One year on since PiP breast implant scare. https://www.gov.uk/government/news/one-year-on-since-pip-breast-implant-scare
The latest figures, published last week, show that, up to 30th November:
● A total of 7,917 referrals have been received from women who had their implants put in privately.
● Of these, 5,255 scans have now been completed.
● 633 have decided to have their implants removed on the NHS - 418 operations have been done; and
● 4,328 women required no further help from the NHS at this time.
47. The final report of Sir Bruce Keogh’s expert group was published on 18 June 2012. 25 The report concluded that: Extensive testing of PIP gel material has shown no long-term health risks; it is neither toxic nor carcinogenic. However, PIP implants have a higher rupture rate—around 6 to 12% after five years and 15 to 30% after ten years —compared to 10 to 14% for other brands. PIP implants contain higher levels of siloxanes, compounds similar to silicone found in many consumer products. While these do not pose a health risk, ruptures can cause local reactions in some women, such as tenderness or swollen lymph glands, without leading to significant health issues.
48. In 2023, the PIP Breast Implant scandal was debated in the House of Commons. This was the first ever parliamentary debate on a health scandal that is affecting at least 47,000 women across this country in one way or another. The Right Honourable Fleur Anderson, MP, stated: “In replying to my written questions on concerns about PIP implants last November, the Minister cited two reports from the MHRA in 2010 and 2012, which seemed to be the basis for deciding that there was not a risk and putting that guidance on the website. However, so much more evidence has come to light since then. Does she have a view on the new evidence and why that has not been taken into account? Evidence buried away on the website contradicts the view that people with PIP breast implants do not need to worry. The risks are clear and well evidenced, and women should be told the truth.”
49. The current scale of the evidence considering breast implants requires review. A Search of PubMed reports that 329 systematic reviews have been indexed, 26 with 313 (95%) indexed since 2012.
50. In 2006, the New York Times reported that “These devices are prone to rupture, contract or cause pain and inflammation in the breast as time goes on. One study found that 69% of the recipients experienced a rupture, and almost a quarter of the women who received one manufacturer's implant for cosmetic reasons had to have it removed within the first four years.”
51. An extensive population-based study done in 2018 in Israel showed an association between silicone-based implants and autoimmune and rheumatic disorders, highlighting the need for ongoing vigilance. The study matched 24,651 women with breast implants, with 98,604 free of implants. Adjusting for age, socioeconomic status, smoking status and breast cancer history as potential confounders, they found women with implants had a 45% greater chance of being diagnosed with at least one autoimmune or rheumatic disorder. 27
52. Earlier research regarded silicone as a biologically inert material; however, recent research has questioned this hypothesis. Silicone has been shown to induce various immunological effects. While rupture leads to the release of silicone into the body, a process known as "gel bleed"
25 Poly Implant Prothèse (PIP) breast implants: final report
The final report of the expert group chaired by Sir Bruce Keogh, NHS Medical Director. https://www.gov.uk/government/publications/poly-implant-prothese-pip-breast-implants-final-report-of-the-expert-group
26 PubMed search link for systematic review of breast implants https://pubmed.ncbi.nlm.nih.gov/?term=breast+implant&filter=pubt.systematicreview&sort=date&size=100
27 Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) in 2023. Autoimmun Rev. 2023 May;22(5):103287. doi: 10.1016/j.autrev.2023.103287. Epub 2023 Feb 3.
occurs when microparticles of silicone leak from intact implants into the body. Silicone has been found in blood vessels, multiple tissues, and brain samples at autopsy. Gel bleed occurs because the implant shell is a semipermeable membrane that allows the silicone to bleed naturally. 28
53. A 2016 systematic review examined long-term health outcomes in women with silicone gel breast implants, including 32 studies published in 58 articles. 29 The findings remain inconclusive regarding any long-term health association with these implants. Most outcomes were supported by only one adequately adjusted study, typically showing no significant links. There were some possible associations, such as a decreased risk of primary breast and endometrial cancers and an increased risk of lung cancer, rheumatoid arthritis, Sjögren's syndrome, and Raynaud's syndrome. Overall, evidence specific to silicone gel implants was limited, and studies often did not adequately adjust for potential confounders. The authors concluded that there is a need for more extensive and better-quality studies.
54. The controversy over the association between silicone implants and adverse outcomes has been ongoing for 30 years and seems likely to continue.
55. The growing medical tourism industry worsens outcomes. For example, a systematic review of 17 observational studies of cosmetic tourism for breast augmentation found reports of sepsis, irreversible hypoxic brain injury, and death in the studies.30
56. The global cosmetic implants market is expected to surpass $20 billion by 2030. Breast implants are likely to account for a $3 billion share of this market. Unfortunately, the absence of high- quality evidence, regulatory dissonance, and the lack of registries until recently mean we will see new harms and safety messages.
Risk of Anaplastic Large Cell Lymphoma (ALCL)
57. Anaplastic large cell lymphoma (ALCL) is a rare type of cancer, with an incidence ranging from 1 in 50,000 to 1 in 300,000, that affects the white blood cells of the immune system.
58. A 2008 study analysing women with breast lymphoma in the Netherlands between 1990 and 2006 found eleven women had breast-induced ALCL. All eleven had received breast implants for cosmetic reasons. 31
59. In January 2011, US Food and Drug Administration (FDA) published a safety communication entitled ‘FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants’ In a review by FDA of scientific literature published from January 1997 to May 2010, they identified 34 cases of ALCL in women with breast implants worldwide. FDA’s adverse event reporting system also contained 17 reports of ALCL in women with breast implants. 32
28 Gel Bleed and Rupture of Silicone Breast Implants Investigated by Light-, Electron Microscopy and Energy Dispersive X-ray Analysis of Internal Organs and Nervous Tissue. https://clinmedjournals.org/articles/cmrcr/clinical-medical-reviews-and-case- reports-cmrcr-3-087.php?jid=cmrcr
29 Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016 Feb 2;164(3):164-75. doi: 10.7326/M15-1169. Epub 2015 Nov 10.
30 Cosmetic tourism for breast augmentation: a systematic review. ANZ J Surg. 2018 Sep;88(9):842-847. doi: 10.1111/ans.14326. Epub 2017 Dec 3
31 Anaplastic large-cell lymphoma in women with breast implants. JAMA. 2008 Nov 5;300(17):2030-5. doi: 10.1001/jama.2008.585. PMID: 18984890.
32 Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell- lymphoma
60. In 2011, the UK's MHRA initiated a medical device alert after reports of 14 cases of anaplastic large cell lymphoma (ALCL) in women who had breast implants or who had them removed. (MDA/2014/017). 33
61. In 2014, MDA/2014/027 reported 130 cases had been reported worldwide of patients with all types of breast implants who had developed ALCL.
62. In 2016, the World Health Organisation designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) a T-cell lymphoma that can develop following breast implants. 34
63. As of January 2017, a systematic review had found 95 reported cases of ALCL in the literature; the first documented case was reported in August 1997. The mean time to detection was 10 years after the implant was placed. Although ALCL is rare, its incidence is on the rise. In 2017, 55 cases were reported to the FDA, bringing the total to 414, with nine recorded deaths. Cancer has no preference for saline or silicone implants, but affected patients did receive an implant with a textured surface. 35
64. In August 2022, the FDA received 1,130 reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and 953 related to Allergan implants. The FDA issued a further safety warning in September of the same year after receiving 19 reports of squamous cell carcinoma that were distinct from BIA-ALCL. The agency also knew of nearly 30 cases of various lymphomas in the capsule around the implant. 36
65. As of 31 December 2023, we had received 81 reports of confirmed BIA-ALCL where the surgery occurred in the UK and six reports where the surgery occurred outside of the UK. “clinicians have a legal obligation to discuss the potential risk of BIA-ALCL when seeking informed consent of new patients, and with any patient returning for review of their breast implants.” 37
66. The current estimated incidence of BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 16,500 implants sold. Confirmed reports from 2024 are still ongoing, according to recent updates. 35
67. As of June 30, 2024, THE US FDA reports a summary of the 64 US. and worldwide deaths reported in MDRs and literature reported as MDRs since the FDA first identified a possible association between breast implants and the development of ALCL in 2011. 38
68. The FDA recommends explicitly that all confirmed cases be reported to the PROFILE registry. 39
33 Breast implants - report cases of anaplastic large cell lymphoma (ALCL) https://www.gov.uk/drug-device-alerts/medical-device- alert-breast-implants-report-cases-of-anaplastic-large-cell-lymphoma-alcl
34 The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
35 Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg. 2015 Mar;135(3):695-705. doi: 10.1097/PRS.0000000000001033.
36 UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around- breast-implants-fda-safety-communication
37 Guidance: Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl#full-publication-update-history
38 Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma https://www.fda.gov/medical- devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
39 PROFILE Registry https://www.thepsf.org/clinical-data-registries/profile
69. The current lifetime risk of BIA-ALCL is estimated to be 1:2,207-1:86,029 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. 40
70. The overall survival rate for patients diagnosed with BIA-ALCL is 89% at 5 years. This rate is significantly higher for patients with Stage I disease who undergo complete capsulectomy and implant removal. 41
The UK Breast Implant Register
71. In 1993, the UK was supposed to set up a National Breast Implant Registry. ALL WOMEN who have had operations to enlarge or replace breasts are to be traced and placed on a national register, the Department of Health announced. 42 Doctors would also be asked to log the approximately 100,000 patients who had already undergone operations. The Department of Health said the move was precautionary. 'The register is about reassuring patients that we know where they are, should there be any problems in the future, rather than saying there is a problem which needs addressing now.'
72. House of Commons Science and Technology Committee. Regulation of medical implants in the European Union and the United Kingdom. Fifth Report of Session 2012–13 reported that ‘The National Breast Implant Registry between 1993 and 2006 failed because “the completeness of registration was totally inadequate, and, secondly, the willingness of patients [...] to give follow- up information was far too low to allow conclusions to be drawn. 43
73. NHS Digital launched the Breast and Cosmetic Implant Registry in 2016, 29 years after it was first promised. 44 The DHSC directed NHS Digital (now known as NHS England) to implement the registry work in response to recommendation 21 of the Keogh Review of the Regulation of Cosmetic Interventions.
74. Access to the registry is now via the Outcome Registries Platform. 43
75. The latest data, covering the period from January to December 2023, was updated in October 2024. The Breast and Cosmetic Implant Registry Dashboard has been unavailable since June 25, 2024, due to a technical issue (PDF supplied as Appendix 1).
40 American Society of Plastic Surgeons. https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary
41 Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol. 2016 Jan 10;34(2):160-8. doi: 10.1200/JCO.2015.63.3412.
42 Breast implant women to be placed on register: Health department says. The Independent. 1993.http://www.independent.co.uk/news/uk/breast-implant-women-to-be-placed-on-register-health-department-says-record-of- surgery-is-only-a-1492926.html
43 House of Commons Science and Technology Committee. Regulation of medical implants in the EU and UK. Fifth Report of Session 2012–13
https://publications.parliament.uk/pa/cm201213/cmselect/cmsctech/163/163.pdf
44 NHS Digital. Breast and Cosmetic Implant Registry https://digital.nhs.uk/data-and-information/clinical-audits-and- registries/breast-and-cosmetic-implant-registry
76. In 2023, 18,367 patients underwent 18,836 operations at 335 organisations (NHS and independent providers).
77. The breast and cosmetic implant registry already records the details of any individual who has breast implant surgery so that they can be traced in the event of a safety issue relating to a specific type of implant. The registry also collects data on the outcomes of patients affected, which it is working on publishing but has not yet done so.
78. The national joint registry publishes interventions and outcomes annually. It is unclear why the breast implants registry has not followed a similar approach to transparency, which would facilitate patient safety and trust in the system. In a response to Lucy Johnston, Health and Social Affairs Editor, Sunday Express, NHSE responded that they are ‘currently assessing whether this data can be published in the future as part of the Outcome Registries Programme.’
79. House of Commons Science and Technology Committee. Regulation of medical implants in the European Union and the United Kingdom. Fifth Report of Session 2012–13 reported that Sir Kent Woods stated that “the transparency that now exists around the outcomes of joint replacement surgery through the National Joint Registry is a model of what might be achieved in other areas, were there to be better follow-up data presented more coherently and consistently”.
80. It is unclear when the registry started collecting outcome data. But it takes roughly ten years for the problems of BIA-ALCL to emerge, so we may not see data on harms in the registry until at least 2026.
Device regulation
81. Medical appliance CE marking is now regulated by the Medical Device Regulation (MDR) 2017. MDR was brought in to address some of the system's crucial shortcomings.
82. MDR came into force on 26 May 2021, with a 4-year transition period. At the end of this period, all medical devices, both existing and new, on the market will have to be MDR-compliant. Transition rules are complicated, but by May 26, 2024, all new devices entering the market must be MDR compliant.
Class of devices
83. Phasing depends on the device's class, which is proposed by the manufacturer, taking into account the device's intended purpose (indication) and its inherent risks. 45
Examples per Annexe VIII to the MDR:
● Class I, non-invasive devices, e.g. a sticking plaster or a simple surgical mask. If reusable after sterilisation, the Class is Is.
● Class IIa, non-invasive devices, for example, powered wheelchairs, pregnancy testing kits, or medicated plasters.
● Class IIb non-invasive devices are intended to be used principally for regenerative procedures of injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent.
The difference between the previous classes ranges from low to medium and from medium to high risk. Class III is an active implantable device, such as a pacemaker, carrying the highest risk.
Notably, devices that carry medication, such as drug-eluting stents, are classified as pharmaceuticals and do not fall under the MDR. Classes are also important as they dictate the degree of involvement of regulators. Class I do not involve regulators (because they are seen as less risky), the others do to a lesser or greater extent. To obtain a CE marking for Class I appliances, self-certification is sufficient, as the manufacturer is required to issue the EU declaration of conformity and prepare the technical documentation for these devices. 45
The Assessment
84. In the EU device world, regulators “designate” (we would use the term delegate) the assessment of conformity to Notified Bodies (NBs) before being placed on the market. According to the EU database Nando (New Approach Notified and Designated Organisations Information System), there are currently 55 Notified Bodies (NBs) that can certify medical devices. Each has an identifier and a name.
85. THE UK has nine approved Notified Bodies known as approved bodies for medical devices.46
45 European Commission. Medical device https://webgate.ec.europa.eu/udi-helpdesk/en/other-relevant-information/medical- device-classification.html
46 Guidance. List of UK approved bodies for medical devices
https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices
86. Devices in Great Britain are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which, prior to the end of the transition period (following the UK’s departure from the EU), gave effect in UK law to the directives listed below: 47
Directive 90/385/EEC on active implantable medical devices (EU AIMDD) Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
This means that the current Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.
87. Section 2, Article 2, of the MDR makes it clear that it is the manufacturer's responsibility to assess the conformity of a device. However, the rules vary depending on the type of device and its class. The logic behind conformity is explained in Article 3 of Annex X, which states that the NB shall: examine and assess the technical documentation for conformity with the requirements of this Regulation that apply to the device and verify that the type has been manufactured in conformity with that documentation; review the clinical evidence presented by the manufacturer in the clinical evaluation report per Section 4 of Annex XIV. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or to the clinical condition in which it is utilised, for the purposes of that review; in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation, for the highest-risk devices, clinical evaluations and investigations are necessary.
88. Chapter VI, Article 61 outlines the requirements for these clinical evaluations and investigations. Most of the requirements for evidence fall upon the manufacturer to ‘specify’ and ‘justify’, and still permits the use of ‘equivalence’, which was a major contributor to the metal hip and surgical mesh design faults that caused many harms. Perhaps the most significant part is as follows: The MDR sets out that a clinical evaluation shall follow a defined and methodologically sound procedure. Note that the responsibility for producing all this lies with the manufacturer.
89. Supervision and follow-up: NB and manufacturers are liable to unannounced inspections by the NB, which in turn are subject to an audit of a sample of documentation. Conformity will be the responsibility of a single identified person for each device. There is no mandatory reporting of adverse events, but healthcare professionals are “encouraged" to report them.
90. The setting up of the European Database on medical devices (Eudamed Article 33) The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes:(a) to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators; The functional specifications have to be drawn up, and an implementation plan was supposed to be fully functional by 25th March 2020. However, if unforeseen circumstances prevent Eudamed from being fully functional on 26 May 2020, the date will be moved to six months after the date of publication of a notice in the Official Journal of the European Union. Until Eudamed is fully functional, the corresponding provisions of the previous Directives will continue to apply.
47 Guidance Regulating medical devices in the UK. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
The latest information indicates that the transition period for the full implementation has been extended to at least Q2 2027. 48
91. The UK and the EU have different regulations for medical devices, even though the UK previously followed EU rules. During the UK's transition period for medical device regulation, there has been a move towards the UKCA marking for products sold in Great Britain. While the EU CE marking is still accepted for placing devices on the market in Great Britain, this arrangement is temporary and will not last indefinitely.
92. Since 1 January 2021, several changes have been introduced through secondary legislation regarding the placement of medical devices on the market in Great Britain (England, Wales, and Scotland).
● All medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices, systems, and procedure packs, must be registered with the MHRA before they are placed on the UK market.
● A medical device manufacturer based outside the UK that wishes to place a device on the Great Britain market needs to appoint a single UK responsible person for all their devices, who will act on their behalf to carry out specified tasks, such as registration.
● General medical devices compliant with the EU Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market until the sooner of the certificate's expiry or 30 June 2028.
● In vitro diagnostic medical devices (IVDS) compliant with the EU In Vitro Diagnostic Medical Devices Directive (IVDD) can be placed on the Great Britain market until the sooner of the expiry of the certificate or 30 June 2030.
● General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR), can be placed on the Great Britain market up until 30 June 2030
Summary recommendations
Recommendation 1: Implement a comprehensive National Breast Implant Registry that annually includes all retrospective patients and reports outcomes.
Manufacturers are required to actively gather information from post-marketing experiences and update their technical documentation accordingly. They must also take an active role during the post-market phase by systematically collecting data about their devices, updating their technical documentation, and cooperating with national authorities responsible for vigilance and market surveillance.
The only way to achieve effective oversight is through establishing national registries that mandate data collection. Without this requirement, we risk continuing the inconsistent and uncoordinated approach to post-marketing that has plagued the past, ultimately rendering regulatory requirements largely ineffective.
48 Commission Publishes New EUDAMED Timeline: Delayed Until at Least 2027 https://casusconsulting.com/eu-commission- updated-eudamed-timeline_deadline-2027/
Recommendation 2: Provide an annual review of the evidence of known harms of breast implants, with yearly communications to the public of the known risks
Integration of the registry data with adverse event reporting and the latest research literature provides the means for informed consent.
Consent is a fundamental legal and ethical principle. All patients have the right to be involved in their treatment and care decisions and to make informed decisions, if possible. The exchange of information between medical professionals and patients is crucial for making informed decisions. In the absence of an annual update, it is unclear how patients can be informed about the actual harms of breast augmentation.
According to GMC Guidance for Doctors, 'Decision making and consent', you must give patients the information they want or need to make a decision, including the potential benefits, risks of harm, uncertainties about, and likelihood of success for each option, as well as the option to take no action. By ‘harm’ we mean any potential negative outcome, including side effects or complications. *By ‘harm’ we mean any potential negative outcome, including a side effect or complication.
Recommendation 3: Determine the risk associated with cosmetic tourism for breast augmentation and the impact on the health system.
Investigating the phenomenon of cosmetic tourism of UK patients for breast augmentation, along with its outcomes and potential complications, should provide essential insights for patients contemplating undergoing this procedure overseas. Systematic review evidence reports that tourism for breast augmentation led to reports of sepsis, irreversible hypoxic brain injury, and death. Analysing the experiences of those who travel abroad for cosmetic surgery can help identify the risks involved and deepen our understanding of how such practices impact the healthcare system. The findings should ensure that patients are better informed and supported in their decisions.
Recommendation 4: Insurance should be a mandatory cost of breast augmentation
In April 2024, a woman left in constant pain because of a ruptured faulty breast implant had to pay
£11,000 for private surgery because the NHS waiting list was too long. The private clinic that fitted the implants refused to remove them, and there was a 12-month wait for NHS corrective surgery. Estimates report that nearly 50,000 UK women had the PIP implant fitted before they were banned in 2010.
Complications with implants should be expected; therefore, insurance at the time of the operation should be included in the implant cost to ensure sufficient coverage for both expected and unexpected future harms.
Recommendation 5: Reiterate the 2012 NHS commitment to support Breast Implant patients irrespective of who did the original operation, with the following NHS actions:
All women who have received an implant from the NHS will be contacted every two years to inform them that they have a PIP implant and to provide updated, relevant information and advice.
In the meantime, NHS patients can seek information about the make of their implant free of charge.
Women who wish to can seek a consultation with their GP or the surgical team that carried out the original implant to get clinical advice on the best way forward. If the woman chooses, this could include an imaging examination to see if there is any evidence that the implant has ruptured.
The NHS will support the removal of PIP implants if a woman, with her doctor, decides that it is the right thing to do, informed by an assessment of clinical need, risk, or the impact of unresolved concerns.
The NHS should also replace implants, regardless of who performed the original operation.
Recommendation 6: Publish transparent regulatory evidence underpinning approved breast implants.
The purpose of the European Database on Medical Devices (EUDAMED) is to provide a transparent view of the lifecycle of medical devices made available in the European Union (EU). EUDAMED aims to enhance transparency through better access to information for the public and healthcare professionals.
EUDAMED is supposed to include the details of registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
Recommendation 7: Publish approved bodies' evidence on breast implants, including audit information, and ensure a duty on manufacturers to inform approved bodies of any manufacturing changes to the product
Manufacturers are liable to unannounced inspections by Notified Bodies and Approved Bodies, which are in turn subject to an audit of a sample of their documentation.
Recommendation 8: Clinical trials must have a sufficient sample size and duration for new breast implant products to ensure safety.
A Class III FDA classification means manufacturers had to provide clinical trial evidence proving the implants were safe and effective through the Premarket Approval (PMA) process. The EU Medical Device Regulation (MDR) requires manufacturers to demonstrate the safety and performance of their products using clinical data, which may include the results of clinical trials. However, Article 61 outlines that most of the requirements for evidence fall upon the manufacturer to ‘specify’ and ‘justify’. Still, it permits the use of ‘equivalence’, a major contributor to the metal hip and surgical mesh design faults that caused many harms.
In the Regulation of medical implants in the EU and UK, Fifth Report of Session 2012–13 transcript reported that ‘implants approved on equivalence should be marked in a manner similar
to the Black Triangle Scheme, which is used to monitor new medicines that have been
approved for use on limited clinical data.’ 49 We recommend that no class III device should be marketed with evidence from at least one randomised controlled trial.
Recommendation 9: Transfer the joint registry responsibilities to a competent organisation that can publish and update meaningful data.
The National Joint Registry, which serves as a model for effective data management, achieves transparency regarding the outcomes of joint replacement surgery. The data in the breast implant registry should be presented more clearly and consistently. With the dissolution of NHSE, a proficient organisation that can effectively curate and report the registry data promptly is needed.
Recommendation 10: No breast implants should be used in humans without clear evidence from an updated register, post-marketing surveillance data, and published evidence from approved bodies at the time of approval.
49House of Commons Science and Technology Committee. Regulation of medical implants in the EU and UK. Fifth Report of Session 2012–13
https://publications.parliament.uk/pa/cm201213/cmselect/cmsctech/163/163.pdf
We recommend suspending all insertions of invasive cosmetic devices until these conditions are met, as informed consent cannot be given without this data being accessible to both physicians and recipients. Consent is a fundamental legal and ethical principle. All patients have the right to be involved in decisions about their treatment and care and to make informed decisions, if possible. The exchange of information between medical professionals and patients is crucial for making informed decisions.
According to GMC guidance, doctors must give consent that includes the potential benefits, risks of harm, uncertainties about and likelihood of success for each option, including the option to take no action. By ‘harm’ we mean any potential negative outcome, including side effects or complications. By ‘harm’, the GMC means any potential negative outcome, including a side effect or complication.
Witness Expertise Carl Heneghan
He is Professor of Evidence-Based Medicine at the University of Oxford, Director of the Centre for Evidence-Based Medicine, and an active NHS Urgent Care General Practitioner (GMC no. 4731643). He is a clinical epidemiologist with expertise in evidence-based medicine, research methods, and evidence synthesis. He has over 450 peer-reviewed publications, a current H-index of 97, and has published more than 100 systematic reviews. His work includes investigating evidence for the approval of drugs and devices, assessing health claims, and researching common presenting conditions in the community. In addition, he has expertise in medical device regulation, diagnosis, medical screening and assessing avoidable harms. He has served as a clinical advisor to three UK All-Party Parliamentary Groups, an adviser to governments, and as a contributor to the WHO clinical trials registry platform. He is a founder of the AllTrials campaign. I have been twice voted one of the top 100 NHS clinical leaders by the HSJ. In 2018, I was awarded NIHR Senior Investigator status. He has chaired the WHO guidelines on breast cancer screening and has published previously on breast implants.
Tom Jefferson
Dr. Tom Jefferson is a Senior Associate Tutor at the University of Oxford, a former researcher at the Nordic Cochrane Centre, and a former scientific coordinator for the production of HTA reports on non- pharmaceuticals for Agenas, the Italian National Agency for Regional Health Care. He is a medically Trained Epidemiologist with extensive experience in HTA and handling large datasets, including regulatory dossiers, clinical data synthesis, systematic reviews, health economics studies, and meta- analysis within medical devices and pharmaceutical companies. He has conducted health economics modelling and scholarly work in the past and has a firm grasp of regulatory processes in the EU. He is a member of Cochrane and EUNeHTA.
Tom Jefferson and Carl Heneghan have published several articles on Trust the evidence on device failings (https://trusttheevidence.substack.com/)
Conflicts of Interest Statement:
Carl Heneghan
CJH holds grant funding from the National Institute for Health Research (NIHR). He has received financial remuneration from an asbestos case and has given legal advice on mesh, hormone pregnancy test cases, and sodium valproate. He has received expenses and fees for his media work. He receives expenses for teaching evidence-based medicine and is paid for his general practice work in the NHS out of hours (Oxford Health NHS Foundation Trust). He has also received income from publishing a series of toolkit books and appraising treatment recommendations in non-NHS settings. He is the Director of the