Evidence map›Paper›PMID 36229658›Full record

Observational studyAesthetic plastic surgery2023

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

Guido Paolini, Guido Firmani, Francesca Briganti, Mattia Macino, Simone Nigrelli, Michail Sorotos, Fabio Santanelli di Pompeo

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Aesthetic plastic surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
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  6. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Guido PaoliniNESMOS (Neurosciences, Mental Health, and Sensory Organs) Department, Faculty of Medicine and Psychology, Azienda Ospedaliera Sant'Andrea - U.O.D. Chirurgia Plastica, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy. guido.paolini@uniroma1.it.ORCID 0000-0002-9408-4289
Guido FirmaniFaculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.
Francesca BrigantiFaculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.
Mattia MacinoDepartment of Biomedicine and Prevention, Tor Vergata University, Via Montpellier, 1, 00133, Rome, Italy.
Simone NigrelliFaculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.
Michail SorotosNESMOS (Neurosciences, Mental Health, and Sensory Organs) Department, Faculty of Medicine and Psychology, Azienda Ospedaliera Sant'Andrea - U.O.D. Chirurgia Plastica, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.
Fabio Santanelli di PompeoNESMOS Department, Faculty of Medicine and Psychology, Chair of Plastic Surgery - Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBreast 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.

objectivesFollowing FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases.

methodsIn 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.

resultsWe 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).

conclusionWearing 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 .

Indexed as

Breast ImplantationBreast ImplantsBreast NeoplasmsMammaplastyFemaleFollow-Up StudiesHumansRetrospective StudiesRisk AssessmentRisk FactorsTreatment OutcomeBreast implantsBreast reconstructionImplant ruptureMacrotexturedRupture risk factors

Identifiers

PMID36229658
PMCPMC10070228

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.