Wednesday 5 June 2013

PIP RESEARCH

ABOUT PIP

 
The PIP breast implants that were fraudulently filled with industrial-grade silicone may have caused their recipients harm
 
 
 
 
Poly Implant Prothèse (PIP) was a French company started in 1991 that produced breast implants. It was founded by the Frenchman Jean-Claude Mas, born in 1939, a former medical sales representative for the Bristol Myers company for 15 years. PIP went into liquidation in 2011. The company and its founder are at the heart of a public-health care scandal.

The company produced circa 100 000 implants per year, during circa 20 years. Approximately 400,000 women worldwide may have PIP gel implant products implanted to enhance breast size or correct for tissue loss. The implants have been exported to Latin American countries such as Brazil, Venezuela and Argentina, Western European markets including Britain (25 000), Germany, Spain and Italy, as well as Australia (8900).

Mas teamed up with plastic surgeon Henri Arion, who introduced breast implants to France in 1965
 

TIME LINE


2000: Implant sales in USA halted by an FDA launched moratorium on silicone implants.

2001: PIP began to use unapproved in-house manufactured industrial-grade instead of medical-grade silicone in the majority of its implants.

2003: the first signs of legal problems and financial losses can be traced by regulatory filings.

2009: Concerns surfaced in France first in 2009 when surgeons started reporting an abnormally high rupture rates. Which resulted in a flood of legal complaints and the company's bankruptcy.

2010: TÜV Rheinland, headquartered in Germany, gave a quality certificate to the production process used by the company until March 2010. However, this didn't apply to the type of silicone used.
A former PIP worker and union chief, Eric Mariaccia said "You had to have been a chemist to have noticed anything,". He also said that "The responsible ones aren't the workers but the heads of the company, notably the four who were linked to production and thus responsible for their quality,".
2010: In March 2010 PIP was placed into liquidation with losses of 9 million EUR after the French medical safety agency recalled its implants. In a subsequent inspection of the manufacturing site, the company was found to use unapproved industrial-grade, silicone, with a cost of only 10% of an approved gel.

2011: On December 20 French officials say that an action plan is underway following the death of a woman from ALCL. The French government recommended on December 23, 2011 that 30 000 women in France seek removal of breast implants made of a suspect silicone gel by the worldwide exporting PIP firm


IMPACT IN:

FRANCE


The French government recommended per December 23, 2011 that 30 000 women in France seek removal of breast implants made by PIP. For women that want to keep their implants, the state will pay for a 6-monthly ultrasound scan.

French public health care funds will be used to finance the recommended implant removals, at a cost estimated at 60 million EUR. New implants will be paid for in cases where they were used initially for medical reasons, others will need to finance a new implant by themselves. Associations representing women with PIP implants demand that public funds cover all cases. "This announcement is just a smokescreen and the victims of PIP are angry," says Alexandra Blachere, head of the association of PIP implant users in France.

A government hotline has been set up by December 2011


UK


In Britain, there's an estimated 30 000 - 40 000 begin_of_the_skype_highlighting affected women. The chief Medical Officer Dame Sally Davies says: "Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon.". Removing the implant "carries risks in itself," she also said.

Concerns was filed with the The UK MHRA in 2009 when a lump was found during a mammogram and ultrasound scan in a female patients breast but no action was taken by MHRA at the time.
Shadow Health Secretary Andy Burnham said private clinics in Britain that fitted PIP implants must be forced to pick up the cost of removing them.

On 6 January 2012 the British Health ministry will offer examinations and possible removal - in instances where a doctor says it's necessary. And called on private medical centers to offer the same deal to patients who had paid for private sector cosmetic surgery

LATIN AND SOUTH AMERICA

  • Costa Rica - breast implants banned and taken off the market in March 2010
  • Brazil - banned the breast implants on 30 Dec 2011, taken off the market in 2010
  • Bolivia - implants replaced free of charge for some women on 29 Dec 2011
  • Venezuela - promised to remove them free of charge
  • Ecuador - sales banned on 29 Dec 2011
  • Argentina - ban
  • Chile - ban
  • Colombia - ban


  • www.wikipedia.org

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