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 byPoly Implant Prothese (PIP), the FDA sent a firm warning letterdated 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 health ministry has advised 30,000 women in France with PIP silicone breast implants to have them removed, saying that while there is no proven cancer risk, the prostheses 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 silicone implants 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 health authorities.
“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.
Mike Pence credits president for ‘ceasefire’ solution to situation Trump created
Vice President Mike Pence delivered a five-day ceasefire with Turkey after President Donald Trump agreed to pull out American troops so Turkey could bomb the Kurdish people.
Thousands of people have been displaced, thousands have been killed or wounded as a result of Turkey's bombing campaign.
The United States was forced to bomb our own military base to prevent ISIS, Syria and Russian troops to have access to American military information and equipment. The Turkish bombing began so quickly that the American military couldn't conduct a withdrawal the proper way. American soldiers were also fired on so heavily that they almost fired back in self-defense.
Turkey quickly undermines Trump as he boasts about his deal-making: ‘This is not a ceasefire’
According to Turkey, President Donald Trump's so-called ceasefire in Syria isn't actually a ceasefire.
"Turkish FM Çavu?o?lu just now: 'We will suspend the Peace Spring operation for 120 hours for the PKK/YPG to withdraw. This is not a ceasefire,'" tweeted Turkey correspondent for The Economist.
According to Vice President Mike Pence, the ceasefire will take place for just five days. It's unclear what will happen after those five days are up.
CNN's Matt Hoye noted the Turkish foreign minister's comments came around the same time that Trump was praising the deal.
House Democrats: It’s time to include Trump’s shady Turkey deal in the impeachment inquiry
Even by Donald Trump's basement-level standards, there's something bizarre about the president's behavior in deciding to allow a Turkish invasion of Syria aimed at pushing the Kurdish population out of the area — a move that is, for all intents and purposes, an act of ethnic cleansing. Less than two weeks ago, Trump, apparently spontaneously, acceded to Turkish President Recep Tayyip Erdo?an's request that the U.S. pull a small number of troops out of the area to clear the way for what swiftly turned into a slaughter. Since then, Trump's attempts to justify this betrayal — not just of the Kurds, but of basic human decency — have been alarmingly erratic, well beyond his existing baseline of constant, impulsive dramatics.