U.S. warned French breast implant maker 10 YEARS before silicone scandal brokePIP”s saline devices described as “adulterated”U.S. health authorities issued warning in 2000Firm”s silicone implants already under investigationThousands more women could be affected
Burst: Defective silicone gel breast implants, from French firm PIP, which were removed from a patient
The French breast implant maker at the heart of a worldwide scandal was warned about the quality of its products more than 10 years ago, it emerged today.
Poly Implant Prothese (PIP) was told in 2000 that its saline implants were “adulterated” – a decade before it came under scrutiny from European regulators for its silicone implants.
More than 300,000 women who received the company”s silicone implants, which were ordered off the market in 2010, have already been told they are at risk.
And now thousands more women who received its saline implants are facing potential safety issues.
But it is not yet known how many received the implant or whether indeed they are unsafe.
The U.S. Food and Drug Administration inspected the firm”s La Seyne Sur Mer plant, used to produce silicone and saline implants, in 2000.
In a warning letter to company founder Jean-Claude Mas it said there were 11 deviations from “good manufacturing practices”.
Dated June 22, 2000, it cited 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.
Threat: The “low quality” PIP implants contained industrial silicone – designed for computers and electronic devices – instead of medical-grade fillers
It also said the plant did not havea process in place to make sure the saline implants it produced met design specifications.
The revelation has led to questions as to why the warning did not prompt a larger investigation by French authorities.
PIP began selling its saline implants in the U.S. in September 1996 under a system that did not require the company to submit clinical trials to show an implant”s safety and effectiveness.
THE GREAT SILICONE IMPLANT SCANDAL
PIP – once the third-largest maker of breast implants in the world – stands accused of using industrial-grade silicone in some of its implants.
There are fears that the implants, which were sold around the world, could cause health problems if they burst or leak.
It has affected 40,000 British women and 300,000 worldwide.
The French government has urged the 30,000 women in France with PIP implants to have them removed – and offered to pay for the surgery.
Other countries, including Britain, have only gone as far as saying that women should visit their surgeons for checks.
Concerns about their safety first surfaced 18 months ago, when surgeons noticed they were rupturing much more quickly than other brands.
The French health watchdog ordered an inquiry, which subsequently reported ‘serious irregularities’ in the implants and they were pulled off the market.
Manufacturers were accused of fraudulently using a non-approved silicone gel for almost 10 years which believed to have been originally designed for mattresses.
They have a higher than normal rupture rate – up to five per cent among French women – and have been linked to the death of a French woman from a rare form of cancer called anaplastic large cell lymphoma (ALCL), and implicated in at least seven other cancer cases.
It has also emerged many of the implants were missing a protective coating designed to stop them from splitting and prevent any gel that leaked from spreading through the body.
It was feared that leaked gel could trigger cancer but to date tests have remained inconclusive.
About 300,000 PIP implants were sold worldwide before the company went into administration last year.
This was as long as it was “substantially equivalent” to devices already on the market.
The French company could not sell its silicone-gel implants in the U.S. at the time because the FDA had prohibited the sale of all such implants from 1992 until 2006 for most women because of safety concerns.
But, for many years, the FDA allowed manufacturers to sell saline implants without formal safety trials.
This was because many were sold before the agency received the authority to regulate medical devices. The agency assumed they were safe unless proven otherwise.
In 2000, due to concerns about possible complications such as infections and rupturing, the agency finally required all implant companies to submit a formal application, known as pre-market approval, to continue selling their products.
PIP was one of three companies that submitted an application, which came under review of a panel of outside advisors to the FDA in March 2000.
At the time, PIP said it had already sold 35,000 of its pre-filled saline implants in the U.S., and that it was the third-largest manufacturer of breast implants in the world.
It said it only had reports of 521 complaints with its devices, a rate of 1.5 per cent.
But the panel recommended that the FDA reject PIP”s application.
It recommended the implants from the other two companies, Inamed Inc, now part of Allergan Inc and Mentor, now a unit of Johnson & Johnson.
Panellists said at the time they were not reassured by PIP”s data, and that the company”s clinical trials did not include enough patients that were followed for an adequate time to truly evaluate the device”s risks.
One panel member, Boyd Burkhardt, a plastic surgeon from Arizona, said the company”s data was incomplete, and he found it difficult to understand why the company was “as ill prepared as you appear to be” to meet regulatory standards.
He told the firm: “Like it or not, we have a regulatory threshold which is probably higher or at least different than it is elsewhere in the world, and I think in order to get your product approved, you”re just going to have to bite your tongue and meet that threshold.”
Asked to comment on the PIP controversy, Burkhardt, in a brief interview, said that he stands by the prior comments he made to the FDA.
It was not immediately clear why after the rejection, the FDA then carried out an inspection of the PIP plant in May 2000.
PIP said it stopped selling its saline implants, which usually contain a silicone outer shell filled with a sterile saltwater (saline) solution, in the United States that same month.
Owner: PIP President Jean-Claude Mas, who was warned about the implants his firm was selling
