Total hip replacement, partial hip replacement, and revision hip replacement are associated with different rates of postoperative complications and readmissions. Advanced age, comorbidities, and nonelective admissions are associated with inferior outcomes.
Background:
In January of 2011, the US Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large cell lymphoma (ALCL). In August of 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop a patient registry entitled the “Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology” (PROFILE).
Methods:
The first report of the registry findings is presented here.
Results:
From August of 2012 to March of 2018, a total of 186 distinct cases of breast implant–associated ALCL (BIA-ALCL) in the United States were reported to PROFILE. At the time of this present analysis, complete detailed case report forms have been received for 89 (48%) cases. Median time from implantation of any device to BIA-ALCL diagnosis was 11.0 years (range = 2–44 years; n = 89). At the time of presentation, 96% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was a periprosthetic fluid collection seen in 86% of patients. All patients had a history of a textured device; there were no patients who had a smooth-only device history. At the time of initial case report submission, 3 deaths were reported.
Conclusions:
The PROFILE Registry has shown to be an essential tool in unifying the collection of data pertaining to BIA-ALCL. These data have broadened our understanding of the disease and emphasize the critical importance of detailed tracking of BIA-ALCL cases.
ONITORING THE SAFETY OF approved medical productsisofvitalpublichealth importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials. [1][2][3][4][5][6] Within the broad range of medical products, implantable medical devices represent high-risk products that are uniquely challenging to monitor because there is little consensus regarding the most appropriate methods to account for the complex interactions amongdevices,medications,patients,and implanting physicians. In addition, the lack of unique medical device identifiers challenges the effective use of administrative claims data and electronic health records as a primary data source to evaluate manufacturer-specific device safety. 7 To support clinical research and quality-improvement efforts, detailed clinical registries have been established in recent years at the state, regional, and national levels for many high-risk implantable medical devices, [8][9][10][11] which may provide unique opportunities to pro-spectively monitor the safety of such devices. 12 The Massachusetts statewide coronary intervention registry 13 was established in 2003 to monitor the quality of care of hospitals and physicians in the state. This registry is a mandatory clinical outcomes registry based on the American College of Cardiology National Cardiovascular Data Repository (NCDR) CathPCI data set and includes For editorial comment see p 2065.
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