Tag Archives: Breast implant

The PIP prosthesis lawsuit

17 May

It is not the first time in France that a lawsuit is intended on the basis of the bad quality of a health product.

The photograph shows grade IV capsular contrac...

The photograph shows grade IV capsular contracture in the right breast of a 29-year-old woman seven years after subglandular placement of 560cc silicone gel-filled breast implants. (Photo credit: Wikipedia)


Mastectomie (Photo credit: Wikipedia)

Figure of the anatomical position of a subglan...

Figure of the anatomical position of a subglandular breast implant. (Photo credit: Wikipedia)

Chest X-ray showing bilateral breast implants.

Chest X-ray showing bilateral breast implants. (Photo credit: Wikipedia)

We all remember the case of the Human Immunodeficiency Virus contaminated blood in the transfusion centers case. Now the lights of the actuality are focused on the Poly Implant Prosthèse, a brand of breast implants made in France. At the difference with the transfusion scandal where the French health services where solely implicated, in the PIP case, there are some intermediaries. Indeed those devices were guarantied by a Community European (CE) label and controlled, on behalf of the governments agencies by a private audit society, in that case a German certifying company called TÜV Rheinland Holding. Recently Dominique Maraninchi the director since February 2011 of the former Agence Française de Sécurité Sanitaire des Produits de Santé (French Agency for the Safety of Health Products AFSSAPS), now called since May 1st 2012 the Agence Nationale de Sécurité du Médicament et des Produits de Santé ( National Agency for the Safety of Medicines and Health Products ANSM), which, in parentheses, is not much easier to pronounce and far of the simplicity of the name of its American counterpart the FDA, said that (quoted): “Our oversight system isn’t adequate. It allowed a fraud of this size to take place for years. The system is based on certifying companies that check only what is presented to them”, end of quotation. It is interesting to notice that the Professor Maraninchi being a specialist in oncology has been at the head of the Regional Centre of Cancer of Marseille during 16 years and that the PIP prosthesis were for a large part implanted in the aftermath of breast cancer treatments. Thus we can think that the Professor Maraninchi has at heart that the cancer patients will be heard and exactly compensated be they victim of a PIP defective breast implant. It is also an other Doctor from Marseille, the plastic surgeon Christian Marinetti, who whistle blowed years ago against the particular fragility of the PIP implants.
So the less that we can say is that the responsibilities where diluted between the European Community label (CE), countries governmental agencies and the private certifying company. As the lawyers use to proceed pragmatically and knowing that PIP has just run into bankruptcy, guess whom they will attack first.

More content:






Implanted cardiovascular devices and PIP breast implants, what have they in common?

21 Jan

Reading Alain Braillon’s blog is very informative. In a recent article in the Archives of Internal Medicine dated from December 13th, 2010 he compares the approval processes of human body implanted devices in the US and in France.

The brachiocephalic veins, superior vena cava,...

Image via Wikipedia

By the way I learned that devices permanently implanted in the human body do not automatically require that they be authorized through a Pre Market Approval (PMA). In fact, in most of the cases, a Pre Market Notification (that means which do not require any evidence of the absence of adverse event nor data on efficacy) is sufficient for the Federal Drug Administration (FDA) to give its approval to market the device (which means implant it permanently or for several years in your body). If PIP are under your skin, cardiovascular devices can be implanted in your big vessels like the Inferior Vena Cava filters.

A study has shown that, between 2005 and 2009, 31 % of the devices recalled by FDA after commercialization because of serious health problems or even death were cardiovascular devices.

Read more:

Medical Devices Approval Process a New French Exception? Presse Médicale. 2011;40:446-8

Medical devices & the approval processes: United States vs France Archives of Internal Medicine. 2010;170:2040-1

HEALTH CARE REFORM; INVITED COMMENTARY; Medical Devices and the FDA Approval Process: Balancing Safety and Innovation. By Rita F. Redberg, MD, MSc, Editor.

PIP implants, a toxic affair

17 Jan

Breast implant fiasco

Mexican Breast Augmentation Deal

Image by permanently scatterbrained via Flickr

While the pip breast implants scandal spread worldwide, government reactions are contradictory. Czech, France and Germany counsel women to remove them even without rupture while Australia and the UK consider that there is no urge to remove them and that the PIP rupture rate is no higher than other brands and even in case of a rupture that PIP industrial silicone has not proven to be carcinogen. Depending on the country they are attached to, health authorities do not share the same message. Exactly like finance departments for the rescue of the Euro. And like for the Euro, a lack of regulation could bear the responsibility of the breast implant fiasco.

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