US warned French implant maker as far back as 2000

December 28, 2011 in Other

The US Food and Drug Administration warned a French maker of breast implants now feared to be at risk of rupture of "serious" quality control violations involving saline implants back in 2000.

Following a May 2000 inspection of a factory in France operated by Poly Implant Prothese (PIP), the FDA sent a firm warning letter dated June 22, 2000, warning saline implants made at that facility were "adulterated."

The letter, seen by AFP, outlines a list of quality assurance problems the FDA warned "may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems."

The company is currently under scrutiny not for its saline implants, but for its silicone implants. PIP is suspected of fraudulently using a poor-quality gel for those devices which is linked to leakage and inflammation problems.

France's has advised 30,000 women in France with PIP silicone breast implants to have them removed, saying that while there is no proven , the could rupture.

Prosecutors in Marseille, near PIP's home base of La-Seyne-sur-Mer, have received more than 2,000 complaints from Frenchwomen who received the silicone implants, and have opened a criminal investigation into the firm.

Documents obtained by AFP showed tens of thousands of women in more than 65 countries, mainly in South America and western Europe, received produced by PIP.

An FDA spokeswoman said Tuesday she could not confirm if the results of the May 2000 inspection were also relayed to French .

"Our warning letter was publicly available in 2000. Given the timeframe, I haven't been able to confirm whether any information was shared with France," said the spokeswoman, Erica Jefferson.

But "generally speaking, when the FDA conducts inspections in foreign countries of foreign facilities, they are aware of our presence in country," she added.

(c) 2011 AFP

send feedback to editors
5 /5 (1 vote)  

Filter


Move the slider to adjust rank threshold, so that you can hide some of the comments.


Display comments: newest first

Squirrel
Dec 28, 2011

Rank: not rated yet
What one feared. It was not about silicone itself but about manufacturing irregularities of which the silicone is but one--and now very known--example. Goodness knows what other production cost cutting short cuts were taken. Why didn't the France authorities react--what else were they told and kept silent? What other "warning letters" are "publicly available" but buried away "conveniently" forgotten?
Rank 5 /5 (1 vote)
Tags

silicone implants, saline implants, food and drug administration, health authorities, cancer risk, health ministry, prostheses, criminal investigation, silicone breast implants
Related Stories
more news
Relevant PhysicsForums posts

More news stories

Flesh-eating disease victim gets prosthetic hands

(AP)—A woman who lost both hands, her left leg and right foot after contracting a flesh-eating disease has been fitted with prosthetic hands.

Other created May 18, 2013 | popularity not rated yet | comments 0

Illinois Senate approves medical marijuana bill

(AP)—Medical marijuana use in Illinois is now in Gov. Pat Quinn's hands after the state Senate approved legislation.

Other created May 17, 2013 | popularity 5 / 5 (1) | comments 0

Nigerian court jails two over killer teething drug

A Nigerian court on Friday sentenced two officials from a pharmaceutical company to seven years in prison over the sale of an adulterated teething drug which killed 84 babies in 2008.

Other created May 17, 2013 | popularity not rated yet | comments 0

Many patients would switch doc to cut health care costs

(HealthDay)—Many Americans feel that keeping out-of-pocket health care costs is more important than staying with the same primary care physician.

Other created May 17, 2013 | popularity not rated yet | comments 0

Cultural attitudes impede organ donations in China

(AP)—China is phasing out its reliance on executed prisoners for donated organs, but an architect of the country's transplant system said Friday that ingrained cultural attitudes are impeding the rise of ...

Other created May 17, 2013 | popularity not rated yet | comments 0


Alzheimer's leaves bilingual victims stranded in Canada

The devastating effect of Alzheimer's disease on bilingual people has been thrown into focus in Canada, where the sudden loss of a second language can leave sufferers feeling like strangers in their own country.

'Gap' for HIV vaccine efforts after latest setback

The hunt for an HIV vaccine has gobbled up $8 billion in the past decade, and the failure of the most recent efficacy trial has delivered yet another setback to 26 years of efforts.

Consuming coffee linked to lower risk of detrimental liver disease, study finds

Regular consumption of coffee is associated with a reduced risk of primary sclerosing cholangitis (PSC), an autoimmune liver disease, Mayo Clinic research shows. The findings were being presented at the Digestive Disease ...

Ketamine shows significant therapeutic benefit in people with treatment-resistant depression

Patients with treatment-resistant major depression saw dramatic improvement in their illness after treatment with ketamine, an anesthetic, according to the largest ketamine clinical trial to-date led by researchers from the ...

Research examines new methods for managing digestive health

Research presented at Digestive Disease Week (DDW) explores new methods for managing digestive health through diet and lifestyle.

New smartphone application improves colonoscopy preparation

The use of a smartphone application significantly improves patients' preparation for a colonoscopy, according to new research presented today at Digestive Disease Week (DDW). The preparation process, which begins days in ...