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

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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

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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

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Image credits: FDA, BD

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