Devices

FDA Disagrees with Breast Implant Safety Findings

FDA is disputing findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions, such as rheumatoid arthritis and scleroderma, in patients with breast implants. “We respectfully disagree with the authors’ conclusions,” an agency notice says. “In our editorial response, we note our concerns with significant shortcomings with the study’s methodology and how the data is presented and concluded, including inconsistencies in the data and potential sources of bias. Because of these concerns, we urge the public and healthcare community to view this external assessment’s conclusions with caution.”

FDA says that current data do not “conclusively demonstrate an association between breast implants and connective tissue diseases,” and that the studies published in the Annals “contribute to our discourse on this topic, but more evaluation is required.”

To monitor postmarket safety on breast implants, FDA says it has coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis. “The data collected from this registry as well as medical literature, meetings with patient advocates, and our own post-approval studies have contributed to our understanding of BIA-ALCL and our communication updates to the public regarding BIA-ALCL,” it says.

Additionally, FDA is working with multiple stakeholders to develop the National Breast Implant Registry (NBIR) to provide a platform for evaluating real world data on the safety and performance of breast implants. “We have heard from patients who are concerned that their implants may be connected to other health conditions, like chronic fatigue, cognitive issues and muscle pain,” the agency says. “While the FDA does not have evidence suggesting breast implants are associated with these conditions, information from NBIR may help us identify risk factors for complications, such as a patient’s own medical history, the specific type of operation, the type of implant used, and concomitant use of other medical devices.”

Going forward, FDA says it intends to hold a public meeting of the General and Plastic Surgery Devices Panel in 2019 to ensure that patients and health care providers continue to have accurate, scientifically sound information about breast implant safety and effectiveness, and to promote public dialog on the issue.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome