[Federal Register Volume 61, Number 220 (Wednesday, November 13, 1996)]
[Notices]
[Pages 58195-58199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29066]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88P-0439]
Medical Devices; Reclassification of Suction Lipoplasty System
for Aesthetic Body Contouring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of panel recommendation.
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SUMMARY: The Food and Drug Administration (FDA) is issuing for public
comment the recommendation of the General and Plastic Surgery Devices
Panel (the Panel) to reclassify the suction lipoplasty system for
aesthetic body contouring from class III to class II. The Panel made
this recommendation after reviewing the reclassification petition
submitted by the American Society for Aesthetic Plastic Surgery (ASAPS)
and other publicly available information. FDA is also issuing for
public comment its tentative findings on the Panel's recommendation.
After considering any public comments on the Panel's recommendation and
FDA's tentative findings, FDA will approve or deny the reclassification
petition by order in the form of a letter to the petitioner. FDA's
decision on the reclassification petition will be announced in the
Federal Register.
DATES: Written comments by February 11, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices
and Radiological Health (HFA-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION: On December 28, 1988, ASAPS submitted a
petition under section 513(e) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360c(e)), requesting that the suction
lipoplasty system intended for surgical use in aesthetic body
contouring, be reclassified from class III into class II. The major
components of this system, the cannula (a manual surgical instrument
for general use (21 CFR 878.4800)), and the suction pump (powered
suction pump (21 CFR 878.4780)) when intended for certain uses other
than suction lipoplasty procedures are classified in class I and class
II, respectively. However, when these devices, individually labeled or
combined into a system, are intended for use in aesthetic body
contouring, they are automatically classified into class III under
section 513(f)(1) of the act.
Section 513(f)(2) of the act provides that FDA may initiate the
reclassification of a device classified into class III under section
513(f)(1) of the act, or the manufacturer or importer of a device may
petition the agency to reclassify the device into class I or class II.
FDA's regulations in 21 CFR 860.134 set forth the procedures for the
filing and review of a petition for reclassification of such class III
devices. In order to change the classification of the suction lipectomy
system for use in aesthetic body contouring, it is necessary that the
proposed new class has sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
Under the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
310-394), (as amended by the Medical Device amendments of 1976 (the
amendments) (Pub. L. 94-295), class II devices were defined as those
devices for which there is insufficient information to show that
general controls alone will ensure safety and effectiveness, but there
is sufficient information to establish that performance standards would
provide a reasonable assurance of safety and effectiveness of the
device. In the time that has passed since the submission of the
petition and the Panel meeting, the definition of class II devices has
been amended by the Safe Medical Devices Act of 1990 (the SMDA). Under
the SMDA, class II devices are those devices for which there is
insufficient information to show that general controls alone will
ensure safety and effectiveness, but there is sufficient information to
establish special controls to provide such assurance, including the
issuance of a performance standard, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the agency deems
necessary (section 513(a)(B) of the act).
It is the agency's position that is not necessary to obtain a new
reclassification recommendation from a
[[Page 58196]]
Panel which had recommended reclassification into class II prior to the
SMDA. If a Panel recommended that a device be reclassified from class
III to class II under the 1976 definition of class II, which included
only performance standards as a class II control, clearly the Panel's
recommendation for class II status would not change if controls in
addition to performance standards could be added.
I. Background
In 1983 three firms submitted four premarket notifications to FDA
under section 510(k) of the act (21 U.S.C. 360(k)) advising the agency
of their intentions to place into commercial distribution either the
suction cannula or the powered suction pump for use in suction
lipoplasty for aesthetic body contouring. FDA determined that neither
the suction cannula nor the powered suction pump for aesthetic body
contouring was substantially equivalent to any preamendments device,
nor was either device substantially equivalent to any postamendments
device that had been classified into class I or class II for use in
suction lipectomy for aesthetic body contouring. Accordingly, both
devices were classified into class III under section 513(f)(1) of the
act, and neither device could be placed in commercial distribution for
use in suction lipoplasty for aesthetic body contouring unless it was
reclassified under section 513(f)(2), or subject to an approved
premarket approval application under section 515 of the act (21 U.S.C.
360e).
Subsequently, ASAPS initiated a clinical trial to identify the
risks associated with suction lipoplasty procedures and to determine
the relationship of the risks to characteristics of suction lipoplasty
devices and thereby develop measures to minimize or control the risks
(Ref. 1). After completing the clinical trial, ASAPS petitioned FDA to
reclassify suction lipoplasty systems for use in aesthetic body
contouring from class III into class II (Ref. 1). Consistent with the
act and applicable regulations, the agency referred the petition to the
Panel for its recommendation on the requested change in classification.
II. Recommendation of the Panel
The Panel met on January 26, 1989, in a public meeting and on March
10, 1989, via a telephone conference to discuss the suction lipoplasty
systems intended for use in aesthetic body contouring. During the
January 6, 1989, meeting, the Panel determined that additional data and
information were indicated and that another panel meeting would be
necessary to allow the Panel to address specific issues concerning the
reclassification of the suction lipoplasty systems (Ref. 2). The Panel
noted that the suction lipoplasty system is indicated for aesthetic
body contouring (Ref. 2, p. 52) and is not intended to be a substitute
for a weight reduction regimen. On March 10, 1989, after considering
the device components and accompanying surgical risks as addressed in
the petition and literature, the Panel recommended that the suction
lipoplasty systems intended for aesthetic body contouring be
reclassified from class III into class II (Ref. 3, p. 95). The Panel
also recommended that FDA assign a high priority for the development of
a performance standard for the generic type device.
III. Device Description
The suction lipoplasty system consists of a powered suction pump
(containing a microbial filter on the exhaust and a microbial in-line
filter in the connecting tubing between the collection bottle and the
safety trap), collection bottle, cannula, and connecting tube. The
microbial filters, tubing, collection bottle, and cannula must be
sterile and capable of being changed between patients. The powered
suction pump has a motor with a minimum of 1/3 horsepower, a variable
vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to
regulate the vacuum with accompanying vacuum gauges, single or double
rotary vane (oil or oil-less), single or double diaphragm, single or
double piston, and a safety trap (Ref. 4). The pump meets the voluntary
Underwriters Laboratories (UL) UL-455 Standards for Medical and Dental
Equipment (Ref. 5). The collection bottle is calibrated to permit
precise continual monitoring of the amount of material being removed
from the patient. The cannulas are composed of biocompatible material
such as plastic or surgical grade stainless steel with various
dimensions and configurations determined by the particular application
or surgical site and preference of the individual surgeon (Refs. 4, 6,
and 7). The connecting tubing has an internal diameter appropriate to
the size of the cannula handle, generally 7.5 to 12.5 millimeters. The
tubing is able to withstand the amount of negative pressure created by
the pump without collapsing.
The device is used in the clinical field of plastic surgery for the
purpose of aesthetic body contouring.
IV. Summary of Reasons for the Recommendation
After reviewing the data and information contained in the petition
and provided by FDA, and after consideration of the open discussions
during the Panel meetings and the Panel members' personal knowledge of
and clinical experience with the device system, the Panel gave the
following reasons in support of its recommendation to reclassify the
generic type suction lipoplasty system for use in aesthetic body
contouring from class III into class II:
(1) General controls by themselves are insufficient to provide
reasonable assurance of the safety and effectiveness of the device.
(2) There is sufficient publicly available information to establish
a performance standard to provide reasonable assurance of the safety
and effectiveness of the device for its intended use.
(3) There is sufficient publicly available information to
demonstrate that the risks to health and the performance parameters of
the device have been characterized and that the relationship of these
risks and performance parameters have been evaluated (Refs. 8, 11, and
12).
(4) Sufficient voluntary standards exist to reasonably assure the
design and performance of the device system (Refs. 5, 13, 14, 15, 16,
and 26).
The Panel believed that current and any subsequent manufacturer of
the suction lipoplasty system can comply with these voluntary standards
and a performance standard; that FDA can assure the safety and
effectiveness of device systems made by new manufacturers through
premarket notification procedures under section 510(k) of the act; and
that a regulatory level of class III is unnecessary to provide a
reasonable assurance of safety and effectiveness.
V. Risks to Health
The Panel determined that the foreseeable risks to health
associated with the use of the suction lipoplasty system fall into two
categories: (1) Those related to the device system that include the
potential of infection of a subsequent patient resulting from the
backflow of contaminated material trapped by the in-line filter during
the preceding procedure, and (2) those related to the suction procedure
that include tissue trauma (i.e., pain, nerve and blood vessel damage,
hypesthesia, and hemorrhage). The degree of tissue trauma is believed
to be related to the amount of vacuum applied and the type
[[Page 58197]]
of cannula used during the procedure (Refs. 10, 17, 18, and 19).
After reviewing the Panel meeting transcripts, the petition, and
the relevant literature, FDA identified other potential risks which
include airborne bacterial or viral contamination of other patients and
hospital personnel resulting from inefficient or overused in-line
filters, patient bio-incompatibility to materials, and infection
resulting from improper sterilization or practitioner handling.
Several of the procedure-related risks reported in the literature
(fat embolism, venous thrombosis, hematoma/seroma, pain, infection,
necrosis/skin slough, edema, hypovolemia/hypotension, and potential
death (Refs. 8, 11, 20, 21, 22, and 23)) were not observed in the
petitioner's clinical studies and other procedure-related risks were
reduced when the surgical procedure was performed by adequately trained
surgeons on properly selected patients.
In general, the best candidates for liposuction are healthy
individuals who have concentrated areas of fat and firm, elastic
skin. Age is usually a criterion for a healthy patient. However,
after age 55, some patients lose skin elasticity and will not
achieve the same good results as a younger patient.
Liposuction is not recommended for patients with heart or lung
diseases, poor blood circulation, diabetes, or those who have had
recent surgery near the area of fat to be suctioned. Patients who
are obese with diffuse areas of fat are not considered ideal
candidates because of a greater risk of complications. However, in
some cases, a series of carefully controlled procedures may be an
effective adjunct to a weight-loss program.
(Ref. 24)
VI. Benefits
Suction lipoplasty systems provide benefits to patients by
effectively performing aesthetic body contouring. The benefits of these
devices are probably best characterized in terms of patient
satisfaction. The ASAPS study reported 56 percent of patients being
very satisfied, 34 percent satisfied, and 6 percent not satisfied. Two
other large studies reported overall satisfaction rates of 88 and 76
percent, respectively (Refs. 8 and 9). Both studies found
dissatisfaction rates highest in patients who had undergone liposuction
of the buttocks. From the physicians' survey, review of the long-term
results reveal that less than half of the respondents reported totally
permanent results. Twenty nine percent reported fat ``regrowth'' as
minimal and 62 percent were satisfied with the results.
VII. Summary Data Upon Which the Panel Recommendation is Based
During its review and discussion of the petition, the Panel paid
close attention to the potential risks and benefits to health
associated with the use of the suction lipoplasty system and concluded
that the data and information contained in the petition and presented
by FDA demonstrated that the risks to health associated with this
system could be adequately controlled (Ref. 1). The Panel relied on the
following information in recommending that the suction lipoplasty
system for aesthetic body contouring be class II devices.
A 1988 ASAPS multicenter study (Ref. 1) provided some perspective
of the above mentioned risks and complications. The study, using 2
different suction pumps and connective tubing and 8 different cannulas,
reported that of the 113 patients in whom 189 procedures had been
performed, where the amount of fluid aspirated ranged from 15 to 4,700
cubic centimeters per patient, there were no complications, undesired
sequelae or health problems directly related to the device system used
to perform liposuctions (Ref. 1, p. 24). The study also noted no
mortality or episodes of shock, although 1 patient developed
subcutaneous emphysema of the neck that was determined to be anesthesia
related and 39 patients required postoperative transfusions. Other
reported complication rates were hypesthesia, 46.6 percent; pain, 18.6
percent; change in pigmentation, 10.6 percent; and scarring (thickening
of the skin) during the immediate postoperative period, 9.9 percent.
Additional complications which occurred in less than 5 percent of
patients include asymmetry, waviness, insufficient fat removal,
hematoma, excessive fat removal, and edema. Most of these complications
improved or resolved with time resulting in an overall complication
rate of 4.1 percent. Many of the items listed as complications in the
study would be classified as undesirable sequela by other authors (Ref.
1, p. 24).
A 1987 American Society of Plastic and Rescontructive Surgery
(ASPRS) task force studied the safety of liposuction. Eleven deaths and
nine nonfatal serious complications over a 5-year period (an estimated
100,000 cases) were documented (Ref. 12).
Two other major studies on liposuction devices have been completed
since the January 26, 1989, Panel recommendation. In 1989, a national
survey of plastic surgeons was conducted. The findings of this survey
identified a liposuction complication rate of 0.1 percent with 2 deaths
among the 75,591 liposuction procedures analyzed in the survey. One
death was caused by fat embolism and the other death by pulmonary
thromboembolism. Twenty-five cases of deep venous thrombosis, 10
transfusion complications, 9 cases of pulmonary thromboembolism, 5
cases of major skin loss, 1 stroke, and 1 nonlethal fat embolus were
reported (Ref. 11).
In 1990, the Fornebu Clinic in Norway conducted a study involving
3,511 liposuctions in 2,009 patients. It reported excessive bleeding in
eight patients and anesthesia related complications in nine patients;
however, no deaths, thromboembolic events, fat emboli or cardiovascular
complications were reported (Ref. 8). Infection, an issue of particular
concern to the Panel and to FDA, occurred in only 1 of the 2,009
patients. The low incidence of infection associated with liposuction
devices is confirmed and supported by several other reports in which
the infection rate was less than 1 percent (Refs. 7, 8, 10, and 25).
VIII. Panel Recommendation
The Panel concluded that the incidence of infections and other
complications associated with liposuction using the suction lipoplasty
system for aesthetic body contouring can be controlled by proper
patient selection, utilization of the proper surgical technique, and
restricting the use of the device to trained and experienced
practitioners.
Focusing on other potential problems and performance aspects of the
device system, the Panel considered the issues of electrical
malfunctions; bacterial, viral, or oil contamination of the operating
room; bioincompatibility of materials; reflux of possible contaminated
aspirated material; and product labeling.
Regarding potential electrical malfunctioning of the components and
properties of the device, the Panel believed that the UL-544 Standard
for Medical and Dental Equipment (Ref. 2) can provide the necessary
provisions to control the potential electrical hazards associated with
the use of the suction pump. Likewise, the Panel believed that the
American Society for Testing Materials (ASTM) F 960-86 Standard
Specification for Medical and Surgical Suction and Drainage Systems can
control the potential risk of leakage, risk of filtration, and
implosion of the contaminants into the operating room by emissions from
the exhaust port of the pump. Proper sterilization of the cannula and
tubing can control the risk
[[Page 58198]]
of infection as indicated by the low rate of infection reported in the
literature (Ref. 1, p. 29). The risk of oil vapor leakage can be
reduced by properly maintaining the pump in oil based aspirators (Refs.
1 and 4). The Panel noted that there are no reports of viral
transmissions to operating room personnel from aerosolization of
aspirate (Ref. 4).
A major concern to the Panel was the reflux of possibly
contaminated aspirated material from the collection bottle into the
sterile surgical field. They concluded that filters and/or valves can
minimize the potential risk of bacterial contamination of the cannula,
surgical field, and operating room air.
The Panel believed the biocompatibility of materials used to
manufacture the cannula can be assessed by voluntary standards
established by ASTM (Ref. 13), United States Pharmacopeia (USP) (Ref.
14), and by methods described in Tripartite Biocompatibility Guidance
for Medical Devices (Ref. 26), and that these test methods will provide
reasonable assurance that the materials used to manufacture the device
system, as well as any residues remaining on the devices after
manufacturing, are not toxic and that the system is biocompatible. The
Panel also believed that when the device is manufactured of materials
that meet the specifications of existing voluntary standards, a
biocompatible cannula can be produced thereby providing reasonable
assurance of safety and effectiveness with respect to biocompatibility.
The Panel believed that device labeling should reflect the nature
of the device as it relates to the intended use and should include
appropriate directions for use, warnings, and precautions, based upon
current scientific knowledge. The Panel further believed that the
labeling should be accessible to physicians and patients.
In summary, the Panel believed that, based on publicly available
valid scientific evidence, class II controls can provide reasonable
assurance that the suction lipoplasty system is safe and effective for
use in aesthetic body contouring. The Panel specified that the device
conform to the provisions similar to those in the Tripartite
Biocompatibility Guidance for Medical Devices, the above voluntary
standards established by UL, ASTM, the Canadian Standards Association
(CSA), the International Organization for Standardization (ISO), and
USP, and specific labeling which identifies the appropriate patient
selection criteria and surgeon training. The panel also recommended the
issuance of a performance standard on a high priority basis.
IX. FDA's Tentative Findings
FDA believes that the data provided by the petitioners and others
constitute valid scientific evidence demonstrating that the regulatory
controls of class II in combination with class I are sufficient to
provide reasonable assurance of the safety and effectiveness of the
generic type lipoplasty system as identified in section III. of this
document. FDA tentatively agrees with the recommendation of the Panel
that the suction lipoplasty system for aesthetic body contouring and
substantially equivalent devices of this generic type should be
reclassified from class III into class II. The agency has identified
the special controls as the four following voluntary standards:
International Organization for Standardization (ISO) 10079-1, Medical
Suction Equipment, Part 1, Electrically Powered suction Equipment--
Safety Requirements, 1993 (Ref. 15); Canadian Standards Association
(CSA), Standard Z168.11-94, Vacuum Devices Used for Suction and
Drainage, 1994 (Ref. 16); Clinical Practice Guidelines, Plastic and
Maxillofacial Surgery, American Society of Plastic and Reconstructive
Surgeons, Chapter L: Localized Adiposity, September 1993 (Ref. 27);
International Standard ISO-10993 Biological Evaluation of Medical
Devices Part I Evaluation and Testing, 1995 (Ref. 28); and the
inclusion of the following labeling statements to provide reasonable
assurance of the safety and effectiveness of the suction lipoplasty
system:
(1) This device is designed to contour the body by removing
localized deposits of excess fat through small incisions.
(2) Use of this device is limited to those physicians who, by means
of residency training or sanctioned continuing medical education, have
demonstrated proficiency in suction lipoplasty.
(3) This device will not, in and of itself, produce significant
weight reduction.
(4) This device should be used with extreme caution in patients
with chronic medical conditions such as diabetes, heart or lung
disease, circulatory diseases, or obesity.
(5) Results of this procedure will vary depending upon patient age,
surgical site, and experience of the surgeon.
(6) Results of this procedure may or may not be permanent.
(7) The amount of fat removed should be limited to that necessary
to achieve a desired cosmetic effect.
(8) Loss of blood and fluid is predictable based on suction volume.
Capability of providing adequate, timely replacement of these
components is essential for patient safety.
(9) All reusable components of the device must be sterilized
between patients and all disposable components replaced.
FDA does not believe that the performance standard recommended by
the Panel is necessary because the voluntary standards listed above
will provide a reasonable assurance of safety and effectiveness for the
suction lipectomy system.
Consistent with the purpose of the act, class II controls as
identified above and as defined by section 513(a)(1)(B) of the act are
sufficient to provide reasonable assurance of the safety and
effectiveness of the suction lipoplasty system.
X. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
XI. Analysis of Impacts
FDA has examined the impacts of this proposed action under
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The agency
believes that this proposed action is consistent with the regulatory
philosophy and principles identified in the Executive Order. In
addition, the proposed action is not a significant regulatory action as
defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of devices relieve
manufacturers of the cost of complying with the premarket approval
requirements of section 515 of the act, and may permit small potential
competitors to enter the marketplace by lowering their costs, the
agency certifies that this proposed action would not have a significant
economic impact on
[[Page 58199]]
a substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
XII. References
The following references have been placed on display in the
Documents Management Branch (address above) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Reclassification Petition for the Suction Lipectomy Systems
for Aesthetic Body Contouring, submitted by American Society for
Aesthetic Surgery, December 28, 1989.
2. Transcript of the General and Plastic Surgery Devices Panel
Meeting, January 26, 1989.
3. Transcript of the General and Plastic Surgery Devices Panel
Meeting, March 10, 1989.
4. Pitman, G. H., ``Instrumentation,'' Liposuction and Aesthetic
Surgery, Quality Medical Publishing Inc., St. Louis, MO, Part I,
2:31-36.
5. Underwriters Laboratories, UL-544, Standard for Medical and
Dental Equipment, 1976, Reprinted 1985.
6. Illouz, Y. G., ``Illouz's Technique of Body Contouring by
Lipolysis,'' Clinics in Plastic Surgery, 11:409-417, 1984.
7. Kesselring, U. K., ``Body Contouring with Suction
Lipectomy,'' Clinics in Plastic Surgery, 11:393-498, 1984.
8. Dillerud, E., ``Suction Lipoplasty, A Report on
Complications, Undesired Results, and Patient Satisfaction Based on
3,511 Procedures,'' Plastic and Reconstructive Surgery, 88:239-246,
August 1991.
9. Dillerud, E., and L. L. Haheim, ``Long-term Results of Blunt
Suction Lipectomy Assessed By Questionnaire Survey,'' Plastic and
Reconstructive Surgery, 92:35-42, July 1993.
10. Dolsky, R. L., J. Newman, J. R. Fetzek, et al.,
``Liposuction History, Techniques and Complications,'' Dermatology
Clinics of North America, 5:313-333, 1987.
11. Teimourian, B. and W. B. Rogers, ``A National Survey of
Complications Associated with Suction Lipectomy: A Comparative
Study,'' Plastic and Reconstructive Surgery, 84:628-631, 1989.
12. Fredricks, S., ``Five-year Updated Evaluation of Suction-
assisted Lipectomy,'' ASPRS Ad Hoc Committee on New Procedures,
September 30, 1987.
13. Annual Book of American Society for Testing and Materials
Standards, Medical Devices, vol. 13.01, 1088.
F 639-79 Standard Specification for Polyethylene Plastics for
Medical Applications.
F 665-80 Standard Classification for Vinyl Chloride Plastics
Used in Biomedical Application.
F 719-81 Standard Practice for Testing Biomaterials in Rabbits
for Primary Skin Irritation.
F 720-81 Standard Practice for Testing Guinea Pig Maximization
Test.
F 748-87 Standard Practice for Selecting Generic Biological Test
Method for Materials and Devices.
F 749-87 Standard Practice for Evaluating Material Extracts by
Intracutaneous Injection in the Rabbit.
F 750-87 Standard Practice for Evaluating Material Extracts by
Systemic Injection in the Mouse.
F 813-83 Standard Practice for Direct Cell Culture Evaluation of
Materials for Medical Devices.
F 960-86 Standard Specification for Medical and Surgical Suction
and Drainage Systems.
14. United States Pharmacopeia XXI, Biological Tests--Plastics.
15. ISO (International Organization for Standardization) 10079-
1, Medical Suction Equipment, Part I, Electrically Powered Suction
Equipment--Safety Requirements, 1993.
16. CSA (Canadian Standards Association), Standard Z168.11-94,
Vacuum Devices Used for Suction and Drainage, 1994.
17. Grazer, F. M., ``Suction-Assisted Lipectomy: Its
Indications, Contraindications, and Complications,'' Year Book
Medical Publishers, 1984.
18. Ersek, R. A., J. Zambrona, G. S. Surak, et al., ``Suction-
assisted Lipectomy for Correction of 202 Figure Faults in 101
Patients: Indications, Limitations, and Applications,'' Plastic and
Reconstructive Surgery, 78:615-626, 1986.
19. Hetter, G. P., ``Optimum Vacuum Pressures for Lipolysis,''
Aesthetic Plastic Surgery, 8:23-26, 1984.
20. Christman, K. D., ``Death Following Lipectomy and Tissue,''
``Neither Panacea of Humbug,'' Postgraduate Medicine, 75:124, 126,
128, 1984.
21. Courtiss, E. H., ``Suction Lipectomy: A Retrospective
Analysis of 100 Patients,'' Plastic and Reconstructive Surgery,
73:780-796, 1984.
22. Badran, H. A., K. Z. Kodeara, and M. H. Mabrouk, ``Blood
Conservation in Massive Suction Lipectomy,'' Plastic and
Reconstructive Surgery, 92:1298-1304, 1993.
23. Hunter, G. R., R. O. Crapo, and T. R. Broadbent, ``Pulmonary
Complications Following Abdominal Lipectomy,'' Plastic and
Reconstructive Surgery, 71:809-817, 1983.
24. Backgrounder, ``Liposuction'' American Society of Plastic
and Reconstructive Surgeons, July 1994.
25. Pitman, G. H., and B. Teimourian, ``Suction Lipectomy:
Complications and Results by Survey,'' Plastic and Reconstructive
Surgery, 76:65-72, 1985.
26. Tripartite Biocompatibility Guidance for Medical Devices,
September 1986.
27. Clinical Practice Guidelines, Plastic and Maxillofacial
Surgery, American Society of Plastic and Reconstructive Surgeons,
Chapter L: Localized Adiposity, September 1993.
28. International Standard ISO-10993 Biological Evaluation of
Medical Devices Part I Evaluation and Testing, 1995.
XIII. Request for Comments
Interested persons may, on or before February 11, 1997, submit to
the Dockets Management Branch (address above) written comments
regarding this document. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 6, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-29066 Filed 11-12-96; 8:45 am]
BILLING CODE 4160-01-F
