Breast implant recall Regulator in talks with Allergan

The Australian regulator TGA (Therapeutic Goods Administration) has said it is aware that Allergan textured implants and tissue expanders are no longer being supplied in the European Union as of December 17, 2018. The TGA will determine, following further discussion with Allergan Australia, what is an appropriate course of action here, it said. The TGA has been advised that the European conformity assessment certificate (referred to CE approval or EC Certificate) for Allergan’s range of textured breast implants and tissue expanders expired on December 17, 2018. The European Notified Body (GMED) which is an organisation that undertakes medical device technical evaluations, notified the French regulator (ANSM) it had requested Allergan to provide (by March 31, 2019) an updated technical file so that further clinical evaluation could be undertaken, the TGA said. Medical device recalls are under the scanner in India, following the controversy arising out of J&J’s recall of faulty hip implants in 2010.

A US Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection. Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.“We are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones,” the FDA said. Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.

The European Medicines Agency (EMA) has published a plan outlining how it would respond to an emerging cross-border threat to health, such as an influenza pandemic. The health threats plan is based on the Agency’s pandemic influenza plan published in 2006 and reflects experience gained during the 2009 (H1N1) influenza pandemic as well as the Ebola outbreak in Western Africa in 2014-2016. The plan would also be triggered in the event of acute hazards including threats of chemical, environmental and unknown origin.

Planning for, responding to and communicating on serious health threats is a priority in the EU Medicines Agency Network Strategy to 2020 and complements ongoing European Commission initiatives in this area. It is an essential element in enabling the European Union and its Member States to better protect citizens in the event of a public health crisis. Because of the international context of health threats, support to international efforts is to be expected, the EMA said.

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