FDA updates public information about known risk of lymphoma from breast implants
FDA identified possible association between breast implants and anaplastic large cell lymphoma (ALCL) in 2011
- Gathering information to better characterize and quantify risk
- Updating total number of known cases of BIA-ALCL and lifetime risk of developing BIA-ALCL
Reporting 414 total cases of BIA-ALCL
- Lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.
Does not change the agency’s recommendations regarding breast implants
- Choosing breast implant is personal decision
- Decision on individual needs and with the most complete information about risks and benefits
FDA Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering US
FDA closely monitor’s products arriving at the nation’s international mail facilities
- Increasingly challenging task given high volume (>275 million packages/yr)
- Deploy advanced screening technologies to screen packages more efficiently and reliably
Successful six-month pilot with portable screening device – ion mobility spectrometer
- Compares chemical signature of unknown substance against chemical signatures of known compounds in less than 30 seconds
- 65% samples tested positive for undeclared pharmaceutical ingredients – results confirmed in FDA laboratory
- Developing opioid screening method for the device
FDA’s findings from ongoing investigation into lead testing issues
Warning in 2017 about inaccurate lead tests by Magellan Diagnostics
- Aggressively investigated problem
- Becton Dickinson (BD) & Company, the manufacturer of blood sample collection tubes also investogated
Assessment of accuracy of Magellan’s LeadCare when used with blood collected into BD tubes
- Significant chance of false results with tubes with rubber stoppers containing thiuram
- Can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles
BD recalls EDTA Blood Collection Tubes Due to Chemical Interference with Certain Tests
Image credits: FDA, BD