History of breast implants: Back to the future

Pompeo, Fabio Santanelli di; Paolini, Guido; Firmani, Guido; Sorotos, Michail

doi:10.1016/j.jpra.2022.02.004

Cited by 40 publications

(18 citation statements)

References 89 publications

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“…Despite our best efforts, the use of unconventional methods for calculating BI prevalence will never surpass mandatory reporting in NBIRs [ 30 ]. Therefore, we strongly support recommendations of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)’s to implement their use [ 2 ] for obtaining a better estimate of risks related to BI complications. In Italy, despite the implementation of Law n°86 on the 5th of June 2012 [ 31 ] for the creation of regional and national breast implant registries, nearly 10 years since the law’s enactment, the country’s tracking efforts are limited to a pilot study in 2019, with 269 participating surgeons as of September 2021: [ 32 ] a number far from the required standards to generate widely applicable data.…”

Section: Discussionmentioning

confidence: 53%

“…The US Food and Drug Administration recently issued several orders to strengthen breast implant (BI) risk communication including restricting implant sales, boxed warnings, mandatory informed consent checklists, and updated surveillance recommendations [ 1 , 2 ]. In 2021, the scientific committee on health, emerging and environmental risks (SCHEER) of the European Commission released a detailed review of breast implant safety and updated guidance on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

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Determining Breast Implant Prevalence: A Population Study of Italian Chest Radiographs

et al. 2023

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Background Current breast implant prevalence within the general population remains elusive. An accurate prevalence is critical to serve as the denominator for any assessment of breast implant-related complication. The purpose of this manuscript is to assess this prevalence in women aged 20–70 years in Italy. Materials and Methods Eight reviewers, demonstrating a mean sensitivity of 87.0% and specificity of 97.0%, were recruited for retrospective identification of implants on chest radiographs from a tertiary academic hospital in a major urban setting. Three final reviewers were selected, and they assessed all eligible chest radiographs collected between January and December 2019. The hospital-based population was compared to epidemiological data at a local, regional and national level to demonstrate homogeneity of age structures using the phi correlation coefficient. Results We identified 3,448 chest X-rays which yielded 140 implants, with an overall prevalence of 4.1% for women aged 20–70. Implants were bilateral in 76% of cases and unilateral in 24%. They were placed cosmetically in 47.1% cases and used for reconstruction in 52.9% cases. Phi correlation coefficient found no differences across hospital-based, local, regional and national populations. Conclusion A validated method was performed to estimate implant prevalence from an academic hospital in a major urban setting at 4.1% and was used to estimate national prevalence in Italy. The implications of this epidemiologic study may reach across national borders for improved understanding of breast implant epidemiology and in predicting the total number of patients within a given population that may be affected by device complications. Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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Section: Discussionmentioning

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Determining Breast Implant Prevalence: A Population Study of Italian Chest Radiographs

et al. 2023

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“…Nevertheless, because of missing sales data and the lack of implant registries, it is not possible to clearly define surface-specific incidence rates. Therefore, “high-risk” implants can be considered either only those specific branded types associated with most BIA-ALCL cases, such as Allergan BIOCELL or Silimed Polyurethane-coated devices, or all the textured devices with high surface roughness, so-called macrotextured, hence including more than the previous two [ 46 ].…”

Section: Discussionmentioning

confidence: 99%

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

et al. 2022

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Background Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. Materials and Methods In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women’s life expectancy (WLE) were obtained from a literature review and population database. Results BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. Conclusion This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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“…Nowadays, BI manufacturers recognize rupture as a potential complication [ 15 ].It is also fairly accepted that the longer the indwelling, the likelier it is for patients to experience adverse outcomes requiring surgery [ 16 ]. To strengthen BI safety, the FDA proposed black box warning that includes requesting manufacturers to improve labelling and patient information, outlining implant rupture as a relevant concern [ 17 ], as well as updating rupture screening recommendations [ 18 ]. Other means include pushing for improved reporting strategy of confirmed rupture cases, and conducting Premarket Approval (PMA) Core studies.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants

Paolini

Firmani²,

Briganti³

et al. 2022

Aesth Plast Surg

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Background Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10–15 years. No consensus exists regarding which factors are involved. Objectives Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases. Methods In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR. Results We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347). Conclusion Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged. Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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History of breast implants: Back to the future

Cited by 40 publications

References 89 publications

Determining Breast Implant Prevalence: A Population Study of Italian Chest Radiographs

Determining Breast Implant Prevalence: A Population Study of Italian Chest Radiographs

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants

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