March 20 (Bloomberg) -- Annie Mesnil survived cancer, only to have the implant that replaced her right breast leak industrial-grade gel into her body. Now European regulators are trying to figure out how to make sure it doesn’t happen again.
Employees of the manufacturer of the faulty device, Poly Implant Prothese SA of France, have told police they used unapproved filler and deceived the company hired to certify quality control. French authorities pulled the devices from the market in 2010 and last year recommended that all PIP implants should be removed after a woman died in November.
Doctors and patients like Mesnil are pushing European Union regulators to revamp rules that leave medical-device makers in charge of checking the safety of their own products. The companies are required to hire outside contractors to certify quality controls and production systems before they can sell devices throughout the 27-nation bloc and in countries that recognize its standards. About 400,000 PIP implants were sold in nations including Australia, Brazil, Germany and the U.K.
“Our oversight system isn’t adequate,” Dominique Maraninchi, director general of Afssaps, France’s health industry regulator, said in an interview. “It allowed a fraud of this size to take place for years. The system is based on certifying companies that check only what is presented to them. With PIP they were fooled, the health authorities were fooled.”
What Went Wrong
Reports on what went wrong and how to avoid recurrences have started arriving as Afssaps works on a list of high-risk implants and how to better police their safety with a new surveillance system due later this year. Another report is due next month on the state of the silicone breast-implant industry, a decade after it was authorized in France, a spokeswoman for the agency said.
French health inspectors suspended PIP operations on March 29, 2010. The company filed for bankruptcy the next day and health authorities around the world were told of the deception.
“According to Afssaps, there was no reason to worry so much,” Mesnil, a 62-year-old grandmother who had an implant in 2001 after treatments for breast cancer, said of the first alerts she saw in 2010. “They didn’t speak of any danger certainly, just a little more frequent rupture rate.”
As the police investigated and evidence emerged of the deception, Mesnil said she began worrying both about the safety of her implant and why complaints from surgeons in France, the high rupture rate, and the U.S. regulator’s refusal to approve the devices didn’t lead to greater scrutiny by Afssaps.
“The system failed,” said Christian Marinetti, a Marseille plastic surgeon who said his calls, e-mails and registered letters to Afssaps about PIP’s high rupture rate went unanswered for years. The problem, he said, is “the checks assume the company is virtuous. No one ever could have imagined such a fraud.”
In 14 percent of the women in France whose implants were removed, the device was found to have ruptured or leaked, officials said.
Afssaps, which uncovered the scam after a whistle-blower’s alert, pledged in a report to reinforce oversight with surprise inspections, tests of devices taken during audits and from clinics, checks on how much manufacturers spend on raw materials, and a simpler, more efficient means for doctors to report concerns.
Afssaps also called for its recommendations to be applied EU-wide in the 170-page report to Health Minister Xavier Bertrand last month. Clinical trials should be required for devices to be approved and there should be follow-up tests after they’re on the market, the French regulator said. Patients should be better informed of devices’ risks before operations, and certification companies should be more exacting. Regulators within the EU and around the world should improve information-sharing and collaboration, Afssaps said.
At the EU level, Health Commissioner John Dalli ordered stress tests -- similar to those used to gauge banks’ fiscal health -- to see how the regulatory system failed to detect PIP’s deception. The results are expected by May so they can be incorporated into a new regulatory framework due out by June, said Frederic Vincent, a spokesman for Dalli.
“There are some propositions that are being discussed at the European Commission level, in order to coordinate how the oversight system should work and, going one step further, what the obligations should be in terms of in-depth clinical data gathering before risky devices are put on the market,” Afssaps’s Maraninchi said.
PIP hired TUEV Rheinland Holding AG, a German technical certification company, to audit the chain of production and quality-control measures, Olivier Gutkes, TUEV’s Paris-based lawyer, said last month.
TUEV’s job “isn’t to check the final product,” Gutkes said. “It’s about avoiding having unsuitable products because of disorganization or production errors.”
Jean-Claude Mas, 72, PIP’s founder, began using industrial-grade silicone years ago, according to police, cutting the cost of the filling to as little as 5.10 euros ($6.67) a kilogram from the 41.54 euros a kilogram for the substance he claimed was used. He also used thinner casing, making ruptures and leaks more likely and heightening the risk posed by the cheaper silicone, never authorized for use inside people, said Marinetti, the surgeon.
Mas didn’t return messages left on his mobile phone requesting comment. His lawyer, Yves Haddad, didn’t respond to requests for comment by phone, e-mail and fax.
Mas, who previously worked as a wine and cognac seller and spent 10 years with U.S. drugmaker Bristol-Myers Squibb Co., will stand trial for fraud with four former co-workers later this year or in early 2013. Police are investigating manslaughter claims made after the woman’s death and allegations that PIP’s bankruptcy was a sham.
Almost all PIP employees knew most devices were filled with an unapproved gel, which Mas always insisted was “better” than the authorized one, according to transcripts of police interviews with Mas and other workers seen by Bloomberg News.
PIP workers hid barrels of the unauthorized substitute in a separate warehouse and on a truck when TUEV certifiers visited for their annual audits, former employees told investigators, according to the transcripts. Another said he was asked to erase evidence of the unapproved substances from the computer system before the audits and to reintegrate the data afterwards.
Each year, after TUEV auditors left, workers celebrated with drinks, according to another former PIP employee.
TUEV has accused PIP of fraud and doctoring documents in its own complaint, and defended its conduct as complying with the existing rules “to the letter,” said Gutkes. It hasn’t and won’t change its practices until those rules change, the TUEV lawyer said.
‘No One Imagined’
“An unannounced audit is carried out only in one case: when the notified body has doubts about a fraud which can be substantiated,” Gutkes said. “No one at TUEV ever imagined that the whole company was involved in covering up the fraud.”
Mas himself repeatedly told police he felt “nothing” for women like Mesnil who found themselves in danger because of PIP’s implants, saying the women who complained were “weak people” or “doing this just for the cash,” according to the transcripts.
Mesnil heard similar comments at first, as people said “they should have stayed like they were, they didn’t need to look like bimbos, like Barbie dolls.” She sought an implant because it was difficult to look at the scarring left behind after her mastectomy.
Mesnil had scans done after she saw the Afssaps alert on the brand. While nothing showed up, she said she decided to replace the implant after hearing the manufacturer cut corners.
When she woke from surgery, her doctor said the implant had ruptured, leaking gel into her body. He’d tried to wash out as much as he could, though he couldn’t be sure he got it all.
“It’s gone somewhere,” Mesnil said over coffee one February morning at her apartment in Malesherbes, south of Paris. “I can’t get it out of my mind.”
To contact the editor responsible for this story: Phil Serafino in Paris at firstname.lastname@example.org