FDA News: Breast Implants Risk, Prevent Illegal Products entering US, Lead Testing Issues – Drug and Device Digest

Capture.JPGFDA 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


Capture.JPGFDA 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


Capture.JPG 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

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