THE UK’s only manufacturer of breast implants has enjoyed “double digit” growth in sales since the PIP debacle in which thousands of women found their prosthetics were made of sub-medical grade silicone.
Now fears of rupture and possible health effects for women fitted with the sub-standard implants has prompted a director of manufacturer Nagor to demand that the industry backs an insurance protection scheme that will bear the costs of replacing faulty ones.
Douglas Black, sales director for the Cumbernauld-based firm, said in the UK alone, sales of its safe, British-made products have grown 48 per cent as women seek to have faulty implants replaced.
He said: “What needs to come is cover for patients or clinicians to prevent this kind of scandal ever happening again. There is a possibility it would have been found out sooner if there was an implant registry and that has to come back too.”
According to the British Association of Aesthetic Plastic Surgeons (Baaps), a women with PIP implants face a 15-30 per cent chance they will need to be removed because the devices are “clearly substandard” and significantly more likely to rupture or leak silicone.
Black has also backed Baaps’ calls for the reinstatement of compulsory register for all implants after a previous register was disbanded in 2006.
Black said there needed to be increased regulation on implant manufacturers: “There are hundreds of manufacturers around the world and new ones popping up all the time.
“There are only two manufacturers of medical grade silicone; both are based in the USA. All ethical manufacturers should only be buying from these two companies.”
Nagor has two manufacturing sites, with another in Ashby de la Zouch. The firm employs more than 100 at its headquarters in Cumbernauld, which also hosts the firm’s research and development and regulatory functions.
In addition to breast implants, the company makes tissue expanders for reconstructive surgery, testicular implants, calf muscle implants, as well as providing “custom” fabrications.
In 2006, the firm was sold to American company Medicor which controlled 17 per cent of the breast implant market before going into chapter 11 bankruptcy in 2008. The firm’s assets, which included a French implant manufacturing business, were acquired by Dublin-based GC Aesthetics. In March, GC acquired a distributor in Brazil and revealed that its overall sales had reached $50m (£32.3m) a year in 90 countries.
Black said the PIP scandal was a “shock” and “horrible to see”. “The fact is that these women have a product inside them that hasn’t been tested and there still doesn’t seem to be a solution for these unfortunate patients.”
Nagor is three years through sponsoring a clinical trial to collect data on the long-term safety and performance of its gel-filled breast implants. More than 500 patients are participating in the UK study and are being followed for up to ten years.
Abbie Webb, 23, from Bristol, received free Nagor implants, part of a promotion that the company launched this year. So far 400 British victims of the PIP implants scandal have been given free or reduced cost implants by the firm. She said: “It makes a huge difference to me that my implants are British made. The fact that Nagor have helplines and all the implants have serial numbers added to that reassurance.”
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