Objective: This study sought to estimate the incidence and incidence rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a high-volume single institution, which enables vigorous long-term follow-up and implant tracking for more accurate estimates. Summary Background Data: The reported incidence of BIA-ALCL is highly variable, ranging from 1 in 355 to 1 in 30,000 patients, demonstrating a need for more accurate estimates. Methods: All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively identified. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan–Meier estimator and life table. Results: During the 26-year study period, 9373 patients underwent reconstruction with 16,065 implants, of which 9589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1000 patients (1 in 559) with textured implants and 1.15 per 1000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range, 6.4–15.5 yrs). Time-to-event analysis demonstrated a BIA-ALCL cumulative incidence of 0 at up to 6 years, increasing to 4.4 per 1000 patients at 10 to 12 years and 9.4 per 1000 patients at 14 to 16 years, although a sensitivity analysis showed loss to follow-up may have skewed these estimates. Conclusions: BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing over time, particularly in patients exposed to textured implants for longer than 10 years.
Objective To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants.Design Systematic review of clinical trials, observational studies, and registries.Data sources Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration.Study selection Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed.Results There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding. ConclusionsThere is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.
reast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern impacting millions of women with textured implants. A decade ago, the risk for developing BIA-ALCL was thought to be as low as 0.1-0.3 per 100,000 patient years; however, current estimates indicate that the incidence of BIA-ALCL may be much higher. [1][2][3] Two recent analyses from a large cohort of patients with long-term follow-up at our institution suggest that the risk for BIA-ALCL may be as high as 1 in 559 women, with an average time to diagnosis of 10 years. 2,3 Notably, a time-to-event analysis suggests that the risk of developing BIA-ALCL increases over time. 2 This is particularly alarming to the thousands of women with textured implants who have yet to approach this 10-year mark. 1 The rising incidence of BIA-ALCL has increased awareness of an association between textured implants and the development of the disease. In July 2019, the US Food and Drug Administration (FDA) issued a recall of all Allergan Natrelle BIOCELL-textured breast implants, often classified as macrotextured devices. 4,5 Although these devices may no longer be used for reconstructive or aesthetic breast surgery, developing a management strategy for asymptomatic patients with textured implants who fear they may be at risk
There was an overall decline in rates of pediatric FHs in this time period driven by a decline in unintentional-FHs. However there was an increase in assault FH among black children during this same time period.
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