Wednesday, December 28, 2011

PIP Silicone Breast Implant Recall

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The French company Poly Implant Prothese, or PIP manufactured breast implants and supplied a large portion of the European breast implant market. The company was based in the south of France and for awhile was the number 3 breast implant producer in the world. 80% of production was exported out of France. While having undisclosed financial problems it began to cut costs by using a cheaper industrial grade silicone in the implants rather than medical grade silicone. This cut manufacturing costs by up to euro 1 million ($1.3 million) a year. A lawyer for the company told authorities that the switch to cheaper silicone began in 1991, shortly after the company began production. These implants were also marketed under the name M-implant by the company Rofil Medical in the Netherlands and distributed in Germany by the company Rofil Medro. Affected Rofil implants are designated as IMGHC-TX, MX-IMGHC, and IMGHC-LS.

The company was closed in 2010 after its improprieties were discovered following reports by surgeons of excessively high rupture rates and an anonymous letter denouncing company manufacturing processes but by then it had produced and sold over 300,000 implants worldwide including France (30,000), Portugal (2,000), Denmark (less than 100), Spain, Italy, Britain (40,000), Brazil (25,000), Venezuela, Australia (8,900), Chile, etc. Recent studies by the French authorities determined a rupture rate of 11.1% for PIP implants vs. 2% for other implants over the same time period. The durability of the PIP/Rofil implants is therefore substandard and the rupture rate is 5 to 6 times higher than other implants. This is particularly problematic given the use of industrial grade silicone which incites a greater inflammatory response from tissue than medial grade silicone. Between 2007 and 2009 50 to 58 percent of its exports went to South American countries including Venezuela, Brazil, Colombia and Argentina. In the same period, 27 to 28 percent of exports went to western European nations including Britain, Spain, Italy and Germany. These implants were never approved for use in the United States.

PIP saline-filled implants were available in the United States but the authorization was revoked after a re-evaluation by the Food and Drug Administration in 2000 found 11 deviations from ‘good manufacturing practices’ including PIP's failure to investigate the deflation of its saline implants and a failure to report more than 120 complaints in France and elsewhere to the FDA. 35,000 PIP saline implants had already been implanted in the US by that time. I suspect there were also some issues with the shell surrounding these implants as in the past when I held them in my hands the shells seemed flimsy.

More than 1,000 of the 30,000 such implants in France have burst, according to the French health safety agency AFSSAPS. It is now estimated that these implants have double the rupture rate of implants manufactured by other companies. In April 2010 Argentina, Colombia and Brazil banned importation of the implants. More than 2,000 legal complaints have been filed since the implants were recalled in 2010. The liquidation of the company and subsequent loss of company assets means the only remaining lawsuit defendants though are the surgeons who placed them or the government agencies that allowed their use. French authorities have advised all women with the implants to have them replaced but stated the removal was not urgent. They set up a hotline in France that received 9,500 calls between the end of November and December 2011. The French health ministry then advised women with PIP implants to have them removed as a precaution, cautioning that, while there was no proven cancer risk, they could rupture.

It is unclear yet if company founder Jean-Claude Mas will be charged but I suspect there is some jail time in his future. Interpol is currently has a warrant for his arrest. To my shock they even set up a cheaper industrial grade and more expensive medical grade silicone implant to differentiate between lower socioeconomic and higher socioeconomic customers. I suspect the French national health care system will cover removal of all of the implants but not for replacement of those placed for cosmetic reasons. I do not think they currently have the money or enough surgeons though to perform all of the resulting operations. Venezuela has already said it will remove the PIP implants at not cost to patients. They just have to show up at their nearest hospital with a Plastic Surgery ward. It is currently unclear what other Governments around Europe (Britain, Italy, Spain, Denmark..) will do. Given the group speak of Europe at present the other countries will have to fall in behind France's decision and since they also all have nationalized health care those governments will have to spend the money to remove the implants. Money which they do not have!

The Italian association of plastic surgeons is suing the Poly Implant Prothèse (PIP) company as well as TUV Rheinland, the German certification company that inspected these implants. The association states that their surgeons who placed these implants were misled by TUV Rheinland because their substandard inspection left the implants with the European Union's mark of approval.

The International Society for Aesthetic Plastic Surgery was informed by the German authorities at the BfArM Institute that the former company, GfE Medizintechnik GmbH, sold implants that were manufactured using PIP’s industrial-grade silicone gel under the name TiBREEZE between September 2003 and August 2004. These authorities now state that TiBREEZE implants should also be removed even in the absence of symptoms. Most of those implants were sold in Germany to about 280 patients. In addition, TiBREEZE implants were delivered to Belgium, Italy, Finland, South Africa, Switzerland, England, Austria, and Lichtenstein.

Several executives of the company are being sent to trial next year on charges of fraud that carry potential sentences of five years in jail. Names have not thus far been made public.

The World Health Organization has posted a webpage that links to the specific recommendations by national regulatory authorities of countries around the world listed by country with each posted in the native language of that country.

March 15, 2012 Addendum:
Dutch authorities today advised women who have PIP implants made before 2001 to have them removed because they may leak silicone that could harm their health. In the wake of PIP scandal Brazil authorities temporarily banned the import of all breast implants while they work out a testing process for imported breast implants.

April 20 , 2012 Addendum:
Ultrasound studies on 453 women who have PIP breast implsnts in place has shown that as many as one in three of the implants burst within 12 years of being implanted, some without outward physical signs of rupture. That would mean the PIP implants are 15 times more likely to rupture than non-PIP implants. Therefore one can only conclude that all of them should be removed before they become obviously symptomatic.

June 18, 2012 Addendum:
The final report of a review, led by Prof Sir Bruce Keogh, the NHS medical director, concluded PIP implants have double the rupture rate of other implants but the implant's gel material does not cause a long-term threat to human health and are not toxic nor carcinogenic. UK women who have symptoms of a rupture - for example tenderness, soreness or lumpiness - are advised to speak to their surgeon or GP.

Throughout the UK any women who had PIP implants fitted on the NHS can get them removed and replaced free of charge. In Wales the NHS will also replace those of private patients. In England and Scotland the NHS will remove implants of private patients but not replace them. They justify this by stating anxiety itself related to these implants is a form of health risk and thus it is entirely reasonable for women to have the right to opt for removal - regardless of whether there has been rupture. It sounds to me that there is more to this than they say but they do not want their regulatory agents to get into trouble.

    July 4, 2013 Addendum:
  • French, German, Dutch, Swedish and Czech Health Authorities advise removal of ALL PIP Breast implants regardless of whether they are intact or ruptured because the gel inside may have impurities that can cause problems if they rupture 
  • Most Governments offer free removal, but replacement implants must be paid for.
  • British Health Authorities say removal is not necessary if implants are intact. Ruptured implants to be removed free of charge by NHS, but replacement to be paid for.
  •  ISAPS (International Society of Aesthetic Plastic Surgeons) advises removal of ALL PIP implants regardless of rupture
  • IPRAS advises removal of all PIP implants regardless of rupture
October 8, 2013 Addendum:
  In France, nearly 15,000 women have chosen to have their implants removed or replaced. At least 4,000 reported PIP implants rupturing.

Mediapart reported that the AFSSAPS had learned of an increased risk of the implants rupturing in 2006.  That means the agency could have acted earlier than 2010 to take the implants off the market and prevented thousands more women having the implants.

The Harley Medical Group in London placed PIP implants in 13,900 women. The company could not afford to replace all of these implants, whose replacement was not covered by any liability insurance and many of these patients began legal proceedings against the Harley Medical Group. Fearing bankruptcy the company started a new firm to take over from the old firm in every capacity and let the old firm die off. The scandal is that the government agencies regulating licensing of these firms fast tracked the transition to a new company free of the liabilities of the old company. This is still ongoing.

November 14, 2013 Addendum:
A French court in Toulon ordered the German company TUV Rheinland to compensate victims of the PIP implants. The company granted European Union safety certificates for the implants. The company was ordered to pay 3,000 euros to each of the victims because it "failed its obligation of checking, caution and vigilance". Experts will review each case and some victims may get more money if their case warrants it. Total claims against the company by victims and distributors is $71.4 million. Lawyers' for the company defense was the company only approved the manufacturing process not the final product. If you have had a PIP implant you should try to become a member of this class action law suit.

Aaron Stone MD - twitter
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