Food and Drug Administration (FDA)

Grafton, R. Quentin; Nelson, Harry W.; Lambie, N. Ross; Wyrwoll, Paul R.

doi:10.1007/springerreference_32222

Cited by 40 publications

(5 citation statements)

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“…Detailed analysis of abdominal versus MIS surgery and the Gynecologic Oncology unit versus the MIS unit indicated that an important factor influencing the rate of occult LMS was the preselection of patients with presumed myomas to abdominal surgery or MIS procedures, which could have minimized the rate of LMS morcellation. The results show that the use of morcellation for all suspected myomas may introduce a level of risk similar to both FDA calculations; 1:498 [4] and 1:495 to 1:1100 [13] of occult LMS. Paradoxically, in the MIS unit, with a significantly higher rate of power morcellation, the risk of encountering occult LMS was lower than in the gynecologic oncology unit due to the different prevalences of LMS (0:1712 vs 6:963, respectively).…”

Section: Discussionsupporting

confidence: 63%

“…The incidence of occult LMS may be very low in MIS centers after appropriate preselection without significant risk of power morcellation. The FDA position after a recent review of the literature is the same as the previous [13], and power morcellators are contraindicated for removal of myomas in the majority of cases. From our European perspective, it is pivotal that well-balanced European Guidelines be developed by the main professional societies, considering advantages and disandvatages of these procedures in specific groups of women.…”

Section: Discussionmentioning

confidence: 91%

“…However, 9 of 10 women with LMS were peri-or postmenopausal and over 50 years of age. The FDA emphasizes [13] that sarcomas in women undergoing surgeries due to presumed myomas approaches 2-3% in those over 60 years [19][20][21]. It should be highlighted that leyomyosarcomas often are unidentified before surgery as showed the data from the Cancer Registry of Norway [22], and in the Norwegian cohort, power morcellation of LMS has not led to reduced survival.…”

Section: Discussionmentioning

confidence: 99%

“…In our study the woman with LMS who underwent power morcellation is 1 of 3 women with the longest survival after LMS recognition from the case series. However, several new studies included in the recent FDA review [13] provide some evidence supporting an increased risk of relapse and decreased overall survival after power morcellation of LMS [19,23,24]. Conversely, another interpretation of the available data suggests that even intact removal of LMS has no advantage for mortality rate compared with power or any other type of morcellation [25].…”

Section: Discussionmentioning

confidence: 99%

“…After a well-educated injured patient pointed out the underestimation of occult malignancy risk and questioned the safety of power morcellation, a polarizing debate [1][2][3] began which resulted in the first estimation of the prevalence of occult LMS by the Food and Drug Administration (FDA) [4] and a significant restriction in the use of morcellators in clinical practice in the United States. The prevalence of unexpected LMS varies from 1:495 to 1:1100, by FDA estimations, to 1:8000, depending on the analytical method used [5,6].…”

Section: Introductionmentioning

confidence: 99%

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Occult uterine leiomyosarcoma in women undergoing abdominal and minimally invasive surgeries for myomas

2018

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Objectives: To estimate (i) the incidence of occult uterine leiomyosarcoma (LMS) in patients operated on for presumed myomas, and (ii) the proportion of occult LMS to preoperatively diagnosed LMS in a tertiary center. Material and methods: An Institutional Review Board-approved retrospective cohort study was performed. The electronic database of 30,476 patients was searched for women who had undergone surgery due to presumed myomas (N = 2675) as well as those with uterine LMS recognized via histology (N = 10) between January 2010 and December 2016. Results: Six of the 2675 treated women had occult LMS (incidence 1:446; 0.002; CI 0.0-0.013), and one underwent power morcellation (incidence 1:951; 0.001; CI 0.0-0.006). Parallel searching revealed that 6 of the 10 cases (60%) with uterine LMS recognized via histology were diagnosed postoperatively, whereas 4 of the 10 (40%) were diagnosed preoperatively. The incidence of LMS morcellation during laparoscopy was 1:951 and, when all MIS cases were included, 1:1178. The patient who underwent LMS morcellation was operated in the general surgery ward 5 years after laparoscopy (omental recurrence). Conclusions: These results are similar to the first and recent conservative FDA estimations, but two-times lower for procedures with laparoscopic morcellation and all MIS procedures than for abdominal. Because above half of LMS may be recognized after surgery, the risk of occult LMS and the delay of targeted surgical treatment should be included in all informed consent forms for conservative management of presumed myomas without histology.

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Section: Discussionsupporting

confidence: 63%

Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Occult uterine leiomyosarcoma in women undergoing abdominal and minimally invasive surgeries for myomas

2018

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Blockchain-Based Traceability System for Product Recall

Kravenkit

So-In

2022

IEEE Access

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In this paper, we propose a blockchain-based framework involving a traceability system for product recall (TSPR) designed to develop a traceability system integrated into the product recall system deployed to the Ethereum to ensure the transparency and visibility of the recall process for all stakeholders. The proposed system incorporates all four stakeholders, including supply chain (SC) participants, the food safety regulatory system, the admin, and end customers, into one chain. In the proposed TSPR system, individual components are developed to provide primarily product traceability events, product recall data and status, which are stored in the blockchain to authorized stakeholders. Moreover, the entity relationship and activity diagram of the TSPR system are developed. In the experiment, we develop three smart contracts of the TSPR system using Remix IDE running on an Ethereum test network. A scenario of the events of product traceability and recall in the SC is developed. Two criteria are used to test the validation of contracts: the correct operation and measurement of gas costs. The results show the correctness of three smart contracts, thereby ensuring that the stakeholder chain is provided with visibility and transparency primarily for the product recall process. Moreover, the summation of gas costs deployed in the TSPR system in Ethereum Mainnet for the regulator and manufacturer is $30.23 and $111.54, respectively. However, when using the Polygon Ethereum Virtual Machine (EVM), the gas cost remains $0.022 and $0.083, respectively; thus, we recommend this system for stakeholders to help them achieve lower costs and increased economic worth.

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Defining Risk in Food Safety in the Philippines

Rustia

Tan

Guiriba

et al. 2021

Curr Res Nutr Food Sci

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Food safety is a fundamental public health concern that is dependent on various factors such as changing global food production patterns, public expectations, and international trade policies.1,2 As a member of the World Trade Organization, the Philippines has agreed to follow the Uruguay Round of Trade Organization, the Sanitary and Phytosanitary Agreement and Technical Barriers to Trade that permits countries to take legitimate measures to protect life and health of their consumers in relation to food safety matters while prohibiting them from using those measures in a way that unjustifiably restricts food trade.3,4,5 The Philippines is also a member of the Codex Alimentarius Commission that aims to ensure consumer protection and to facilitate international trade.6 With these objectives, Codex focuses on the development of food standards based on risk analysis and independent scientific advice provided by expert bodies organized by the Food and Agriculture Organization and the World Health Organization.7 Risk analysis is a systematic and disciplined methodology that provides policymakers with the science-based information and evidence needed for effective and transparent decision-making, leading to improvements in food safety and public health.8 In the Philippines, Republic Act No. 10611 or the Food Safety Act of 2013, serves as the framework for implementing the farm to fork food safety regulatory system which ensures a high level of consumer health protection, fair trade practices and global competitiveness of Philippine foods by controlling hazards in the food chain, adoption of precautionary measures based on scientific risk analysis, and adoption of international standards.9

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Food and Drug Administration (FDA)

Cited by 40 publications

References 0 publications

Occult uterine leiomyosarcoma in women undergoing abdominal and minimally invasive surgeries for myomas

Occult uterine leiomyosarcoma in women undergoing abdominal and minimally invasive surgeries for myomas

Blockchain-Based Traceability System for Product Recall

Defining Risk in Food Safety in the Philippines

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