UK: Breast implant failures threaten health of thousands

By Eileen Rose
25 January 2012

The ongoing scandal over PIP (Poly Implant Prostheses) breast implants makes clear the human cost of the privatisation of health care in the UK, and the callous indifference of the political elite towards its consequences.

The implants, produced by a now liquidated French company, were used on some 400,000 women worldwide for corrective surgery or breast augmentation. Criminally, the firm used industrial-grade silicone more suitable for use in mattresses than human beings.

Surgeons began raising concerns about the implants following a number of failures, resulting in inflammation and other complications in 2007. The following year, the Medicines and Healthcare products Regulatory Agency (MHRA) noted these concerns.

The faulty implants were withdrawn from Europe and South America last year, but more than 1,000 ruptures caused French Health officials to recommend in December that some 30,000 women in France should have the implants removed.

Eight cases of breast tumours had been found after removal of the faulty implants in France by the end of 2011, although the French authorities deny there is no concrete proof to link PIP with an increased risk of cancer.

Interpol listed Jean-Claude Mas, the 72-year-old founder of PIP, as wanted in connection to offenses concerning “life and health”.

But in Britain, where some 40,000 are estimated to have received the implants, the government continues to deny this is necessary, while many of the private clinics responsible are refusing to stand the costs.

In a cynical advertising campaign, the Conservative-Liberal Democrat coalition claims “there is no clear evidence” that the French-made implants threaten more harm than other brands. Posters to this effect are to appear in GPs’ surgeries and hospitals, as well as in newspapers and online.

This has been accompanied by the insinuation in sections of the media that many of the women involved have only themselves to blame by choosing “vanity” surgery.

This is a scurrilous accusation. It is not the operation that is responsible for the health threat, but the blatantly criminal actions of the corporation involved, and negligence on the part of the bodies supposed to regulate such products and procedures. Claims to the contrary are of a piece with claims that people should not be treated for supposedly “self-inflicted” diseases caused by obesity, smoking or alcohol.

The scandal has a clear class dimension. According to Reuters, lawyer Yves Haddad, acting for PIP, said that the company had sold two types of implants: A “high-end” product using the right silicone “for wealthier clients” and the “house gel” version, containing the unauthorised silicone, which was five times cheaper.

“Why did this company use this kind of product?,” he asked. “Because it was a corporation with economic objectives and because of corporate management that tried to get the best cost.”

Last year, it was reported that the PIP implants had been “rebranded” and sold by the Dutch company Rofil Medical under the name M-implant.

The UK government’s position has been contradicted by a joint statement from the Association of Breast Surgery, the plastic surgery associations and the Royal College of Surgeons, who urge that the implants should be removed free on request by the implant clinic.

Tim Goodacre, a member of the government-commissioned panel investigating the health scandal, said rupture rates were “very much higher” than was acceptable.

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said it also believes the implants should be removed as a precaution. “Although there is no immediate health risk, the gel within these implants is simply not meant to be inside the human body,” he said.

The advice now being given is that the clinic that did the surgery in the first place should carry out the procedure. If they refuse, and a woman can convince a doctor her health is at risk from the gel, or the implant has ruptured or leaked, the National Health Service (NHS) will remove the implant, but will not carry out the clearly necessary reconstruction.

This leaves many anxious women chasing clinics that may have gone out of business, or that are not returning calls. In instances where clinics have agreed to remove the implants, many women are forced to pay for reconstruction surgery.

Around 60 women protested in London’s Harley Street, calling on doctors to replace PIP breast implants for free. The women waved placards reading “Toxic Time Bombs” and “Health Before Wealth”.

Their protest targeted the Harley Medical Group, who installed nearly 14,000 implants, more than any other UK firm. The group claims it will be put out of business if it replaces the implants without charge. The demonstration also went to the office of Transform on New Cavendish Street, which has also said it will not replace implants without charge.

The Harley Medical group web site lists the criteria it uses to replace or remove ruptured and leaking implants. Ten years from insertion and with an MRI scan proving rupture and leakage, it will sanction free removal only; six years from insertion, free removal and replacement; and between six and ten years, replacement only at cost price. The company also says it does not have the staff or facilities to care for the 14,000 women it has treated.

Mel Braham, chairman of the Harley Medical Group, stated that the firm was “an innocent victim like everyone else” and that the MHRA was responsible for approving the implants. Braham argued that the NHS had a “moral duty” to remove the fault implants his company profited from inserting.

Sally Taber, director of the Independent Healthcare Advisory Services, also cited the failure of the MHRA. The Kitemark UK certification of reliability that the medical establishment relies on has been called into question over this scandal and others. There were 113 alerts issued by the MHRA last year about medical devices ranging from hip joints to surgical instruments. Brian Toft, professor of patient safety at Coventry University, said in September last year that CE marks (certification that the device reaches the European standards) were awarded on design specification but not on continuing checks on the manufacture of items.

The MHRA denies responsibility, saying that the company did not inform anyone about its use of in-house-manufactured industrial-grade gel. Richard Horton, editor of the Lancet, said MHRA’s approach seemed to be to do nothing “until something goes wrong”.

“Women should certainly be worried that regulatory procedures in place in the EU and UK have failed them so spectacularly”, he wrote.

Noting that private providers were responsible for 95 percent of all PIP implants, he pointed out that the government had no power to force them to take action. With the NHS increasingly penetrated by private capital, the scandal had shown “the future for the NHS. A system of health care that cannot be held accountable by the government; one that has no obligation to collect or supply accurate information about what it is doing; one that fiercely resists its duty of care to patients; and one that is more concerned with cost than it is with quality.”