Some implantable devices are the subject of a medical device alert
A further safety alert has been released by the Medicine and Healthcare products Regulatory Agency (MHRA) in relation to testicular implants and inflatable vaginal stents made by Silimed.
The MHRA has found that these products are actually made under subcontract by Silimed for the manufacturers Coloplast A/S.
As reported previously, unidentified particles found on a number of devices led to Silimed’s CE certificate being suspended.
The alert requires no further affected devices be implanted and those remaining be quarantined. This further warning from the UK healthcare regulator suggests the scale of the contamination is larger than previously thought and may have further implications for consumer safety. The MHRA recommend any one with concerns contact their doctor to discuss this further.