What's new in December 2011

New for December

• 23 Dec 2011 | Press statement: PIP breast implants – UK medical devices regulator says no evidence to support routine removal
  

  Following the announcement in France today, the MHRA is not recommending routine removal of Poly Implant Prosthese (PIP) silicone gel breast implants in the UK.

• 23 Dec 2011 | Class 2 Drug Alert (Action Within 48 Hours): Lundbeck Limited - Clopixol Conc Injection (500mg/ml) - EL (11)A/33
  

  Lundbeck Limited have informed us that they are recalling batches of Clopixol Conc Injection (500mg/ml) this is because there have been a small number of reports of cracked ampoules and there are concerns that sterility assurance cannot be guaranteed.

• 22 Dec 2011 | Breast Implants
  

  

  Breast implants are regulated as medical devices. We are responsible for ensuring that breast implants meet appropriate standards of safety, quality and performance, and that they comply with the Medical Devices Directive.

• 22 Dec 2011 | European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study - interim advice provided
  

  Routine (non-urgent) review is recommended for patients taking aliskiren-containing medicines. Aliskiren is approved for the treatment of essential hypertension.

• 22 Dec 2011 | Medical Device Alert: Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon (MDA/2011/113)
  

  This Medical Device Alert has been issued as there is a possible failure to deliver therapy under gravity infusion, as these sets may be fitted with anti-syphon valves instead of anti-reflux valves.

• 22 Dec 2011 | Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical (MDA/2011/112)
  

  This Medical Device Alert has been issued as there is a risk of inappropriate therapy due to wear and/or abrasion of lead insulation after implantation when using Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.

• 21 Dec 2011 | Class 4 Drug Alert: B.Braun Medical Ltd - NuTRIflex Lipid products - EL (11)A/32
  

  B.Braun Medical Ltd is issuing advice to filter several batches of NuTRIflex Lipid products due to the possible presence of particulates.

• 21 Dec 2011 | Public consultation (MLX 363): Fees legislation for 2012
  

  This consultation seeks your views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homoeopathic medicines, and blood establishments and blood banks.

• 21 Dec 2011 | Medical Device Alert: Specific model variants of Plum A+ infusion pumps manufactured by Hospira Inc - (MDA/2011/111)
  

  This Medical Device Alert has been issued as there is the risk of over infusion of medication due to failure of the flow regulator when using Plum A+ infusion pumps manufactured by Hospira Inc.

• 20 Dec 2011 | Company-led drug recall: Glucose 5% IV Infusion 500 ml Viaflo - Baxter Healthcare Limited - CLDA(11)A/19
  

  Baxter Healthcare Limited has recalled a batch of this product as two bags have been found to contain paper.