Silimed ordered to notify patients they were implanted with illegal devices

~~~ thanks Lynda for the heads up ~~~

http://www.fdanews.com/pub/ddl/30_37/industrynews/17424-1.html
Sept. 22, 2003
FDA TELLS FIRM TO NOTIFY PATIENTS IMPLANTED WITH ILLEGAL DEVICES 


Silimed, a Dallas-based manufacturer of breast implants and other
cosmetic plastic surgery products, has been ordered by the FDA to
notify implant recipients that they have been implanted with
unapproved devices.

http://www.fda.gov/foi/warning_letters/g4267d.htm

Via Federal Express



WARNING LETTER 

AUGUST 21, 2003


Robert A. Bishop, II
President
Silimed, Incorporated
11220 Grader Street, Suite 100
Dallas, Texas 75238

Dear Mr. Bishop:


The purpose of this Warning Letter is to inform you of objectionable
conditions found during a Food and Drug Administration (FDA)
inspection at your facility and to request a written response.

On January 13-29, 2003, Ms. Cynthia A. Harris and Mr. Phillip D.
Waldron, investigators from FDA's Dallas District Office, conducted an
inspection at Silimed, Inc. The purpose of the inspection was to
determine whether your activities as a sponsor of investigational
studies with significant risk devices, intended for use for [redacted]
and [redacted] complied with applicable FDA regulations.

FDA investigators conducted this inspection under a program designed,
in part, to ensure that data and information contained in applications
for an Investigational Device Exemption (IDE) are scientifically valid
and accurate. Another objective of this program is to ensure that
human subjects are protected from undue hazard or risk during the
course of scientific investigations

At the close of the inspection, the FDA investigators issued a Form
FDA-483, "Inspectional Observations," and discussed the findings with
you. The deviations listed below are not intended to be an
all-inclusive list of violations observed at your facility. As a
sponsor of investigational studies, it is your responsibility to
ensure that devices you ship and investigations you sponsor comply
with applicable FDA regulations. The following violations were
observed:

1. You distributed significant risk devices without an FDA approved
IDE or premarket approval application (PMA). Consequently, these
devices are adulterated under section 501(f)(1)(A) of the Act (21
U.S.C. 351(f)(1)(A)).

Silimed's records disclose that between October 2000 and January 2003,
Silimed sold at least 80 unapproved significant risk devices--
[redacted] - to at least 15 different hospitals or physicians
throughout the United States- The unapproved devices were implanted
without the knowledge or approval of the FDA, without proper
Institutional Review Board (IRB) oversight, and, in most cases,
without the patient knowing that the devices were unapproved and
investigational.

2.Failure to obtain IRB review and approvoal of Silimed [redacted]
under IDE [redacted] (21 CFR 56.103 and 21 cfr 812.42).

Silimed's records indicate that the company distributed more than 500
devices to at least 25 different medical establishments that did not
receive IRB approval before initiating their site investigations. Nine
of the medical establishments never received IRB review
and approval of the clinical investigation at their site.

3. Failure to ensure proper monitoring of the clinical investigation
and to secure prompt investigators' compliance with the
investigational plan and applicable FDA regulations (21 CFR 812.40 and
812.46).

As the sponsor, you are responsible for monitoring the investigators'
activities [21 CFR 812.40]. You are also responsible for securing
their compliance with the investigational plan, the requirements of
applicable FDA regulations, and any conditions of approval imposed by
FDA or the reviewing IRB [21 CFR 812.46].

Our inspection of the clinical investigation under IDE [redacted]
revealed a number of violations associated your commitments in the
IDE. The IDE monitoring plan states that the clinical monitor will
cover FDA regulations, protocol, IRB approval, case report forms,
record keeping requirements, administrative reports, and the adequacy
of facilities during a pre-investigational (study initiation) site
visit. Your monitoring procedures state that the monitor will ensure
that a valid investigator's agreement, confidentiality agreement,
financial disclosure, and IRB approval are in place before signing off
for the initial shipment of the device to a new (clinical)
investigator. There is no documentation of a study initiation visit to
[redacted], and [redacted]. There is no documentation of sign off by
the clinical monitor before the devices were shipped to the clinical
sites.

Furthermore, the 1DE monitoring plan requires the Clinical Monitor to
conduct monitoring visits at each investigational site. No other
sponsor's representative is identified as a site monitor. The only
records documenting visits by the Clinical Monitor were for seven of
60 clinical investigators' locations. Other records documented site
visits by contract sales representatives.

Written monitoring procedures state that monitoring activities are to
be documented in a designated format including use of the Site Visit
Monitoring Report and Monitoring Visit Observation Report. With the
exception of a site visit to the location of-by the Clinical Monitor,
the site visits to the other three investigators whose records were
reviewed by FDA were conducted by contract sales representatives and
not documented.

Records collected during the inspection indicate you were aware as
early as April 2002 that [redacted] in [redacted and early as March
2001 that [redacted] were noncompliant in their clinical
investigations. [redacted] failed to provide information regarding
follow-up visits of his 22 subjects enrolled between March 2001 and
August 2001. [redacted] failed to complete case histories of 66
subjects enrolled between November 21, 2000, and August 6, 2000.
However, you made no effort to secure compliance promptly with these
clinical investigators. You did not terminate[redacted] and [redacted]
until July 23, 2002. A sponsor who discovers that an investigator IS
not complying with the investigational plan, the requirements of 21
CFR Part 812, or other applicable FDA regulations shall promptly
either secure compliance or discontinue shipments of the device to the
investigator and terminate the investigator's participation in the
investigation [21 CFR 8 12.46]

4. Failure to maintain complete and current records relating to the
clinical investigation (21 CFR 812.140(b)(l) and 812.140(b)(3)]

Silimed failed to maintain correspondence with the monitors,
investigators, IRBs, and FDA [21 CFR 812.140(b)(l)]. Th e f u-m did
not have complete correspondence between the sponsor and clinical
investigators and between the monitors and clinical investigators.
Also, the firm did not have complete records of all progress reports
submitted to the reviewing IRBs and complete records of reports to the
FDA about clinical investigators using the device without obtaining
informed consent. Silimed also did not maintain complete financial
disclosure information for each clinical investigator [21 CFR
812.140(b)(3)].

5. Failure to prepare and submit complete, accurate, and timely
reports related to the clinical investigation [21 CFR 812.150(b)(5)
and 812.150(b)(8)]

Silimed failed to prepare and submit to FDA reports of investigators
using the investigational device without obtaining consent from
subjects. Your records contain instances where subjects were implanted
with device without signing form. For example, [redacted] implanted
the Silimed [redacted] into seven subjects between June and July 2000,
but the site did not receive IRB approval for the study until October
18, 2000. These incidents were not reported within the five working
days to the FDA upon discovery by the sponsor 121 CFR 812.150(b)(8)].
Silimed also failed to submit annual progress reports to FDA and the
reviewing IRB documenting these consent infractions and failure of the
site to obtain IRB approval [2 1 CFR 812.150(b)(5)].

FDA considers your activities to be serious violations of the law. The
introduction of adulterated devices is a violation of Section 301 (a)
of the Act (21 U.S.C. 33 1(a)). Further use of the unapproved devices
are violations of Section 301(q)( 1) of the Act (21 U.S.C. 33
1(q)(1)). Continuation of these activities may result in FDA taking
regulatory action without further notice. These actions include, but
are not limited to, seizure, injunction, civil money penalties, or
criminal prosecution.

Please respond to this letter in writinh within 15 days. Your response
should include distribution information for the[redacted] and any
other unapproved devices. This information should include the name,
address and phone number of practitioners and institutions receiving
the devices and the dates of shipment.

To protect the rights and welfare of the human subjects you implanted,
you must develop a corrective action plan that includes at a minimum,
notification of each recipient by certified mail that they were
implanted with an unapproved device, who to contact in the event of an
emergency, and where to report adverse events. Your corrective action
plan should be submitted to this office for approval before
implementation. Copies of all letters sent to implant recipients
should also be submitted to this office.

In addition, please submit a written corrective action plan that
includes documentation of the specific steps you have taken or will
take to correct and prevent the recurrence of similar violations in
current and future clinical investigations. Your response must include
timeframes for completion of corrective actions and copies of any
agreements with, and the qualifications of, any third-party auditors
or contractors you may choose to use.

We acknowledge receipt of your response to the FDA-483 dated March 13,
2003. We disagree with your assertion that the [redacted] is a custom
device and that you were acting as a contract manufacturer for
[redacted]. The custom device exemption of section 520(b) of the of
the Act (21 U.S.C. 360j(b)) extends a limited exemption to the
mandatory performance standard requirements of section 514 of the Act
(21 U.S.C. 360d) and the PMA requirements of section 515 of the Act
(21 U.S.C. 360e) to devices that meet a narrow and specific set of
statutory requirements. In addition, by regulation FDA has extended
the concept of a custom device exemption to IDEs through provisions
found at 21 CFR 812.2(c)(7) and 812.3(b). Among those requirements, a
custom device must be intended for use by an individual patient named
in a prescription and made in a special form for that patient or must
be intended to meet the special needs of a particular health
professional in the course of his professional practice. A special
need is one that relates to unusual anatomical features of the
individual physician for whom the device was produced, or to special
needs of his or her practice that are not shared by other health
professionals of the same specialty. A device that meets a need that
is shared by others in the field is a device that can be tested
through clinical investigations and can be subject to the PMA
requirements in order to ensure that it is safe and effective. These
requirements are to be narrowly construed and do not create an
exemption from otherwise applicable statutory requirements.

Custom device exemptions are not mandated by statute. Neither the IDE
nor premarket notification regulations exempt from its respective
requirements a broader category of devices than 520(b) of the Act
exempts from the requirements of a PMA. Consequently, a device that
could not qualify for a custom device exemption under section 520(b)
also can not qualify for an exemption from IDE requirements under 21
C.F.R. 812.2(c)(7).

The [redacted] devices distributed by Silimed to different hospitals,
physicians, and/or medical device distributors do not meet the
criteria for a custom device explained above and, therefore, are not
exempt from compliance with the premarket notification requirements,
the investigational device exemption regulations, or premarket
approval requirements. Your other responses lack appropriate detail
and, in some cases, indicate a fundamental lack of understanding
regarding a sponsor's responsibilities when conducting a clinical
trial.

You should direct your response to the Food and Drug Administration,
Center for Devices and Radiological Health, Office of Compliance,
Division of Bioresearch Monitoring, Program Enforcement Branch I
(HFZ-3 11I), 2098 Gaither Road, Rockville, Maryland 20850. Attention:
Kevin M. Hopson, Consumer Safety Officer. Please direct all questions
concerning this matter to Mr. Hopson at (301) 594-4720, ext. 128.

A copy of this Warning Letter was sent to the Food and Drug
Administration's Dallas District Office, 4040 North Central
Expressway, Suite 300, Dallas, Texas 75204. We request that a copy of
your response also be sent to that office.

Sincerely yours,

/s/ 

Michael E. Marcarelli for 

Timothy A. Ulatowski 

Director