1. Medtech Insight
  2. >>Policy & Regulation

Worldwide Recall On Allergan Textured Breast Implants

 
• By Elizabeth Orr

Allergan PLC announced that it would take its Biocell textured breast implants and tissue expanders off the market worldwide shortly after the US FDA released additional information linking the use of the implants to a rare cancer.

Implant

Device manufacturer Allergan PLC announced a worldwide recall of its Biocell textured breast implants and tissue expanders Wednesday morning, shortly after the US Food and Drug Administration released a safety communication citing additional data linking the implants with a rare form of cancer.

The breast implants and tissue expanders have been tied to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a relatively rare disease and type of non-Hodgkin’s lymphoma. In total, the FDA has found 573 unique cases globally of BIA-ALCL and 33 patient deaths – an increase of 116 new unique cases and 24 deaths since September 2018

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Recalls

More from Policy & Regulation

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.