FDA/CDC
FDA/CDC
FDA opts not to ban textured breast implants
Data link breast implant–associated anaplastic large cell lymphoma to textured devices, but the FDA allowed continued U.S. sales.
News from the FDA/CDC
CDC warns against misuse of opioid-prescribing guideline
Officials at the Centers for Disease Control and Prevention are advising against misapplication of the agency’s guideline on opioid prescribing....
FDA/CDC
FDA orders companies to cease all sales of transvaginal mesh for POP repair
The manufacturers didn’t provide the required safety and efficacy data in their premarket applications.
Commentary
Powerful breast-implant testimony constrained by limited evidence
SILVER SPRING, MD. – Women report personal horror stories of apparent breast-implant complications, but systematically-collected data remain...
FDA/CDC
FDA chief calls for release of all data tracking problems with medical devices
The FDA is “realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in...
Conference Coverage
FDA panel calls for changes to breast implant rupture screening
The advisory panel seemed the current implant screening recommendation using MRI “useless.” They urged the adoption of ultrasound as a more...
FDA/CDC
FDA committee advises status quo for blood supply Zika testing
FDA/CDC
Scott Gottlieb to step down as FDA commissioner
Scott Gottlieb, MD, will be stepping down from his post as commissioner of the Food and Drug Administration in about a month.
FDA/CDC
FDA panel tackles mesh for anterior repair of POP
Patient-reported outcomes should trump anatomic outcomes as FDA evaluates marketed devices.
FDA/CDC
FDA: 246 new reports on breast implant-associated lymphoma
The latest update from the Food and Drug Administration includes medical device reports between September 2017 and September 2018.
FDA/CDC
Device approved to treat PDA in premature infants
The FDA nod is the first for use in very-low-birth infants