Implant firm 'also made testicles'
Thursday 05 January 2012
The firm at the centre of the breast implant scandal also made male chest and testicle implants filled with the same silicone gel, it was reported today.
The male implants are believed to have been exported worldwide but it is unknown how many men had them fitted, according to the French daily newspaper Le Parisien.
It said former employees of the now-closed French company PIP said the firm also created prosthetic silicone testicles - used following surgery for testicular cancer - and chest implants.
Around 40,000 women in the UK have received breast implants manufactured by PIP.
More may also have travelled abroad for cheap surgery in clinics using the implants.
Some British women may also have received Rofil M implants, which were produced by PIP, and used in overseas clinics.
The Medicines and Healthcare products Regulatory Agency (MHRA) said today that concerned women fitted with Rofil M implants should contact their GP or surgeon.
"Our records show that no Rofil M implants were supplied to UK clinics and hospitals," a statement said.
"If women have been abroad to have Rofil M breast implants, our advice to them, as for women with PIP implants, is that they should not be unduly worried.
"If they have concerns they should speak to their implanting surgeon or GP."
The latest development comes as the Government prepares to issue advice to women tomorrow over PIP implants following a review of the evidence.
In France, officials have told women they should have the implants removed after they were found to contain non-medical grade silicone intended for use in mattresses.
Experts in the UK, including leading plastic surgeons, have been examining British data on rupture rates as well as concerns around the material used in the implants.
The MHRA has said its figures indicate 1% of implants in the UK have ruptured and insists it has found no evidence of a link with cancer, as reported in one French case.
But experts have cast doubt on the UK data, with Fazel Fatah, who is sitting on the Government's review panel, saying there were simply no firm figures in the UK on what proportion of devices had ruptured.
He said there could be a "significant number" of silent ruptured implants that nobody knows about, while a significant number of patients may also not have returned to the clinic where they had their surgery if they suffered a rupture.
His views are backed by another member of the review panel, Tim Goodacre, who also called for all women who have the implants to have them removed because of the "uncertainty and lack of knowledge".
The MHRA said no male implants manufactured by PIP had been distributed in the UK.
A statement said: "No other types of PIP implants - no male PIP implant products - have been distributed in the UK.
"MHRA has checked its adverse incident database and established that we have received no adverse incident reports relating to any PIP implants other than breast implants."
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