Worldwide Recall On Allergan Textured Breast Implants

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.

More from Recalls

One Death Linked To Calyxo Urological System

 

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

Class I Recall On Medtronic Embolization Device After 4 Deaths

 
• By 

The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.

Recall Alerts For Boston Scientific, Philips, J&J, And More

 
• By 

The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.

Class I Recalls Hit 15-Year High, According To Index Report From Sedgwick

 

Medical device recalls exceeded 1,000 in 2024, according to a recently published recall index report from Sedgwick. More than 10% of those recalls were class I, the FDA’s most serious category.

More from Policy & Regulation

HHS Has ‘Utterly Failed,’ Kennedy Advisor Argues

 
• By 

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Some Staff Say Makary’s First Speech To FDA Off-Target Despite Science Focus

 

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry

 
• By 

Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.