Medical Devices; Reclassification of Suction Lipoplasty System for Aesthetic Body Contouring

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

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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