Breast implant safety

There is a blame game being conducted in the world’s media at the moment regarding specific breast implants from France.

The French company at the centre of the concern was warned by US health authorities more than 10 years ago about the substandard manufacturing practices- Kathryn Borg

This constant reporting is doing nothing to help the women who have either paid to have implants, or have received them through a national health system.

Preliminary reports suggest that these implants may be prone to rupture and leakage.

However, the real concern is that nobody seems to know the full extent of the risks due to the fact that the silicone used in the implants has never been tested for human use.

The French company at the centre of the concern was warned by US health authorities more than 10 years ago about substandard manufacturing practices, something that has been revealed in latest reports.

The company was issued a warning letter by the US Food and Drug Administration (FDA) in June 2000 following an inspection of a plant run by the manufacturer in south-eastern France.

The FDA had said the saline implants being made at the plant were “adulterated”, referring to “the methods used in, or the facilities or controls used for, manufacturing, packing, storage or installation, are not in conformance with Good Manufacturing Practice for Medical Devices Regulation”.

Some of the specific violations identified in the letter included failing to report any complaints related to saline implants to the FDA, failing to have procedures in place to analyse data from defective implants and failing to ensure that all staff were adequately trained.

Due to these violations, the FDA said it would be detaining all implants imported into the US from this company until permanent corrective actions were taken.

These warnings related to the saline implants, and not the silicone ones which were the reason for worldwide alarm, despite the fact that the plant inspected by the FDA was responsible for producing both types of implant.

The question now being asked is why this warning and inspection did not trigger further scrutiny of the company’s methods by regulators in France and elsewhere in Europe.

The letter was made public in 2000; however the French health authority Agence Francaise de Secrurite Sanitaire des Produits de Sante (French Agency for the Safety of Health Products) has said that it had not been informed of the warning’s existence.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) first noted concerns regarding the implants in 2008, but it wasn’t until 2010 that they issued a ‘Medical Device Alert’ on the products, thereby advising UK clinicians not to implant them and commissioned testing to evaluate the implants’ safety.

As early as 2006, surgeons had begun publically reporting their own anxieties about the implants, yet no action was taken by the MHRA.

Richard Horton, editor in chief of the medical journal The Lancet, asked in a recent editorial whether the MHRA had read one such report which spoke of a “massive failure” involving a three-year-old implant.

Horton criticised the reaction of the MHRA to a report regarding the migration of the silicone, stating that “if the MHRA did not read this report, what is the point of an agency that does not keep up with safety signals reported in medical literature?”

He went on to ask if it did read the report then why was action not taken sooner.

Horton criticised the MHRA’s reaction to France’s December 2011 decision to advise women to have the implants removed. He said the decision not to follow suit was “hasty, cavalier, and completely counter to ongoing concerns about the implants”.

This year the UK government has agreed that those who received these implants through the NHS can have them replaced by the NHS. However, those who used private clinics would have to consult their clinics, which would have to offer the same deal to their clients.

Of course, the clinics have refused to replace the implants free of charge. One clinic said it had fitted nearly 14,000 women with these implants between September 2001 and March 2010 and did not have the resources, the surgeons or the operating facilities to offer this service. This clinic felt the government had a “moral responsibility” to replace the implants.

This argument has been discussed at length on radio, television and in the media.

Others feel that if a woman has paid, privately, for this service it is up to them to find a solution as it was, effectively, cosmetic surgery and not essentially required. Those who were treated on the NHS were generally treated because of a medical condition and therefore were exempt from this argument.

The clinics have blamed the regulatory authorities; in fact, everyone is playing the blame game in this unfortunate situation. The MHRA has said the manufacturer gave the products a European Conformity (CE) mark, indicating that it complied with the relevant EU regulations.

Once a medical device has a CE mark it can be placed on the market in any EU member state.

This then removes the blame from the MHRA and places it on the EU combination of a regulatory failure in France and the EU laws that prevent British (and other) authorities from protecting consumers, as the CE mark is supposed to provide a guarantee of quality. European law then forbids the MHRA from conducting further checks.

Whoever is to blame, the situation highlights the gaping holes in the double safety net which is supposed to protect Europe.

Clearly tighter controls are required to avoid such situations in the future.

kathryn@maltanet.net