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.
Republican staffer caught spying on Democrats during Judiciary Committee meetings
A Republican staffer from the Ways and Means committee was caught spying on Democrats during their work over the weekend.
According to a Judiciary Committee source, the female staffer was ultimately discovered and ran out of the committee room once it was discovered she was there, tweeted Olivia Beavers, a writer at "The Hill."
"A Judiciary source says the committee, which has been practicing for their Monday impeachment hearing this whole weekend, came across a female GOP Ways and Means staffer in the hearing room today, but that she ran out once discovered," she tweeted.
New York Times editorial board asks Trump if he didn’t do anything wrong — why he won’t let witnesses testify
The New York Times editorial board issued a scathing op-ed Sunday detailing the ways in which President Donald Trump is destroying one of the key branches of the United States government.
While many presidents battle with Congress, Trump has taken his "obvious contempt" to a whole new level. But if he was truly innocent of the accusations he's facing, then why is he hiding so much.
"If Mr. Trump is so clear in his own mind that he didn’t try to pressure the Ukrainian government to interfere in the 2020 election, why won’t he send the secretary of state, Mike Pompeo, to testify under oath that there was no quid pro quo?" asked The Times. "Instead, he has issued a blanket refusal to allow officials of his administration to testify or submit documents demanded by Congress. His approach is pitting Republican House members’ fealty to him against their respect for their own institution. They are making a fateful choice to diminish the House."
Former Republican Congressman admits he ‘can’t explain’ Ted Cruz: ‘You’d think he’d have more self-respect’
Sen. Ted Cruz (R-TX) appeared on "Meet the Press" Sunday to perpetuate the false narrative that Ukraine hacked the 2016 election, a fact that has been disproven by all of the U.S. intelligence agencies. When asked to explain what Cruz could possibly have been thinking, former Rep. Charlie Dent (R-PA) confessed he has no idea how to explain Cruz.
"So, Charlie, what's going on here?" asked CNN host Fredricka Whitfield.