The NHS Medical Director’s expert group published its final report today on the PIP Breast implant Scandal. Led by Professor Sir Bruce Keogh, they have gathered as much data as possible on rupture rates, clinical findings when implants are removed, and further investigation of the chemical make-up of PiP silicone gel.
PIP was a French company, run by Jean-Claude Mas, who was discovered to be using a cheaper, unapproved silicone gel, in the manufacture of implants for breast replacement and enhancement. The scandal broke at the end of 2011, and provoked a scare in the media affecting some 400,000 women who’d had the PIP implants. It was a shocking case, because many people trust their healthcare professionals to choose prosthetics for them, and manufacturers of medical products are hardly household brand names, rather they are assumed to be making a quality product that adheres to strict standards and guidelines.
As more information became available, the scandal spread to hip replacements and other manufacturers of medical devices, and it became apparent that almost any company could decide to make prosthetic devices, and offer them to the market, with little oversight and in some cases not even putting serial numbers on their products. The NHS Committee studying the PIP implants case looked at some quarter of a million implants given to 130,000 women in the UK, and studied around 5,600 removals to see what was discovered by surgeons.
In all, they announced some good and some worrying news. Firstly, the implants are not composed of gel that is considered carcinogenic or toxic, and they do not believe there is an immediate and present danger to anyone with the implants, in terms of the wrong substances used in their manufacture.
The implants do, however, have a higher rupture rate, around twice what would normally be expected. The rupture rate seems more to do with poor quality of manufacture, a mechanical issue, rather than to do with the wrong chemicals used.
Although the implants have a higher concentration of compounds, known as siloxanes, which are common in hair and skincare products and deodorants, they don’t particularly represent a health risk to women anymore than regular implants would.
Women who have suffered ruptures to their PIP implants have been seen to have swelling, and in some cases inflammation of lymph glands, but there is no evidence of an increased cancer risk as was originally touted in the media when the scandal broke some six months ago.
Recognizing that the implants did not contain proper medical grade silicon and understanding that the ramifications were the committee’s priority, because so many women had these questionable implants, and the anxiety caused by what seems somewhat exaggerated initial reports, represent a health risk in themselves.
Overall, the guidelines to women in the UK have not changed. If they are uncertain of the manufacturer of their implants, they should check with their surgeon or healthcare provider. Now that it is clear that the implants have a higher rupture rate, and some patients have been seen to have adverse reactions in the case of rupture, surgeon’s and clinics have the onus on them to take proactive steps to contact former patients and update them with the latest information.
To date 7,098 women have been referred to the NHS because of the implants. 4349 scans have been done and 490 women have had PIP implants removed on the NHS.
In light of the fact that the PIP problem is not an isolated case, Sir Bruce Keogh is currently undertaking a separate review of the wider system of regulation for cosmetic intervention.
Written by Rupert Shepherd