Our Medical and Product Lawyers have a lot of experience in fighting for the rights of those affected by medical device recalls and claims. We have acted for a large number of victims of the PIP breast implant scandal where millions have been recovered in damages for victims.
We recently blogged on the Silimed investigation where contaminant particles were found on devices following an inspection. In an update from the MHRA, a number of Coloplast A/S devices that were made by their subcontractor Silimed lndustria de lmplantes Ltda have had their CE mark revoked.
Testicular implants and inflatable vaginal stents affected
The MHRA has confirmed that the following products have had their CE certification removed:
- Testicular implants with product codes: PR3001, PR3002, PR3003, PR3004, PR3005
- Vaginal stents (inflatable) with product codes: VS3020, VS3022, VS3024, VS3026
Advice so far is to stop any more of the affected devices from being implanted as the investigation in to whether the products pose any danger to patients who have them implanted continues. The investigation has revealed so far that particles have been found on products in the manufacturing process, but the nature and origin of the particles has yet to be fully confirmed.
What does this mean for affected patients?
Its early days in to the investigation and whether the particles pose any danger to anyone affected remains to be seen. But this isn’t the first recall of its nature, as the industry for medical devices continues to face criticism through poor regulation and inadequate testing.
We know all too well the horrors that recalls of this nature can cause. We have seen badly ruptured breast implants and we have fought for justice for the victims who have been left with lifelong injuries and suffering. If the Silimed products affected in this investigation are set to cause problems, our expert lawyers will be taking instructions for anyone affected.
We are looking in to the problem and we will aim to keep you informed if anything sinister should arise.