Best Practices Guideline for the Pathologic Diagnosis of Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Purpose: To provide guidelines for the accurate pathologic diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the preoperative evaluation of the patient with suspected BIA-ALCL, and the pathologic evaluation of the capsulectomy specimen.

Methods: To better inform patients and healthcare providers about BIA-ALCL, we convened to review diagnostic procedures used in the evaluation of patients with suspected BIA-ALCL. We focused on the processing of the seroma fluid/effusion surrounding the implant, the handling of capsulectomy specimens following removal of implant(s), and the preoperative evaluation of the patient with suspected BIA-ALCL.

Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Initial Report of Findings, 2012-2018.

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.

Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA.

Laparoscopic trocars, medical devices used to gain access into the abdominal cavity, are the most common device named in malpractice injury claims associated with laparoscopic procedures. As part of its ongoing adverse event reporting program, the U.S.