PDF
Citation
Print
In the present article, the authors have tried to discuss the emerging crisis of stakeholders in implant-based breast augmentation mammoplasty and to propose a multidisciplinary approach for the early detection of complications.1 However, the only finding with any basis of evidence in the “Methods” and the “Results” sections is that the awareness of patients regarding the information of breast implants was slightly different from the sonographic findings (78.95% vs. 85.09%). Based on this result, the authors have elaborated on their alarming claim, namely the alleged “conflict of interest” that plastic surgeons in Korea supposedly have (“something-for-something relationship” to quote the manuscript) and the “inappropriate approval process” of breast implants by the Korean Ministry of Food and Drug Safety (KMFDS). In addition, they have suggested a “multidisciplinary approach” to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). We fail to understand the relationship between the results of the study and the statements in the discussion. In other words, it is highly unclear what the authors intended to show in view of their study results. This manuscript causes confusion in the minds of readers by arriving at a completely different conclusion with no basis.
Conflict of interest is a critical issue and every physician should be aware of it. Surgeons should select the type of breast implant based on patients' pre-operative physical characteristics, personal preference, and legal availability and the decision should not be biased by the surgeons' tangible or intangible profits. However, in this article, the authors have rushed to accuse the plastic surgeons who have used textured implants, implying personal benefits. Too put this softly, this is a very serious claim. Respectfully, we would like to give the authors a chance to contemplate whether they really think plastic surgeons have used textured implants due to a “something-for-something” relationship with the manufacturers. We also question the authors' opinion on the abundant prospective and retrospective articles that have extensively studied the advantages of textured implants.23456789101112 Have the studies reported these results on behalf of the manufacturers or considering their benefits? Above all, how do the results of the present study (the sonographic findings of breast implants) lead to the preposterous opinion on the conflict of interest?
Because we do not represent the KMFDS, we will not provide a detailed explanation about their approval process. However, it is unclear how the results of the present study (the sonographic findings of breast implants) lead to this claim against the KMFDS.
The authors have also attempted to discuss their multidisciplinary algorithm for BIA-ALCL. However, we cannot find nothing new from it. As recommended by many nations that have years of experience in treating BIA-ALCL before us, BIA-ALCL should be approached with the involvement of professionals from multiple disciplines including oncologists, pathologists, surgical oncologists, radiation oncologists, and plastic surgeons, since the treatment strategy can vary depending on the stage and unlike other types of lymphoma, the mainstay of treatment for BIA-ALCL is surgical excision (en bloc capsulectomy), especially for early-stage patients.1314 However, in the present article, the aforementioned points are not discussed. We would like to know what the authors' multidisciplinary algorithm means.
In addition to the aforementioned inquiries, we would like to provide our readers with some refreshing facts. In collaboration with the KMFDS, the Korean Society of Plastic and Reconstructive Surgery has been sharing safety information about textured implants in a variety of forms. They have formulated an informed consent, which describes the potential benefits and risks of textured breast implants including the risk of BIA-ALCL. They have also set up a web portal, which has comprehensive information on BIA-ALCL open for anyone to see.15 From this website, patients can obtain extensive information on BIA-ALCL including what BIA-ALCL is, its presentation in patients, follow-up guidelines, the current status of BIA-ALCL occurrence in Korea, lists of regional centers that patients with suspicious symptoms can visit, and even compensation information provided by the manufacturers. They have also established an early reporting system for patients with suspicious symptoms of BIA-ALCL.16 In this system, plastic surgeons can report the clinical information of patients with suspected BIA-ALCL before and after the final diagnosis. All confirmed cases in South Korea (n = 2) have been reported and can be tracked within this system from the initial diagnosis to the postoperative follow-up.
Finally, we would like to point out that the indication for ultrasonography in the present study is very vague. The authors have stated that the majority of patients (82.46%) underwent ultrasonographic evaluation as a “routine check-up.” What does “routine check-up” mean? Is it for the early detection of breast cancer or that of BIA-ALCL? If it is for breast cancer, it is a completely different issue. If it is for BIA-ALCL, the benefit of screening ultrasonography for asymptomatic patients lacks clinical evidence. According to the current National Comprehensive Cancer Network guidelines, sonographic evaluation is recommended for patients with suspicious symptoms (effusion, enlargement, mass, and ulceration) on physical examination.17 The most common presentation of BIA-ALCL is a large periprosthetic fluid collection (seroma), and to confirm the diagnosis, a minimum of 50 cc of seroma should be collected.14 Patients with this amount of seroma usually experience a change in the size and the shape of their breasts. Hence, many prior clinical studies have recommended follow-up of asymptomatic patients without further evaluation. With “routine” sonographic evaluation, small collections of seroma can be detected in many asymptomatic patients. However, its clinical significance is questionable, as benign seroma is not rare after breast augmentation or reconstruction and the diagnosis of BIA-ALCL cannot be made with inadequate specimens.
In conclusion, the only tangible result of the present article is that the patients' awareness of the information of breast implants was slightly different from the sonographic findings. The assertions following the result are neither logical nor grounded. Routine sonography to evaluate breast implant status cannot be justified solely on the basis of these results. The completely unrelated claims involving conflict of interest and the approval process of medical devices are even more concerning.
XML Download