PIP

Meldpunt Klachten Siliconen over PIP

Meldpunt Klachten Siliconen over PIP >>

McGhan met banden met de industrie

The troubled history of PIP's implants man in America >>

(Reuters) - When the French firm at the center of a breast implant scandal sought to expand its U.S. business a decade ago, it turned to Donald McGhan, a pioneer in the implant industry with a history of legal troubles.

McGhan's career traces back to the laboratory at Dow Corning where the first breast implants were made in the early 1960s. By the time he partnered with France's Jean-Claude Mas, founder of Poly Implant Prothese (PIP), in 1999, he had been sued by shareholders who accused him of stealing money, was being investigated by the Securities and Exchange Commission for false accounting and had been replaced from his position as chief executive at one of the world's leading implant makers.

Separately, a Reuters review of securities filings, U.S. product liability lawsuits and interviews with doctors and patients found that saline implants made by PIP and distributed by its U.S. partner MediCor Ltd, founded by McGhan, continued to be used - dodging certain constraints imposed by the FDA - for at least two years after health regulators said they were adulterated and rejected them for sale in the United States.

McGhan has since been jailed for wire fraud for illegally using money from clients in a real estate company in an attempt to build yet another implant business.

The now-defunct PIP was recently found to have sold implants made with industrial-grade silicone to some 300,000 women worldwide, sparking a global health scare. France's government instructed 30,000 French women to have their implants replaced due to a high rupture rate, and the country's health minister has called for Mas to answer for the actions of a "shady business."

In the United States, where the FDA had banned all silicone implants from 1992-2006, PIP sold a line of saline-filled implants starting in 1996. The business accounted for up to 40 percent of its revenue, according to company securities filings. McGhan's MediCor signed on to distribute the products in 1999, but a year later the Food and Drug Administration (FDA) conducted a new review of the devices and decided there wasn't enough data to show they were safe.

The agency then sent an inspector to PIP's plant in France, who found multiple violations of accepted manufacturing practices and determined the products to be "adulterated," Reuters has reported.

Despite that, MediCor continued to book sales of the implants until 2002, according to a MediCor prospectus for a sale of its stock. Reuters interviews with three surgeons and two patients found cases in which women received implants after the 2000 rejection.

Several doctors told Reuters that while PIP had informed them about the FDA rejection, it was their understanding that they could use devices they had in stock to replace implants that ruptured or deflated.

"If you had three in the closet, you could use them. That sort of thing," said Patrick Hudson, a New Mexico plastic surgeon. Hudson said he used PIP implants to replace deflated devices for one of his patients after the FDA rejection. "I don't think even the replacement lasted very long."

Hudson said that nearly all of the 15 or 20 PIP devices that he used in patients eventually failed, which he attributed to the implant's thin membrane.

The FDA confirmed that PIP received a "compassionate use" exception to allow doctors to implant the devices in women whose PIP implants had ruptured or deflated, but only for up to 300 women.

"For women who were suffering from a ruptured implant of this type, it was felt that there were not other implants on the market that would give a satisfactory cosmetic appearance," said Dr. William Maisel, the deputy director and chief scientist of the FDA's devices division, in an interview. For example, if a woman needed to replace only one of two PIP implants, and wanted her body to look symmetrical.

Only women who had previously gotten PIP implants could get a new one under this program, and the FDA asked PIP to remove all other implants from the market in 2000, when the company withdrew its application.

However, it turns out the company did not fully comply with the FDA's requirement.

The FDA said it found out there were still PIP saline implants in the United States in 2002. The agency does not have the exact figures of how many implants were still not collected. But they asked the company to send out letters in 2002 and 2003 to more than 1,000 surgeons, asking them to send back all unused implants to PIP.

Only about 10 to 20 percent responded to the first letter, but more than half responded that they received the second letter, Maisel said.

"It's very unusual (that a company not withdraw its products)," Maisel said. "Our expectation certainly was that the company would remove their product from the market."

The FDA said it is now generally confident PIP's implants are off the U.S. market, as it received reports about 1,810 problems with PIP's saline implants through the end of 2000, and only 48 reports between 2001 and 2009.

FROM LAB TO JAIL CELL

McGhan, who is serving a 10-year sentence in Texas federal prison, turned down a request for an interview on his ties to PIP, delivered through a prison official. Lawyers who have represented him declined to comment.

Mas's lawyer Yves Haddad said his client declined to comment on any ties to McGhan. Mas, who is recuperating from a December surgery in the Var region in southern France, is the subject of an Interpol arrest warrant for a drunk driving incident in Costa Rica. French authorities are considering whether to press charges against any PIP executives.

People who have encountered McGhan describe him as a persuasive salesman who succeeded in spreading his vision for the implant industry among doctors and investors.

"McGhan is the actual architect of the breast implant industry as we know it today," said Pierre Blais, a former advisor to Canada's health regulator. Blais now runs a program that gathers data on implant removals, and offers the information up to government agencies, health insurers and litigators. "He is the true father of all this, with all its sins and glory."

* McGhan got his start in the Dow Corning lab that created the first implants from silicone in 1963 in Hemlock, Michigan, according to Blais. By the mid 1970s, he and several Dow colleagues launched a new implants company, McGhan Medical Corp.

* McGhan sold McGhan Medical to manufacturing giant 3M Corp, bought it back in 1984 and merged it two years later with Inamed Corp, which grew to be one of the largest breast implant makers worldwide along with Johnson & Johnson's Mentor unit. Inamed is now part of Allergan.

* In 1998, McGhan was replaced as Inamed's chairman and chief executive, according to Inamed's securities filings.

* A year later, looking to build yet another implants business, McGhan founded MediCor and signed a deal to become PIP's distributor in the United States.

While McGhan created, sold, bought and merged implants businesses, the industry was rocked by a series of health scares through the 1980s and early 1990s. The devices were found to rupture and leak, and women brought thousands of product liability lawsuits against manufacturers including Dow Corning and 3M. The FDA banned silicone implants for most women from 1992 to 2006 pending additional safety data.

Most of the lawsuits were resolved in a $4 billion class action settlement in 1994. 3M ended up contributing $325 million. Dow Corning ended up bankrupt. Inamed, which estimated it held 40 percent of the global $275 million breast implant market in the mid 1990s, contributed about $32 million shortly after it replaced McGhan.

Among Inamed's many problems under McGhan's tenure was a cash shortage so dire it risked breaking the law by not paying payroll tax on time, according to securities disclosures by its auditors Coopers & Lybrand, who resigned. That prompted regulators to investigate, and Inamed said at the time it was fully cooperating.

To prop up Inamed, McGhan began diverting money from Medical Device Alliance Inc, a liposuction company that he had founded in 1995, according to a lawsuit filed in Nevada state court by company shareholders in 1999. McGhan and his partners raised $14 million from investors to finance research and testing by Medical Device Alliance, the lawsuit said.

"He would run around in a private jet that MDA financed, naturally, and try to impress people with his wealth and try to get doctors and others to put in a lot of money," said Kathryn Tschopik, an attorney who represented MDA shareholders whose money was allegedly diverted by McGhan.

As soon as investors wired money to MDA, McGhan diverted it to Inamed, she alleged. McGhan had argued the money was loaned by MDA to Inamed and was a permitted use of MDA's funds, according to securities disclosures by Inamed.

A receiver was appointed to replace McGhan at MDA, according to Nevada state court records. MDA's shareholders were eventually repaid by McGhan and other defendants, who were able to fund the settlement in part thanks to a sharp rise in Inamed's stock price, Tschopik said.

McGhan also paid a $50,000 fine in 2000 to the Securities and Exchange Commission to settle claims he filed false financial reports for Inamed in 1996 and 1997. He neither admitted nor denied the SEC's claims.

MCGHAN AND MAS "FIT TOGETHER"

As Mas was looking to turn the implants into a global export, McGhan offered Mas his skill as a respected technician and salesman, but also business acumen and a familiarity with doctors in the United States, Blais said.

"The two fit together. Mas made something McGhan could use. McGhan took the initiative to import Mas implants," Blais said.

Even though the FDA rejected PIP's implants in 2000, PIP and McGhan's MediCor aimed to eventually win approval, according to MediCor securities filings. In anticipation of returning to the United States, PIP merged with a shell corporation called Heritage Worldwide Inc in 2003, giving it a U.S.-listed stock.

MediCor soon became its second-largest shareholder, behind an entity owned by Jean-Claude Mas, with a stake of about 7 percent, according to a securities disclosure from Heritage.

McGhan also provided support in other ways. MediCor paid $1.66 million in claims owed by PIP to U.S. women with deflated implants, according to securities disclosures. In 2004, MediCor also forgave some of the $3.4 million PIP owed to it in return for transferring to MediCor PIP's application for FDA approval of its saline implants. At the time, PIP's total revenues for 2003 were $8.4 million and the company booked a net loss of $1.8 million, according to securities disclosures.

Despite the FDA's decision in May 2000 to withhold approval, surgeons continued to use PIP's saline implants in at least a dozen women in California, Michigan, Nevada, New Mexico, Texas and Utah for more than a year afterward, according to lawsuits brought by patients who suffered deflated implants. Only half of them received the implants as replacements.

Doctors were beginning to notice high rupture rates for the products. Grant Stevens of Marina Del Rey, California began to track data on 500 PIP devices implanted between 1996 and 2000 and compare them with 500 implants from Mentor from the same period.

Stevens found the PIP products deflated at a rate that was 3.5 times higher than the Mentor implants. The study was published in the journal Plastic and Reconstructive Surgery in 2006.

Blais, who tracks implants that are removed, also estimated the failure rate after five years at 70 percent, which he attributed to the implants' thin walls, one of the features that made it popular. "The simple act of walking is very abrasive and the shells (of the PIP implants) are not capable of withstanding this vigor and will fail very quickly," he said.

Laine Wich, a Texas dental hygienist and mother of two, had PIP's saline product implanted more than six months after the FDA rejection. While doctors said they operated under the assumption they could use PIP implants as replacements, Wich said they were her first implants from the company. In 2006, they deflated.

"I chose them because they felt more natural," Wich said. She said she followed the advice of her plastic surgeon, Neil Saretsky of Dallas, about the product choices. "I just trusted what he said."

By the time Wich had completed additional surgery to fix the problem, she had spent $10,000 out of pocket. PIP and MediCor offered warranties for up to 10 years, but Wich said it was never honored.

Messages left with the office of Saretsky, who was also listed as a MediCor shareholder in the company's securities disclosures, were not returned.

Nancy Ewert of Bakersfield, California, received PIP replacement implants after the FDA withdrew its approval. She said her doctor told her the PIP products were the only choice, unless she wanted to pay for another brand. "I didn't know they were pulled off the market."

LAST GAMBIT

By the time it became clear that PIP's implants would not drive business for MediCor, McGhan was scrambling for cash to buy yet another breast implant maker.

In May 2004, MediCor signed an agreement to buy Eurosilicone SA, a breast implant maker, for $40 million, according to McGhan's guilty plea for wire fraud. But McGhan was turned down for financing after meeting with various potential lenders, according to his plea agreement. He had until June 30, 2004 to find the cash.

Within weeks, he agreed to buy yet another company called Southwest Exchange Inc, which acted as an intermediary for real estate transactions and was sitting on $100 million of client escrow accounts, more than enough to buy Eurosilicone.

McGhan bought Southwest Exchange on June 28 for $3 million and within two days began sweeping out client money to buy the French implant maker, according to a lawsuit brought by Southwest Exchange clients in Nevada in 2007.

"They had to buy a company, steal the money, launder the money and get it out of the U.S." in a matter of days, said Robert Brace, an attorney who sued McGhan over McGhan's management of Southwest Exchange. "It was an amazing feat, really."

For two years, while the real estate bubble continued to inflate, Southwest Exchange's escrow accounts overflowed with readily available cash to prop up MediCor and, according to the lawsuit, fund a lavish lifestyle. The lawsuit by Southwest Exchange's clients alleges that McGhan diverted their money to buy a 19-seat jet, $1,000 dinners and private schooling for children of the McGhan family. Brace said McGhan even bought a golf course.

When the U.S. real estate market began to founder in the middle of 2006, the net client inflows into Southwest Exchange became severe outflows. McGhan was unable to meet the client cash demands and within a year the Southwest Exchange had collapsed, according to his guilty plea.

By the end of 2007, MediCor was also bankrupt, and McGhan would eventually plead guilty to wire fraud in 2009, according to his guilty plea and bankruptcy court filings. PIP said MediCor's bankruptcy left it with an unpaid debt of $28 million, which represented the sales MediCor had promised but failed to deliver in the U.S. market. The claim was never paid. In 2009, PIP also filed for bankruptcy.

(Additional reporting by Anna Yukhananov in Washington; Editing by Michele Gershberg and Claudia Parsons)

Dochteronderneming PIP Heritage

Artikel (link is helaas verdwenen, wel een ander document gevonden met een gedeelte van de info >> )

Heritage Worldwide, Inc. Subsidiary PIP Receives European Regulatory Approval For World's First Titanium-Coated Breast Implants

NEW YORK, Sept. 9 /PRNewswire-FirstCall/

Introducing another world-first in breast implant technologies, Poly Implants

Protheses (PIP), a subsidiary of Heritage Worldwide, Inc. (OTC Bulletin Board:

HWWI), today announced that it has received CE Mark approval from the

European Union for its titanium-coated breast implants.

The Company has begun sales of the implants in France and is soon to expand sales into the rest of Europe. PIP's titanium-coated breast implants significantly reduce the body's rejection of foreign material and reduce leaks and microholes. These two conditions account for 69% of complications that lead to breast implant removal. Titanium, which is considered one of the most biocompatible materials, fully coats the implant and is the only part of the implant that comes in direct contact with the human body. Through an agreement with GFE Medizintechnik, a German company that is the world leader in titanium-coated medical devices, PIP has the exclusive license for titanium-coated breast implant technology for the next six years. "In our continuing quest to create the world's most advanced and safety-focused breast implants, we are very proud of having launched our titanium-coated implants in Europe. While we expect that this product will create a significant competitive advantage for us in the EU, we are also forging forward with preparing for approval processes in the U.S. and in other major markets," stated PIP President and CEO Mr. Jean Claude Mas.

About Heritage Worldwide: Heritage Worldwide, Inc. recently acquired France-based Poly Implants Protheses, S.A. (PIP), the third largest breast implant manufacturer in the world. PIP develops, manufactures, and markets a diverse line of such implants in a variety of shapes, sizes, and textures. PIP's products also include body support products and other implants and are sold in 40 countries across the globe. The Company plans to apply for FDA approval of its implants by early 2004. PIP has consistently been a leading innovator in the breast implant industry. It was the first company to introduce hydrogel breast prosthesis in 1992. A year later, PIP launched the first saline pre-filled breast implant with technology that provides unique advantages over inflatable implants. Last year PIP produced the first asymmetric prosthesis to alleviate the risk of rotation that is apparent in anatomical prostheses. Further information about the Company is available in a research report which can accessed at: http://www.stocksontheweb.com/hwwi.htm. Safe Harbor Statement: Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the Company's beliefs and the assumptions it made using information currently available to it. Because these statements reflect the Company's current views concerning future events, these statements involve risks, uncertainties and assumptions. The actual results could differ materially from the results discussed in the forward-looking statements. In any event, undue reliance should not be placed on any forward-looking statements, which apply only as of the date of this press release.

SOURCE Heritage Worldwide, Inc.

Geschiedenis van PIP man in Amerika

The troubled history of PIP's implants man in America >>

Tuesday, Jan 10, 2012, 19:46 IST | Place: Wilmington | Agency: Reuters

McGhan's career traces back to the laboratory at Dow Corning where the first breast implants were made in the early 1960s.

When the French firm at the center of a breast implant scandal sought to expand its US business a decade ago, it turned to Donald McGhan, a pioneer in the implant industry with a history of legal troubles.

McGhan's career traces back to the laboratory at Dow Corning where the first breast implants were made in the early 1960s. By the time he partnered with France's Jean-Claude Mas, founder of Poly Implant Prothese (PIP), in 1999, he had been sued by shareholders who accused him of stealing money, was being investigated by the Securities and Exchange Commission for false accounting and had been replaced from his position as chief executive at one of the world's leading implant makers.

Separately, a Reuters review of securities filings, U.S. product liability lawsuits and interviews with doctors and patients found that saline implants made by PIP and distributed by its U.S. partner MediCor Ltd, founded by McGhan, continued to be used - dodging certain constraints imposed by the FDA - for at least two years after health regulators said they were adulterated and rejected them for sale in the United States.

McGhan has since been jailed for wire fraud for illegally using money from clients in a real estate company in an attempt to build yet another implant business.

The now-defunct PIP was recently found to have sold implants made with industrial-grade silicone to some 300,000 women worldwide, sparking a global health scare. France's government instructed 30,000 French women to have their implants replaced due to a high rupture rate, and the country's health minister has called for Mas to answer for the actions of a "shady business.

In the United States, where the FDA had banned all silicone implants from 1992-2006, PIP sold a line of saline-filled implants starting in 1996. The business accounted for up to 40 percent of its revenue, according to company securities filings. McGhan's MediCor signed on to distribute the products in 1999, but a year later the Food and Drug Administration (FDA) conducted a new review of the devices and decided there wasn't enough data to show they were safe.

The agency then sent an inspector to PIP's plant in France, who found multiple violations of accepted manufacturing practices and determined the products to be "adulterated," Reuters has reported.

Despite that, MediCor continued to book sales of the implants until 2002, according to a MediCor prospectus for a sale of its stock. Reuters interviews with three surgeons and two patients found cases in which women received implants after the 2000 rejection.

Several doctors told Reuters that while PIP had informed them about the FDA rejection, it was their understanding that they could use devices they had in stock to replace implants that ruptured or deflated.

"If you had three in the closet, you could use them. That sort of thing," said Patrick Hudson, a New Mexico plastic surgeon. Hudson said he used PIP implants to replace deflated devices for one of his patients after the FDA rejection. "I don't think even the replacement lasted very long."

Hudson said that nearly all of the 15 or 20 PIP devices that he used in patients eventually failed, which he attributed to the implant's thin membrane.

The FDA confirmed that PIP received a "compassionate use" exception to allow doctors to implant the devices in women whose PIP implants had ruptured or deflated, but only for up to 300 women.

"For women who were suffering from a ruptured implant of this type, it was felt that there were not other implants on the market that would give a satisfactory cosmetic appearance," said Dr. William Maisel, the deputy director and chief scientist of the FDA's devices division, in an interview. For example, if a woman needed to replace only one of two PIP implants, and wanted her body to look symmetrical.

Only women who had previously gotten PIP implants could get a new one under this program, and the FDA asked PIP to remove all other implants from the market in 2000, when the company withdrew its application.

However, it turns out the company did not fully comply with the FDA's requirement.

The FDA said it found out there were still PIP saline implants in the United States in 2002. The agency does not have the exact figures of how many implants were still not collected. But they asked the company to send out letters in 2002 and 2003 to more than 1,000 surgeons, asking them to send back all unused implants to PIP.

Only about 10 to 20 percent responded to the first letter, but more than half responded that they received the second letter, Maisel said.

"It's very unusual (that a company not withdraw its products)," Maisel said. "Our expectation certainly was that the company would remove their product from the market."

The FDA said it is now generally confident PIP's implants are off the U.S. market, as it received reports about 1,810 problems with PIP's saline implants through the end of 2000, and only 48 reports between 2001 and 2009.

From lab to jail cell

McGhan, who is serving a 10-year sentence in Texas federal prison, turned down a request for an interview on his ties to PIP, delivered through a prison official. Lawyers who have represented him declined to comment.

Mas's lawyer Yves Haddad said his client declined to comment on any ties to McGhan. Mas, who is recuperating from a December surgery in the Var region in southern France, is the subject of an Interpol arrest warrant for a drunk driving incident in Costa Rica. French authorities are considering whether to press charges against any PIP executives.

People who have encountered McGhan describe him as a persuasive salesman who succeeded in spreading his vision for the implant industry among doctors and investors.

"McGhan is the actual architect of the breast implant industry as we know it today," said Pierre Blais, a former advisor to Canada's health regulator. Blais now runs a program that gathers data on implant removals, and offers the information up to government agencies, health insurers and litigators. "He is the true father of all this, with all its sins and glory."

* McGhan got his start in the Dow Corning lab that created the first implants from silicone in 1963 in Hemlock, Michigan, according to Blais. By the mid 1970s, he and several Dow colleagues launched a new implants company, McGhan Medical Corp.

* McGhan sold McGhan Medical to manufacturing giant 3M Corp, bought it back in 1984 and merged it two years later with Inamed Corp, which grew to be one of the largest breast implant makers worldwide along with Johnson & Johnson's Mentor unit. Inamed is now part of Allergan.

* In 1998, McGhan was replaced as Inamed's chairman and chief executive, according to Inamed's securities filings.

* A year later, looking to build yet another implants business, McGhan founded MediCor and signed a deal to become PIP's distributor in the United States.

While McGhan created, sold, bought and merged implants businesses, the industry was rocked by a series of health scares through the 1980s and early 1990s. The devices were found to rupture and leak, and women brought thousands of product liability lawsuits against manufacturers including Dow Corning and 3M. The FDA banned silicone implants for most women from 1992 to 2006 pending additional safety data.

Most of the lawsuits were resolved in a $4 billion class action settlement in 1994. 3M ended up contributing $325 million. Dow Corning ended up bankrupt. Inamed, which estimated it held 40 percent of the global $275 million breast implant market in the mid 1990s, contributed about $32 million shortly after it replaced McGhan.

Among Inamed's many problems under McGhan's tenure was a cash shortage so dire it risked breaking the law by not paying payroll tax on time, according to securities disclosures by its auditors Coopers & Lybrand, who resigned. That prompted regulators to investigate, and Inamed said at the time it was fully cooperating.

To prop up Inamed, McGhan began diverting money from Medical Device Alliance Inc, a liposuction company that he had founded in 1995, according to a lawsuit filed in Nevada state court by company shareholders in 1999. McGhan and his partners raised $14 million from investors to finance research and testing by Medical Device Alliance, the lawsuit said.

"He would run around in a private jet that MDA financed, naturally, and try to impress people with his wealth and try to get doctors and others to put in a lot of money," said Kathryn Tschopik, an attorney who represented MDA shareholders whose money was allegedly diverted by McGhan.

As soon as investors wired money to MDA, McGhan diverted it to Inamed, she alleged. McGhan had argued the money was loaned by MDA to Inamed and was a permitted use of MDA's funds, according to securities disclosures by Inamed.

A receiver was appointed to replace McGhan at MDA, according to Nevada state court records. MDA's shareholders were eventually repaid by McGhan and other defendants, who were able to fund the settlement in part thanks to a sharp rise in Inamed's stock price, Tschopik said.

McGhan also paid a $50,000 fine in 2000 to the Securities and Exchange Commission to settle claims he filed false financial reports for Inamed in 1996 and 1997. He neither admitted nor denied the SEC's claims.

Mcghan and mas "fit together"

As Mas was looking to turn the his implants into a global export, McGhan offered Mas his skill as a respected technician and salesman, but also business acumen and a familiarity with doctors in the United States, Blais said.

"The two fit together. Mas made something McGhan could use. McGhan took the initiative to import Mas implants," Blais said.

Even though the FDA rejected PIP's implants in 2000, PIP and McGhan's MediCor aimed to eventually win approval, according to MediCor securities filings. In anticipation of returning to the United States, PIP merged with a shell corporation called Heritage Worldwide Inc in 2003, giving it a U.S.-listed stock.

MediCor soon became its second-largest shareholder, behind an entity owned by Jean-Claude Mas, with a stake of about 7 percent, according to a securities disclosure from Heritage.

McGhan also provided support in other ways. MediCor paid $1.66 million in claims owed by PIP to U.S. women with deflated implants, according to securities disclosures. In 2004, MediCor also forgave some of the $3.4 million PIP owed to it in return for transferring to MediCor PIP's application for FDA approval of its saline implants. At the time, PIP's total revenues for 2003 were $8.4 million and the company booked a net loss of $1.8 million, according to securities disclosures.

Despite the FDA's decision in May 2000 to withhold approval, surgeons continued to use PIP's saline implants in at least a dozen women in California, Michigan, Nevada, New Mexico, Texas and Utah for more than a year afterward, according to lawsuits brought by patients who suffered deflated implants. Only half of them received the implants as replacements.

Doctors were beginning to notice high rupture rates for the products. Grant Stevens of Marina Del Rey, California began to track data on 500 PIP devices implanted between 1996 and 2000 and compare them with 500 implants from Mentor from the same period.

Stevens found the PIP products deflated at a rate that was 3.5 times higher than the Mentor implants. The study was published in the journal Plastic and Reconstructive Surgery in 2006.

Blais, who tracks implants that are removed, also estimated the failure rate after five years at 70 percent, which he attributed to the implants' thin walls, one of the features that made it popular. "The simple act of walking is very abrasive and the shells (of the PIP implants) are not capable of withstanding this vigor and will fail very quickly," he said.

Laine Wich, a Texas dental hygienist and mother of two, had PIP's saline product implanted more than six months after the FDA rejection. While doctors said they operated under the assumption they could use PIP implants as replacements, Wich said they were her first implants from the company. In 2006, they deflated.

"I chose them because they felt more natural," Wich said. She said she followed the advice of her plastic surgeon, Neil Saretsky of Dallas, about the product choices. "I just trusted what he said."

By the time Wich had completed additional surgery to fix the problem, she had spent $10,000 out of pocket. PIP and MediCor offered warranties for up to 10 years, but Wich said it was never honored.

Messages left with the office of Saretsky, who was also listed as a MediCor shareholder in the company's securities disclosures, were not returned.

Nancy Ewert of Bakersfield, California, received PIP replacement implants after the FDA withdrew its approval. She said her doctor told her the PIP products were the only choice, unless she wanted to pay for another brand. "I didn't know they were pulled off the market."

Last gambit

By the time it became clear that PIP's implants would not drive business for MediCor, McGhan was scrambling for cash to buy yet another breast implant maker.

In May 2004, MediCor signed an agreement to buy Eurosilicone SA, a breast implant maker, for $40 million, according to McGhan's guilty plea for wire fraud. But McGhan was turned down for financing after meeting with various potential lenders, according to his plea agreement. He had until June 30, 2004 to find the cash.

Within weeks, he agreed to buy yet another company called Southwest Exchange Inc, which acted as an intermediary for real estate transactions and was sitting on $100 million of client escrow accounts, more than enough to buy Eurosilicone.

McGhan bought Southwest Exchange on June 28 for $3 million and within two days began sweeping out client money to buy the French implant maker, according to a lawsuit brought by Southwest Exchange clients in Nevada in 2007.

"They had to buy a company, steal the money, launder the money and get it out of the U.S." in a matter of days, said Robert Brace, an attorney who sued McGhan over McGhan's management of Southwest Exchange. "It was an amazing feat, really."

For two years, while the real estate bubble continued to inflate, Southwest Exchange's escrow accounts overflowed with readily available cash to prop up MediCor and, according to the lawsuit, fund a lavish lifestyle. The lawsuit by Southwest Exchange's clients alleges that McGhan diverted their money to buy a 19-seat jet, $1,000 dinners and private schooling for children of the McGhan family. Brace said McGhan even bought a golf course.

When the U.S. real estate market began to founder in the middle of 2006, the net client inflows into Southwest Exchange became severe outflows. McGhan was unable to meet the client cash demands and within a year the Southwest Exchange had collapsed, according to his guilty plea.

By the end of 2007, MediCor was also bankrupt, and McGhan would eventually plead guilty to wire fraud in 2009, according to his guilty plea and bankruptcy court filings. PIP said MediCor's bankruptcy left it with an unpaid debt of $28 million, which represented the sales MediCor had promised but failed to deliver in the U.S. market. The claim was never paid. In 2009, PIP also filed for bankruptcy.

Drie bedrijfsleiders PIP overleden

Prothèses PIP: le cercle des associés disparus Artikel +Vertaling

Affaires. Trois administrateurs des sociétés de Jean-Claude Mas, qui avaient élaboré des montages financiers complexes, sont décédés.

Par OLIVIER BERTRAND Envoyé spécial à Toulon

Il ne faisait pas bon être associé de Jean-Claude Mas, fondateur de PIP, fabricant de prothèses mammaires emplies de gel toxique. Cela portait la poisse. Depuis 2007, trois administrateurs de sociétés qui contrôlaient PIP pour son compte depuis le Luxembourg et les Etats-Unis sont morts, emportant les secrets d’un montage complexe. Comme on en rencontre d’ordinaire dans les dossiers d’évasion fiscale ou de blanchiment.

Iles Vierges. Dès le début des années 90, plusieurs sociétés ont été montées au Luxembourg et aux îles Vierges, charmant paradis fiscal. Parmi elles, Milo Finance, créée en 1998 pour prendre le contrôle de PIP - et monter parallèlement des sociétés civiles immobilières (SCI). Notamment la SCI Prince Michel, créée avec des apports en espèces pour acheter, à Six-Fours-les-Plages (Var), une maison dans laquelle vit aujourd’hui la famille Mas. Un homme portait les parts de Jean-Claude Mas dans toutes ces sociétés : Alain Sereyjol-Garros, juriste français reconverti conseiller fiscal au Grand-Duché. Mais, au milieu des années 2000, Jean-Claude Mas a des soucis avec lui. «Monsieur Sereyjol, qui était l’actionnaire principal, m’a fait chanter», indiquera-t-il aux gendarmes le 18 novembre 2010.

Cela ne dure pas : le 27 janvier 2007, après une première tentative sept mois plus tôt, Alain Sereyjol-Garros se défenestre de son appartement du centre de Luxembourg. Pas d’effraction, pas d’enquête de police. Selon un beau-frère, le suicide a été très inattendu, mais Alain Sereyjol-Garros avait d’autres soucis que PIP. Une ancienne responsable de l’entreprise a raconté la suite aux gendarmes : «A la mort de [Sereyjol], son compagnon - je ne me souviens plus de son nom - a hérité de la société. Lui aussi est mort. A ce moment-là, s’est posée la question de savoir comment M. Mas pouvait prouver qu’il détenait la société Milo.»

Le compagnon en question s’appelait Fabio Pezzera. Il a été retrouvé par sa femme de ménage le 20 mai 2007, dans le même appartement d’où Sereyjol s’était jeté. Il aurait fait une overdose à 39 ans. En guise d’épitaphe, les statuts des entreprises montées pour le compte de Mas indiquent que les deux hommes ont été «révoqués» quelques semaines après leur mort. Le procureur du Luxembourg a depuis demandé la liquidation des principales sociétés. Elles n’avaient pas de siège social au Luxembourg, pas de comptes déposés depuis 2002.

Un fonds de pension américain, Gem, associé de Milo Finance dans un holding monté en 2003 aux Etats-Unis pour introduire PIP en Bourse, a alors saisi la justice luxembourgeoise. Il réclame une créance de 3 millions de dollars (2,3 millions d’euros). Le représentant en France de ce fonds s’appelait Fabrice Viguier, un banquier d’affaires varois longtemps proche de Mas. Après la fermeture de PIP, il a tenté de reprendre pour le compte de Gem une partie des actifs de l’entreprise, contre l’avis de Mas, qui développait un projet similaire avec ses enfants. Mais Fabrice Viguier s’est tué à moto, en compagnie d’un ancien importateur de PIP, en août 2011.

«Banqueroute». La famille Mas a finalement abandonné, cet hiver, l’idée de reprendre l’activité, devant l’ampleur du scandale. Les procédures pénales et civiles se multiplient, mais Jean-Claude Mas a soigneusement organisé son insolvabilité. En juillet 2010, il a déposé au registre du commerce de Luxembourg un document, daté de 1999, dans lequel Alain Sereyjol-Garros cède à Jean-Claude Mas et sa compagne les parts dans la SCI Prince Michel, propriétaire de la luxueuse maison de Six-Fours. Puis, en septembre 2010, Jean-Claude Mas a cédé ses parts à sa compagne et à leur fils, pour se retrouver sans le sou.

Vendredi, une avocate, Christine Ravaz, a demandé au parquet de Toulon d’enquêter sur des soupçons de «banqueroute frauduleuse, abus de biens sociaux, organisation frauduleuse d’insolvabilité et blanchiment aggravé» visant l’ancien patron (qui n’a pas souhaité répondre à nos questions) et sa famille.

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Affaire PIP : les montages financiers acrobatiques de M. Mas Artikel +Vertaling

Jean-Claude Mas était un bon vendeur. Mais le patron de la société PIP n'a jamais eu le goût de la gestion d'entreprise, de la tenue des comptes, du détail financier,déclarait récemment au Monde son avocat, Me Yves Haddad, qui le fréquente depuis cinq ans. Est-ce pour cela que l'argent de sa société s'avère à ce point difficile à retrouver pour la justice ?

En 2007, au sommet de sa gloire, la compagnie réalisait un chiffre d'affaire de plus de 13 millions d'euros, notamment grâce aux talents de VRP de M. Mas en Amérique latine, où il écoulait l'essentiel de ses implants mammaires défectueux. C'était avant que la crise économique n'épuise son carnet de commande et ses clients douteux ; avant que la multiplication des accidents et des plaintes ne jette le doute sur les implants PIP.

Vendredi 20 janvier, à Toulon, le liquidateur de l'entreprise varoise mise en faillite en mars 2010 était assigné en référé. Il ne s'est pas présenté à l'audience, "faute de fonds en compte". Une plainte a été déposée le même jour par une victime contre la famille de Mas, contre PIP et contre X. Elle vise notamment des faits de banqueroute frauduleuse, d'abus de bien sociaux, d'organisation d'insolvabilité et de blanchiment aggravé. "Nous voulons savoir où sont passés les actifs de PIP", a résumé Me Christine Ravaz, l'avocate de la victime. La tâche risque d'être difficile.

PARADIS FISCAUX ET ÉCHAPPÉE AMÉRICAINE

En 1998, la compagnie PIP, fondée dans le Var sept ans plus tôt, passe sous le contrôle de deux sociétés-écrans basées au Luxembourg, Milo Finance et Penny Holding. Les deux compagnies sont administrées par un juriste français installé dans le duché, Alain Sereyjol-Garros, suicidé en 2007.

Ce sont ces sociétés-écrans qui coifferont PIP lorsque la compagnie s'en ira quêter de l'argent frais auprès de fonds d'investissements américains en 2003, sous un prête-nom local, pour continuer à se développer. Selon les déclarations de M. Mas aux gendarmes, les banques européennes "abandonnaient" alors sa compagnie, en "supprimant des lignes d'escompte".

Jean-Claude Mas s'allie donc à un aventurier de la chirurgie esthétique, Donald McGhan, ancien employé du laboratoire de Dow Corning, la société qui fabriqua les premiers implants mammaires américains, au début des années 1960. McGhan, qui a dirigé plus tard l'une des principales société d'implants au monde et connu de nombreux démélés avec la justice, purge aujourd'hui une peine de dix ans de prison au Texas, pour avoir utilisé à son compte les fonds de ses clients dans une compagnie immobilière.

Les deux hommes se partagent les parts de la compagnie Heritage Worldwide, qui rachète 94 % de PIP en février 2003 à Milo Finance, selon le rapport de l'administrateur judiciaire de la compagnie au Tribunal de commerce de Toulon, qui a prononcé la liquidation de PIP le 30 mars 2010. La société est basée dans l'Etat du Delaware, souvent considéré comme un paradis fiscal. L'introduction d'Heritage en bourse, sur le segment OTC du Nasdaq, lui a permis de leverplusieurs millions de dollars.

MORT DES ADMINISTRATEURS

Parmi les administrateurs de Heritage, on retrouvait, en 2003, M. Sereyjol-Garros, qui sera écarté peu après de la gouvernance des compagnies par M. Mas. Aux gendarmes, ce dernier a décrit son associé luxembourgeois comme le "principal actionnaire" de PIP. Il l'accuse de l'avoir fait "chanter" en 2005 "sur des déclarations fausses concernant l'entrée en Bourse" de la compagnie aux Etats-Unis.

D'après une source judiciaire au Luxembourg, M. Sereyjol-Garros s'est jeté par la fenêtre de son appartement, fin janvier 2007, à 66 ans. Selon Libération, il avait fait une première tentative de suicide à l'été 2006. Son compagnon, Fabio Pezzera, est mort d'une overdose quatre mois plus tard, dans le même appartement, à 39 ans.

La mort de ces deux hommes, non déclarée au registre du commerce luxembourgeois bien que la loi l'impose, a entraîné la liquidation des sociétés qu'ils administraient - sans siège social au Luxembourg ni comptes déposés depuis 2002, selon Libération. La procédure est toujours en cours.

En août 2011, un troisième homme ayant travaillé aux montages financiers de PIP est mort, dans un accident de moto, dans le Var : le banquier d'affaire Fabrice Viguier, qui avait organisé le rachat de PIP par son prête-nom américain Heritage, via le fonds de pension californien Gem. Il réclamait une créance de 2,3 millions d'euros à PIP devant la justice luxembourgeoise. Après la fermeture de PIP, Gem avait été choisi comme repreneur de l'entreprise, alors que M. Mas développait un projet concurrent avec sa famille.

Medicor met handelsnaam PIP

Legal proceedings

In October 1999, June 2000 and July 2003, separate but related complaints were filed by Saul Kwartin, Steven M. Kwartin, and Robert and Nina Kwartin respectively, and various other unnamed plaintiffs, against III Acquisition Corporation, a Delaware corporation (which operates under the tradename PIP.America), a subsidiary of MediCor, as co-defendant with PIP/USA, Inc. and Poly Implants Prostheses, S.A., each unaffiliated with MediCor, and Jean Claude Mas and our chairman, personally, in the Circuit Court of Miami-Dade County, Florida. In the first two cases, plaintiffs purport to be shareholders of PIP/USA, Inc. suing derivatively on its behalf, and seeking to rescind various transactions between PIP.America and PIP/USA, Inc. and seek to impose liability against PIP.America and its co-defendants for unspecified monetary damages arising out of alleged tortuous and other purported wrongful acts concerning alleged relationships between plaintiffs, PIP/USA, Inc. and Poly Implants Prostheses. In the third case, filed in 2003, MediCor is named but has not yet been served, but does anticipate being a defendant. >>

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Breast implant competition heats up

As they prepare to make the jump to silicone, Mentor and Inamed have the American breast implant market all to themselves, but they could soon face competition from an industry legend unnoticed by many investors.

MediCor Ltd., founded in 1999 by its chairman, Donald McGhan, is getting ready to muscle its way into the United States with a new saline implant.

While Mentor (down $2.20 to $50.36, Research) and Inamed (Research) fight for a majority stake, MediCor has been buying companies overseas. Based in Las Vegas and traded over the counter, MediCor is not just some young upstart or foreign interloper. McGhan also founded Inamed and was its CEO, created the product line now used by Mentor, and helped invent the first breast implant with Dow Corning, back in 1963.

"[McGhan] is the grandfather of breast implants, if you will," said Amit Hazan, analyst for Suntrust Robinson Humphrey.

McGhan's first implant was made of silicone gel. But the Food and Drug Administration pulled silicone implants off the market in 1991 because of concerns about ruptures and leaks. In the United States, silicone implants are approved only for reconstructive surgery following mastectomies.

However, the $350 million U.S. implant market is poised to change radically because Mentor and Inamed, which both sell silicone implants overseas, are trying to get them approved by the FDA for cosmetic use. Both companies have received approvable letters from the FDA, which usually serves as a precursor to market approval. Both companies are in good standing with investors, having seen their stock value increase more than 50 percent during the last 12 months.

MediCor buys up the competition

MediCor, which totaled about $20 million in sales during the first three quarters of 2005, produces silicone implants for the European and South American markets, where the use of silicone is not restricted. With its recent acquisition of British implant maker Biosil Limited and supplier Nagor Limited, MediCor says it now holds 30 percent of the non-U.S. market share for breast implants. This recent deal follows the 2004 acquisition of the French implant maker Eurosilicone and the 2000 acquisition of Biodermis, maker of scar management materials.

MediCor chief executive officer Theodore Maloney proclaimed the silicone implant as "the product of choice, for the most part" and said "it is our absolute market objective to bring silicone implants into the U.S." However, MediCor could be years behind its competitors in submitting silicone implant applications to the FDA, so it is relying on saline for now.

California-based Inamed and Mentor sell implants that are filled with saline during surgery, after they are placed inside the patient's body. But MediCor has developed an implant that is pre-filled with saline at the factory. MediCor plans to submit a traditional saline implant to the FDA in the fourth quarter of 2005, followed by the next-generation pre-filled implant in 2006.

"We have two feet on the beach in the U.S. market with these two saline products," Maloney said. "[The next generation-saline implant] is physically more similar to a silicone implant than the inflatable saline implant."

Saline versus silicone: who wins?

McGhan believes that saline will continue to be a big seller, even with the likely approval of silicone.

"The whole market isn't going to switch to silicone gel," McGhan said. "We believe very strongly that the saline-filled breast market will be somewhere around 25 to 30 percent of the market after silicone's back on the market."

But analysts aren't so sure.

"I like the strategy they're taking, which is to consolidate the smaller players outside the U.S. to become a stronger player," said Hazan, the analyst for Suntrust Robinson Humphrey. But, despite the venerable presence of McGhan, Hazan said MediCor's saline strategy is "risky at best." Hazan said that 90 percent of the non-U.S. market is silicone.

"It's like they're working very hard on the Beta tape and they don't realize people are watching DVDs," said Hazan, comparing the outmoded video tape with saline implants.

MediCor is bolstered by strong leadership and would put price pressure on its U.S. competitors, said Jayson Bedford, analyst for Adams Harkness. But he said the company's market model depends heavily on the FDA's silicone decisions.

"If the FDA approves silicone, I think that MediCor will be coming into the market to somewhat of a disadvantage, relative to the other companies," said Bedford. "But if the FDA does not approve, I think MediCor is on much stronger footing."

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MediCor Ltd. Subsidiary Obtains $20 Million Loan Facility

LAS VEGAS--(BUSINESS WIRE)--Sept. 13, 2004--MediCor Ltd. (OTCBB:MDCR) today announced that its French subsidiary ES Holdings SAS has signed a loan agreement with BNP Paribas providing for up to $20 million in financing. The loan agreement follows MediCor's recent acquisition of Laboratoires Eurosilicone SA, which is now wholly owned by ES Holdings. The loan agreement reflects the completion of MediCor's contemplated financing relating to the Eurosilicone acquisition.

The term of the loan agr

eement is for seven years and includes an initial funding of approximately $9.0 million, with additional availability of approximately $11.0 million to finance payments in connection with the Laboratoires Eurosilicone acquisition.Thomas Moyes, Chief Financial Officer of MediCor Ltd., said, "We are very pleased with our loan agreement with BNP Paribas, which represents a positive development for MediCor following its Eurosilicone acquisition. This new credit facility provides enhanced financial resources to support MediCor's continued growth and focus on its core aesthetic, plastic and reconstructive surgery markets worldwide. The loan agreement is consistent with MediCor's objectives to closely manage financial resources to operate efficiently and take advantage of business opportunities. We look forward to working with BNP Paribas." MediCor Ltd. Chief Executive Officer Theodore Maloney added, "The financing with BNP Paribas is yet another acknowledgement of the value of the Eurosilicone franchise, one we intend to leverage and integrate with the premier team in the breast implant industry led by Donald K. McGhan. This new capital will enable us to continue to advance the industry through unequaled innovation, marketing and support, hallmarks of the McGhan management strategy. We are delighted to expand Eurosilicone's relationship with BNP Paribas." About MediCor MediCor acquires, develops, manufactures and markets products for medical specialties in aesthetic, plastic and reconstructive surgery and dermatology markets. Its products are sold worldwide to hospitals, surgery centers and physicians through a combination of distributors and direct sales personnel. MediCor's objective is to be a leading supplier of selected international medical devices and technologies. To achieve this strategy, MediCor intends to build upon and expand its business lines, primarily in the aesthetic, plastic and reconstructive surgery and dermatology markets. MediCor intends to accomplish this growth through the expansion of existing product lines and offerings and through the acquisition of companies and other assets, including intellectual property rights and distribution rights. About Eurosilicone, a wholly-owned subsidiary of MediCor Ltd., develops, manufactures and markets a full range of breast implants for the aesthetic, plastic and reconstructive surgery markets, including silicone gel and inflatable saline-filled breast implants, with both round and anatomical shapes, and smooth or unique micro-textured surfaces. Eurosilicone also markets a line of external breast prostheses under the Maxima brand sold by its Europrotex division, available in six different shapes and a wide range of sizes. Eurosilicone also manufactures and markets a range of other silicone implants, including tissue expanders, testicular implants, gluteus implants, calf implants, nasal implants, malar implants and chin implants. Forward Looking Statements in this press release may involve forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including forward-looking statements regarding MediCor's future credit availability and growth plans. Such statements are based upon the current beliefs and expectations of MediCor's management and are subject to significant risks and uncertainties, including external factors such as interest rate fluctuations, research and development and marketing expenditures, changes in customer spending and other factors over many of which management has no control. These forward-looking statements should be evaluated together with additional information about MediCor's business, markets, conditions and other uncertainties, which could affect MediCor's future performance, which are contained in MediCor's Annual Report on Form 10-KSB for the year ended June 30, 2003 and its other filings with the Securities and Exchange Commission and available at the Securities and Exchange commission's Internet site (http://www.sec.gov), which are incorporated into this press release by reference. Actual results may vary materially because of risks and uncertainties. This press release speaks only as of its date, and MediCor disclaims any duty to update the information herein. >>

CONTACT: MediCor Ltd. Marc S. Sperberg, 702-932-4560 x308

Chemical in faulty breast implants used by up to 47,000 women in UK 'causes damage to unborn babies'

  • Faulty PIP implants may pose pregnancy risk, according to experts

  • Health officials say chemicals used to make them are of' high concern'

  • PIP implants already under fire for being more likely to rupture

Women with faulty PIP breast implants are at risk of chemical exposure that causes damage to unborn babies, experts have warned. Their report disputes previous warnings by the NHS that material inside the implants was ‘not toxic or carcinogenic’. The scientists are now calling for an inquiry into the potential side effects of PIPs. Up to 47,000 British women could have received the French implants which were fraudulently filled with an industrial-grade silicone designed for mattresses. Testing has previously revealed that PIP implants were up to six times as likely to rupture as other brands. Writing in the Journal of the Royal Society of Medicine, the group of experts called for women to be given ‘full information’ by British authorities. The consumer protection group Antidote Europe said it disagreed with a report by the British Medicines and Healthcare Products Regulation Authority (MHRA) that suggested the implants did not contain hazardous materials. The body identified dangerous levels of chemicals in the implants, with one known as D4 being deemed of ‘high concern’ by European health officials. 2013 >>

Antidote Europe director and co-author of the report, Andre Menache, said: ‘Considering these known risks and the fact that most women receiving breast implants were of reproductive age, we would expect the MHRA and the Department of Health to fulfil its duty of care and thoroughly investigate these risks as well as provide full information to patients.’ The report says that thorough analysis of the gel within the PIP implants has yet to be carried out and also points towards possible contamination with lead, platinum and zinc during production >>