Fw: Oklahoma City PS busted for smuggling implants from Brazil ~ 6/96

[Guest guest]

> From: " Ilena Rose " <ilena@...>

> Sent: Tuesday, August 07, 2001 11:48 AM

> Subject: Oklahoma City PS busted for smuggling implants from Brazil ~ 6/96

> >

> > http://www.fda.gov/fdac/departs/696_irs.html

> >

> > ------------------------------------------------------------------------

> >

> >

> > Investigators' Reports

> >

> > Doctor Jailed for Violating

> > Breast Implant Restrictions

> > by a Kurtzweil

> >

> > A 55-year-old Oklahoma City doctor who performs breast augmentation is

> > serving six months in federal prison for smuggling into the United

States

> > unapproved silicone gel-filled breast implants from a foreign

> > manufacturer.

> >

> > J. Dan Metcalf, M.D., a family practitioner, is believed to be the first

> > person prosecuted for violating U.S. restrictions on use of unapproved

> > silicone gel-filled breast implants. He illegally imported the implants

> > from Brazil and the Bahama Islands, used them to enlarge the breasts of

> > 200 women, and sold some to other U.S. doctors. The federal

investigation

> > continues, according to Special Agent Kent Wood of FDA's Office of

> > Criminal Investigations.

> >

> > Since April 1992, FDA has allowed silicone gel-filled breast implants

only

> > in women enrolled in clinical studies, and then mainly for

reconstruction

> > after breast cancer surgery and certain other medical conditions. At

this

> > time, women who want implants for augmentation (breast enlargement) must

> > get saline-filled breast implants.

> >

> > FDA issued a three-month moratorium in April 1992, following years of

> > debate on the safety of silicone gel-filled breast implants and whether

or

> > not the medical devices should remain on the market. FDA turned down

> > manufacturers' applications for approval of the implants submitted after

> > the three-month moratorium because FDA found that the information was

not

> > sufficient to prove the safety and effectiveness of the devices. The

> > studies under way are intended to provide more definite information

about

> > implant safety. (See " A Status Report on Breast Implant Safety " in the

> > November 1995 FDA Consumer.)

> >

> > Metcalf was indicted in the U.S. District Court for the Western District

> > of Oklahoma in July 1995. He was sentenced last March. In addition to

the

> > prison sentence, he was fined $5,000, ordered to forfeit assets of about

> > $312,000, and sentenced to one year's probation.

> >

> > FDA, along with U.S. Customs and the Internal Revenue services, began

> > investigating Metcalf in early 1994, after Metcalf's former office

> > manager, who also doubled as Metcalf's surgical assistant, and her

mother

> > reported the doctor's activities to investigator Lloyd Paine at FDA's

> > Oklahoma City resident post. The former office manager, who provided

most

> > of the information, said she had quit her job because Metcalf's wife,

her

> > sister, had been taking over her role in the business. She provided

> > photocopied documentation of Metcalf's activities, including lists of

> > patients' names and records of phone calls and financial transactions

> > between the doctor and his implant sources.

> >

> > Armed with this information--and a search warrant--FDA, Customs and IRS

> > special agents searched Metcalf's office, residence, and bank safe

deposit

> > box on May 24, 1994. At Metcalf's office and residence, they seized 470

> > pairs of silicone gel-filled breast implants, worth about $200,000,

> > medical records of all patients who had received silicone breast

implants

> > since April 1992, and various business records.

> >

> > With this information, the agencies determined that Metcalf had been

> > importing silicone breast implants made by the Brazilian silicone

implant

> > company Silimed, of Rio de Janeiro, since shortly after FDA turned down

> > the implant manufacturers' applications in 1992. According to FDA's

Wood,

> > Metcalf tried to buy direct from the Brazilian company, but the head of

> > the company told him he would not do business in the United States. So,

> > Metcalf arranged to buy the implants through doctors in Brazil and

Nassau,

> > in the Bahamas.

> >

> > Metcalf had the implants delivered through such mail carriers as Skynet

> > and Federal Express to his employees' residences in Oklahoma City. He

then

> > implanted the devices in 200 women, who, according to Wood, learned

about

> > his augmentation business by word of mouth. He kept some implants on

hand

> > and sold the rest to other U.S. doctors who also performed breast

> > augmentation.

> >

> > On July 19, 1995, a federal grand jury returned a 15-count indictment

> > against Metcalf that included, among other things, charges of illegally

> > importing silicone gel-filled breast implants and laundering more than

> > $300,000 in proceeds.

> >

> > Metcalf pleaded guilty Nov. 14, 1995, to one count of violating the

> > Federal Food, Drug, and Cosmetic Act. The remaining charges were

dropped.

> >

> > According to Wood, the state of Oklahoma is investigating Metcalf for

> > possible improper medical practice. He also faces a number of

class-action

> > suits brought by his breast implant patients, who, according to Wood,

were

> > unaware that Metcalf was illegally importing the breast implants until

> > news of his indictment and arrest on July 26, 1995, became public.

> >

> > The seized implants remain in FDA's possession and will be destroyed.

> >

> > a Kurtzweil is a member of FDA's public affairs staff.

> >

> > -------

> > ------------------------------------------------------------------------

> > FDA Consumer magazine (July-August 1996)

> >

> >

> >

>

>