Checks ‘could have prevented’ PIP breast implant scandal

The admission comes following an independent review into the cosmetics industry as a result of the breast implant controversy which affected tens of thousands of women in the UK.

These new recommendations to the government, regulators and professionals aim to ensure health and safety is put ahead of commercial interest.

‘Data-free zone’

Chairing the review was the NHS medical director Professor Sir Bruce Keogh: “This is a pretty data-free zone – with the PIP implants, not only did organisations implanting not really keep a good record of what they had done, they didn’t have a record of the outcomes either.

“The most important thing in my mind (is) it meant that we had a faulty product on the market and we had no way of tracing the women who had PIP implants to notify them they might be carrying a troublesome implant.”

The implants were manufactured by French company Poly Implant Prothese (PIP). They were filled with non-medical grade silicone intended for use in mattresses, and have been linked to rupture and swelling in the body.

Health experts say the implants should not cause any long-term problems and the gel materials used inside the implants are not toxic or carcinogenic.

No redress

Catherine Kydd, whose PIP implants ruptured and leaked into her lymph nodes, said that the industry “must be regulated and people should have redress”.

The 40-year-old, from Dartford, Kent, said: “I had surgery in 2004. I went back to complain that my left breast felt like it was slipping round into my back and that it was painful but the surgeon told me it was fine.

“In 2009 I went to the GP and they sent me straight for a scan. They told me that it was not cancer but my left implant had ruptured. I was left in the radiologist’s office and didn’t know what to do. I had no redress, I had nowhere to go.

“Why is it acceptable that I have to live with industrial silicone in my lymph nodes for the rest of my life due to this industry that is not properly regulated? This pen is more regulated than my breast implant.”

“Woeful lapses”

The review highlighted that there were “woeful lapses” in implant quality, after care and record keeping and that there is still widespread use of misleading advertising, inappropriate marketing and unsafe practices right across the sector.

Sir Bruce added that the way incentives are used in the cosmetics industry is particularly distasteful: “People winning cosmetic procedures as part of a raffle or as a prize at some dinner, the buy one get one free or the time limited deals – the sign up this lunch time and get a reduced price or so forth.

“These kinds of things we found really difficult ethically.”

New recommendations

The board has recommended that all people who perform plastic surgery in the UK should be on a register; there should be unannounced inspections on manufacturing plants, and that anyone who has surgery should be properly protected suggesting an ABTA-style risk pool for when things go wrong or when companies go out of business.

The boom in the use of dermal filler injections was also cause for concern and was described as a “crisis waiting to happen”.

Current legislation means that anyone can set themselves up as a practitioner with no training or previous experience and there has been an explosive growth in the market driven by high demand and high profits.

Recommendations have been made to classify fillers as a prescription only medical device and that only people with appropriate accreditation can administer them. Practitioners should also be required to show their credentials before carrying out surgical and non surgical procedures on patients.