Singh Mansher, Singh Gayatri, Singh Chauhan Anupam, Lee Harrison H, Sacks Justin M, Hultman Charles S, Albert Mark G
Department of Plastic Surgery, Johns Hopkins School of Medicine, Baltimore, Md.
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Plast Reconstr Surg Glob Open. 2020 Nov 23;8(11):e3240. doi: 10.1097/GOX.0000000000003240. eCollection 2020 Nov.
In the United States, the Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, and medical devices. In that role, FDA releases timely updates with regard to medical devices and their possible adverse effects. However, the impact of such FDA updates on public interest has not been studied. The timing of multiple FDA updates regarding Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) was noted from September 2014 to September 2019. Impact on Public interest related to ALCL was measured using Google Trends and the number of YouTube video uploads. These objective markers were used to compare the public interest during FDA updates versus weeks with no FDA updates. Five major updates were released by FDA regarding BIA-ALCL during the past 5 years. Google Trends demonstrated a significant increase in public interest regarding ALCL during the week of FDA release, with a mean score of 69 ± 20.82 when compared with a mean score of 10.68 ± 4.71 ( < 0.001) during weeks with no FDA release. The mean number of YouTube videos uploaded during the period of FDA release was 11.8 ± 9.42, which was significantly higher than the mean of 2.42 ± 1.31 videos ( < 0.001) during the period of no FDA updates. FDA updates correlates with temporal increase in public interest. Plastic surgeons should be aware of FDA information releases on BIA-ALCL and anticipate an increased interest in additional information from patients and the public.
在美国,食品药品监督管理局(FDA)负责通过确保药品、生物制品和医疗器械的安全性、有效性和安全性来保护公众健康。在此职责下,FDA会及时发布有关医疗器械及其可能的不良反应的更新信息。然而,尚未研究此类FDA更新对公众利益的影响。记录了2014年9月至2019年9月期间FDA关于乳房植入物相关间变性大细胞淋巴瘤(BIA-ALCL)的多次更新时间。使用谷歌趋势和YouTube视频上传数量来衡量与ALCL相关的公众利益影响。这些客观指标用于比较FDA更新期间与无FDA更新的几周内的公众利益。在过去5年中,FDA发布了5次关于BIA-ALCL的重大更新。谷歌趋势显示,在FDA发布的那一周,公众对ALCL的关注度显著增加,平均得分为69±20.82,而在无FDA发布的几周内平均得分为10.68±4.71(P<0.001)。在FDA发布期间上传的YouTube视频平均数量为11.8±9.42,显著高于无FDA更新期间的平均2.42±1.31个视频(P<0.001)。FDA更新与公众利益的暂时增加相关。整形外科医生应了解FDA关于BIA-ALCL的信息发布,并预计患者和公众对更多信息的兴趣会增加。