It’s a two year old story now, but hitting the headlines again, as these things tend to, because of the news that the French government has recommended preventative removal of implants and even agreed to pay for the procedure. One has to assume they wouldn’t be doing this unless they were pretty convinced that taking the pain today is better than doing nothing and facing legal claims from 30,000 french women tomorrow. In an attempt to get under the skin of the tabloid news headlines we speculate about whether regulatory controls are tight enough when a company can substitute “mattress grade” silicone for that which was approved in the regulatory process.
Poly Implant Prothese (PIP) is (was) a French manufacturer of Silicone Breast Implants so well known that implantees often spoke about their “PIP”s and recommended them to friends. Silicone Implants have been the subject of controversy for many years and indeed were banned in USA for 14 years before a lack of evidence that they were problematic saw the ban removed in 2006. They have been under the microscope for years and remain the implant of choice today.
The specific circumstances in this case are that the implants manufactured by PIP since 2005 (subsequently withdrawn by French regulators in 2010) differed in two key respects from the product originally CE marked. Firstly the company dispensed with the protective outer skin and secondly they replaced the silicone contents that had featured in the approved product with a lower grade of material, dubbed “mattress grade” in the popular press. The savings to the manufacturer are variously estimated at up to €1M.
Of the 30,000 women in France who received PIP implants since 2001 there have been 1,000 reports of implant rupture. Remember the changes were made in 2005 which may suggest that the rupture rate in the affected batches is actually higher, assuming there is a lower incidence in the original design (we don’t have this information yet).
Contrastingly in other markets (including UK and Australia) the rupture rate is five times lower, even though numbers are actually higher (40-50,000 in UK) which is curious and seemingly must mean French surgery is in some way five times more likely to result in a leaky implant (rather unlikely) or that reporting is done differently. It does seem there may be a hidden problem evolving as anecdotal evidence of problems gathers pace.
Competent Authorities in discussion
On Wednesday many European Competent Authorities(CA), the government bodies ultimately responsible for health regulatory matters in each country, got their heads together and agreed that the problem was five times worse in France than anywhere else (ie 5% problem rate vs 1% in many other countries). They concluded that at the present time they saw no evidence of a disproportionate rupture rate other than in France, but did recommend patients should make an appointment with their implanting surgeon for a discussion and presumably examination. They rather ominously hedged their bets by saying their “experts will be looking carefully at the French safety statement when it comes out as a matter of priority and issue further advice as necessary.” So expect the story to come back again soon.
Back in 2010, following the original Medical Device Alert issued by UK CA the MHRA, the British Association for Aesthetic Plastic Surgery (BAAPS) issued a statement recommending patients should book in for exploratory ultrasound assessment of their implants. The organisation has now updated it’s guidance with a new press release, the content of which includes the statement; “The message here is not to panic – our main advice remains unchanged. Women with PIP implants should be checked by the clinic where they had their surgery and can then be monitored afterwards. These implants have a higher failure rate so there will be women who might choose to have their implants removed before that happens, whereas others will be happy to be monitored.”
But putting our medtech hat on for a moment we go back to the first press release issued in June 2010; “This comprehensive study concludes this situation is clearly not the fault of the surgeon, who acted in good faith – it would be similar to blaming a dealership for a faulty car. There was no way of knowing the gel was untested or that the protective envelope, which adds strength and restricts the gel from travelling into the body, had been dispensed with.”
Where’s the balance here? Should a clinician always trust a CE mark? Is it really good enough to assume that a product has passed regulatory muster therefore requires no further questioning? Using the car analogy, would you buy a car without finding out its key attributes? No regulatory authority in any industry has perfect judgment, and always relies to some extent on customer power as its ultimate filter. And if it’s really being suggested that clinicians don’t ask key questions of suppliers then our years of sitting across tables from clinicians who are absolutely superb judges of what’s important in a product (and don’t mind adopting a hard line in questioning in the interest of their patient and practice) must have been a dream.
Regulatory control adequacy?
At the other end of the argument, shouldn’t regulatory controls mean clinicians should be able to relax about product choice and get on with the therapy?
It’s admittedly a minefield, but experience would suggest that if you’re a clinician it’s definitely your call to decide whether you judge a product to be safe or not. It sounds harsh, but it’s not enough to rely on a regulatory approval. And if you’re honest you know that because you’re a cautious bunch normally relying on armfuls of peer reviewed clinical study data from prospective randomised multicentre studies before you adopt a new technology.
This one’s crept under the radar because the product changed over the years, so who wouldn’t assume it was safe and effective?
But at the heart of the issue here is the regulatory control. How can a company make such a fundamental change-in fact two fundamental changes-without it being picked up in regulatory audits by notified bodies which occur every year. What kind of an audit misses that?
Footnote 1: These implants were not FDA approved and never available in US. If ever we need an argument for more rather than less tight regulation I’m afraid this might be it.
Footnote 2: There’s no doubt a case to be answered by the executives of the manufacturer.
Footnote 3: This may be a salutory lesson in how clinician choice must prevail over short term financial precedence. Smart clinicians will be sitting in front of purchasing committees armed with a prime example of how cheapness doesn’t always mean economic sense.
Source: medlatest staff