THERE is no medical reason for women who received PiP or M-Implants breast implants to have them removed, public health authorities have said.
“Our recommendation is that these implants do not need to be removed. However, we urge women purely as a precaution to undergo regular checks for the possibility of rupture,” Health Minister Stavros Malas said yesterday.
Christos Merezas, head of the Cyprus Society for Plastic Reconstructive and Aesthetic Surgery, likewise said their recommendation to women is to decide for themselves.
“The data are not sufficient to suggest that removal is imperative. It’s therefore a matter of personal choice. But we urge women, in order that they have peace of mind, to have an ultrasound every six months to ensure no rupture of the implants has occurred,” Merezas told the Cyprus Mail.
Around 100 women have received surgery with PiP or M-implant devices in Cyprus. A handful have received such implants abroad, for example Syria. Since the scare began, a dozen women at the most have had them removed and replaced, said Merezas.
Cyprus is following the recommendation of the British Association of Plastic Surgeons which announced that it would not recommend the replacement of all such implants in the country.
France is the only country to date to announce the wholesale replacement of the PIP implants. France is also the country where the potentially problematic implants were manufactured, and cases of leakage from the implants have been diagnosed there.
The scare began after media reports cited concerns that the implants supplied by French manufacturers Poly Implant Prothese (PIP) carry potential health risks.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced last year that its independent UK tests found no evidence of chemical toxicity or the implants potentially causing cancer to victims.
However, French results later indicated that the implants were more prone to rupture and that more extensive testing on genotoxicity (potential for cancer) was required.
It was also reported that in addition to the PiP silicone devices, there were similar potential problems with implants sold under another trade name, M-implant, of the Dutch company Rofil Medical Nederland.
In March 2010 the International Confederation for Plastic, Reconstructive and Aesthetic Surgery (IPRAS) sent out an alert for the PiP implants after reports they were prone to rupture. A similar alert was issued by IPRAS for M-implants in June 2010.
Since the alerts, neither PiP nor M-implants have been – or should have been – imported or used in Cyprus, Merezas said.
Any potentially faulty implants must therefore have been fitted between 2000 and 2010, he added.
According to the IPRAS alert, the problematic PiP and M-implants used gel from the same manufacturer.
“However, we do not know whether this gel was used in all the batches of these two brands,” Merezas said.
And it’s not a given that implants with that type of gel will rupture, he added.
The Cyprus Society has also urged its members that they should charge women going for removal only for the cost of a new implant and for the anaesthesia, and to waive the surgery fee.
Dutch officials said that the M-implants have the same hazards as the PIP devices. However, it is possible that the M implants marketed in some European countries differ from the ones that were banned in the Netherlands and Germany.
The confusion stems from the existence of two different products under the same name.
The notion of a new type of M-implant stems from a certificate of reliability granted by the Luxembourg licensing authority SNCH in the early part of 2010.
The new types of M-implants have been manufactured by the Cyprus-registered Rofil Medical Implants, after Rofil Medical Nederland filed for bankruptcy in the Netherlands. The two companies have the same owner and CEO.
Rofil Medical Implants, the Cyprus-registered company, says it has ordered breast implants from South Korean company Hans Biomed.
Rofil Medical Implants Ltd was founded in Cyprus in 2009. In addition, prior to the bankruptcy of the Dutch company, a company named Rofil Medical Aesthetics Ltd was also established in Cyprus.
The implants sold by the Cyprus-based company also carry the brand name M-Implant. Rofil Medical Implants Ltd said that, not being aware of the upcoming PIP crisis, it continued using the name M Implant.
According to a press release put out by the manufacturer in November, the size and shape of the new M-implants are completely different from those of the banned PIP implants.
These implants have been sold on the market, but not in Cyprus, since having obtained the CE mark, the company said.
In late December the Health Minister here said the PiP and M-Implants were “one and the same”. Regarding the M-Implants, he referred to the manufacturers as “Rofil” only.
