Gastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 97N-0481]

Gastroenterology-Urology Devices: Reclassification of the Penile

Rigidity Implant

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to

reclassify the penile rigidity implant, a medical device intended to

provide penile rigidity in men diagnosed as having erectile

dysfunction, from class III to class II. The special controls

identified in this proposed rule are the physician and patient

labeling, biocompatibility testing, mechanical reliability performance

testing, clinical testing, and sterilization requirements described in

FDA's guidance document entitled ``Guidance for the Content of

Premarket Notifications for Penile Rigidity Implants.'' This

reclassification is being proposed on the agency's own initiative based

on new information. This action is being taken under the Federal Food,

Drug, and Cosmetic Act (the act), as amended by the Medical Device

Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices

Act of 1990 (the SMDA).

DATES: Written comments by March 16, 1998. FDA proposes that any final

regulation based on this proposal become effective 30 days after its

date of publication in the Federal Register.

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: John H. Baxley, Center for Devices and

Radiological Health (HFZ-470), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

The act, as amended by the 1976 amendments (Pub. L. 94-295) and the

SMDA (Pub. L. 101-629), established a comprehensive system for the

regulation of medical devices intended for human use. Section 513 of

the act (21 U.S.C. 360c) established three categories (classes) of

devices, depending on the regulatory controls needed to provide

reasonable assurance of their safety and effectiveness. The three

categories of devices are class I (general controls), class II (special

controls), and class III (premarket approval).

Under section 513 of the act, devices that were in commercial

distribution before May 28, 1976 (the date of enactment of the

amendments), generally referred to as preamendments devices, are

classified after FDA has: (1) Received a recommendation from a device

classification panel (an FDA advisory committee); (2) published the

panel's recommendation for comment, along with a proposed regulation

classifying the device; and (3) published a final regulation

classifying the device. FDA has classified most preamendments devices

under these procedures.

Devices that were not in commercial distribution prior to May 28,

1976, generally referred to as post amendment devices, are classified

automatically by statute (section 513(f) of the act) into class III

without any FDA rulemaking process. Those devices remain in class III

and require premarket approval, unless and until FDA issues an order

finding the device to be substantially equivalent, under section 513(i)

of the act, to a predicate device that does not require premarket

approval. The agency determines whether new devices are substantially

equivalent to previously offered devices by means of premarket

notification procedures in section 510(k) of the act (21 U.S.C. 360(k))

and 21 CFR part 807 of the regulations.

A preamendments device that has been classified into class III may

be marketed, by means of premarket notification procedures, without

submission of a premarket approval application (PMA) until FDA issues a

final regulation under section 515(b) of the act (21 U.S.C. 360e(b))

requiring premarket approval. Section 515(b) of the act describes a two

step regulatory process. A notice of proposed rulemaking in the Federal

Register, which includes the proposed regulation, proposed findings of

risks and benefits of the device, an opportunity for the submission of

comments and an opportunity to request reclassification, is followed by

the final rule which issues the regulation.

In 1990, the SMDA added section 515(i) to the act. This section

requires FDA to issue an order to manufacturers of preamendment class

III devices for which no final regulation requiring the submission of

PMA's has been issued to submit to the agency a summary of, and a

citation to any information known or otherwise available to them

respecting such devices, including adverse safety and effectiveness

information which has not been submitted under section 519 of the act

(21 U.S.C. 360i). Section 519 of the act requires manufacturers,

importers, distributors and device user facilities to submit adverse

event reports of certain device-related events. Section 515(i) of the

act also directs FDA to either revise the classification of the device

into class I or class II or require the device to remain in class III

and establish a schedule for the issuance of a rule requiring the

submission of PMA's for those devices remaining in class III.

[[Page 65771]]

In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced

its strategy and made available a document setting forth its strategy

for implementing the provisions of the SMDA that require FDA to review

the classification of preamendment class III devices. In accordance to

this plan, the agency divided preamendment class III devices into the

following three groups: Group 1 devices are devices that FDA believes

raise significant questions of safety and/or effectiveness, but are no

longer used or are in very limited use. Group 2 devices are devices

that FDA believes have a high potential for being reclassified into

class II. Group 3 devices are devices that FDA believes are currently

in commercial distribution and are not likely candidates for

reclassification. FDA also announced its intent to call for submission

of PMA's for the 15 highest priority devices in Group 3, and for all

Group 1 devices. The agency also announced its intent to issue an order

under section 515(i) of the act for the remaining Group 3 devices and

for all of the Group 2 devices.

In the Federal Register of August 14, 1995 (60 FR 41984), FDA

published two orders for Certain Class III Devices; requiring the

submission of safety and effectiveness information in accordance with

the Preamendments Class III Strategy for implementing section 515(i) of

the act. Each of the orders described in detail the format for

submitting the type of information required by section 515(i) of the

act so that the information submitted would clearly support

reclassification or indicate that a device should be retained in class

III. The orders also scheduled the required submissions in groups of

nine devices at 6-month intervals beginning with August 14, 1996. The

device proposed in this regulation for reclassification was included in

the August 14, 1995, order on Group 2 devices (Docket No. 94N-0417).

Reclassification of classified preamendments devices is governed by

section 513(e) of the act. This section provides that FDA may, by

rulemaking, reclassify a device (in a proceeding that parallels the

initial classification proceeding) based upon ``new information.'' The

reclassification can be initiated by FDA or by the petition of an

interested person. The term ``new information,'' as used in section

513(e) of the act, includes information developed as a result of a

reevaluation of the data before the agency when the device was

originally classified, as well as information not presented, not

available, or not developed at that time. (See, e.g., Holland Rantos v.

United States Department of Health, Education, and Welfare, 587 F.2d

1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th

Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously before the agency is an

appropriate basis for subsequent regulatory action where the

reevaluation is made in light of changes in ``medical science.'' (See

Upjohn v. Finch, supra, 422 F.2d at 951.) However, regardless of

whether data before the agency are past or new data, the ``new

information'' on which any reclassification is based is required to

consist of ``valid scientific evidence'' as defined in section

513(a)(3) of the act and 21 CFR 860.7(c)(2). FDA relies upon ``valid

scientific evidence'' in the classification process to determine the

level of regulation for devices. For the purpose of reclassification,

the valid scientific evidence upon which the agency relies must be

publicly available. Publicly available information excludes trade

secret and/or confidential commercial information, e.g., the contents

of PMA's. (See section 520(c) of the act (21 U.S.C. 360j(c)).)

II. Regulatory History of the Device

In the Federal Register of November 23, 1983 (48 FR 53012 at

53023), FDA issued a final rule classifying the penile rigidity implant

into class III (21 CFR 876.3630). The preamble to the proposal to

classify the device (46 FR 7578, January 23, 1981) included the

recommendations of the Gastroenterology and Urology Devices Advisory

Panel and the General and Plastic Surgery Devices Advisory Panel (the

Panels), FDA advisory committees, which met regarding the

classification of the device. The Panels both recommended that the

device be classified in class II, listing poor tissue compatibility,

tissue trauma, and device structural problems as potential risks of the

device and citing that general controls and performance standards would

provide reasonable assurance of the safety and effectiveness of the

device.

FDA disagreed with the Panels' recommendations and proposed that

the penile rigidity implant be classified into class III. The proposal

stated that the agency believed that insufficient information existed

to determine that general controls would provide reasonable assurance

of safety and effectiveness of the device, or to establish a

performance standard to provide this assurance. The proposal stated

that premarket approval is necessary for this device because it

presents a potential unreasonable risk of injury due to: (1) Adverse

tissue reaction if the materials used in the construction of the device

are not biocompatible; (2) infection resulting from defects in the

design, construction, packaging, or processing of the device; (3)

urinary retention if the prosthesis compresses the urethra; and (4)

erosion or malfunction if the implant is improperly sized or

mechanically breaks. In support of its proposal to strengthen

regulatory surveillance of the device, FDA cited references supporting

the proposed classification.

In the Federal Register of April 7, 1981 (46 FR 20687), FDA

reopened the comment period for the proposed regulation classifying

this device for an additional 60 days. This addition 60-day comment

period was established because the proposed classification regulation

for the penile rigidity implant stated incorrectly that the

Gastroenterology and Urology Devices Advisory Panel recommended that

the device be classified into class III, rather than class II. In the

April 7, 1981 notice, FDA announced that on April 13, 1981, a meeting

of the Panel would be held. During this meeting, the Panel reviewed all

comments, and again recommended that the penile rigidity implant be

classified into class II. No other comments were received during the

remainder of the comment period. Again, FDA disagreed with the Panel's

recommendation and proposed that the penile rigidity implant be

classified into class III. FDA searched the published literature and

further documented the potential risks to health resulting from

silicone implants, such as silicone particle migration and allergic or

adverse tissue reaction.

The preamble to the November 23, 1983 (48 FR 53012), final rule

classifying the device into class III advised that the earliest date by

which PMA's for the device could be required was June 30, 1986, or 90

days after issuance of a rule requiring premarket approval for the

device, whichever occurs later.

In the Federal Register of May 6, 1994, FDA categorized the penile

rigidity implant as a Group 2 device, which FDA believes has a high

potential for being reclassified into class II. The agency also

announced its intent to issue an order under section 515(i) of the act

for Group 2 devices.

In the Federal Register of August 14, 1995 (60 FR 41984 at 41986),

FDA published an order requiring manufacturers of penile rigidity

implants to submit safety and effectiveness information in accordance

with the Preamendments Class III Strategy for implementing section

515(i) of the act. On August 14, 1996, two

[[Page 65772]]

summaries of safety and effectiveness information were submitted to the

agency (Refs. 39 and 40). These summaries recommended that the penile

rigidity implant be reclassified into class II and provide information

to assist FDA in reclassifying this device.

In accordance with sections 513(e) of the act and 21 CFR 860.130,

based on new information with respect to the device, FDA, on its own

initiative, is proposing to reclassify this device from class III to

class II when intended to provide penile rigidity in men diagnosed as

having erectile dysfunction.

Consistent with the act and the regulation, FDA did not refer,

because of the reasons stated herein, the proposed reclassification to

the Panel for its recommendation on the requested change in

classification.

III. Device Description

A penile rigidity implant is a device that consists of a pair of

semi-rigid rods implanted in the corpora cavernosa of the penis to

provide rigidity. It is intended to be used in men diagnosed as having

erectile dysfunction.

The proposed rule to reclassify the penile rigidity implant applies

to legally marketed penile rigidity implants identified above that were

commercially distributed before May 28, 1976, and to devices introduced

into commercial distribution since that date that have been found to be

substantially equivalent to such penile rigidity implants.

IV. Proposed Reclassification

FDA is proposing that the penile rigidity implant be reclassified

from class III to class II. FDA believes that class II with special

controls (specifically, the physician and patient labeling,

biocompatibility testing, mechanical reliability performance testing,

clinical testing, and sterilization requirements described in FDA's

guidance document entitled ``Guidance for the Content of Premarket

Notifications for Penile Rigidity Implants'') would provide a

reasonable assurance of safety and effectiveness.

V. Risks to Health

After considering the information discussed by the Panels during

the classification proceedings, as well as the published literature,

Medical Device Reports, and 515(i) submissions of safety and

effectiveness information, FDA has evaluated the risks associated with

the penile rigidity implant. FDA now believes that the following are

risks associated with the use of the penile rigidity implant:

A. Infection

Infection is a risk common to all surgical procedures and implants.

For penile rigidity implants, infection is typically reported to occur

in 1 to 8 percent of cases (average of 3 percent) (Refs. 3, 5, 7, 9,

13, 23, and 26). In most cases, these infections result from seeding at

the time of surgery and are reported as early post-operative

complications (Refs. 5 and 23). However, late occurring prosthetic

infections have been noted, and they are believed to be hematogenous in

nature as the result of dental or other surgical procedures (Refs. 5,

6, 13, 17, and 23).

The best defense against infections is prophylaxis, particularly

the selection of patients who are free of infection, the administration

of an intraoperative shave and scrub, the use of perioperative

antibiotics, and adherence to strict surgical technique (Refs. 5, 6,

18, 23, 26, and 32). However, even with these preventive measures,

certain patients, such as those with a history of urinary tract

infection, are still at risk for penile prosthesis infection (Refs. 5,

23, and 32).

The treatment of an infected penile prosthesis is removal of the

device combined with appropriate antibiotic medications (Refs. 21, 23,

and 26). A new device can either be placed at the time of removal, or 3

to 12 months later (Refs. 5, 7, 23, and 26). Sequela to penile

prosthesis infections include scarring/fibrosis at the site of the

prior implant, which could make reimplantation of a penile rigidity

implant difficult (Refs. 21 and 30). Serious sequela are rare (Ref.

11).

B. Erosion, Migration, and Extrusion

Erosion refers to the breakdown of tissue adjacent to the device.

Migration refers to the movement of the implant within the body. In

some cases, erosion may result in the external migration of the device,

which is called extrusion. Erosion, migration, and extrusion of a

penile rigidity implant are uncommon (<3 percent) complications (Ref.

28). Erosion and/or extrusion usually occur distally through either the

urethra or the glans penis (Ref. 26). Proximal migration of the device

without erosion or extrusion can result in inadequate support of the

glans penis (often called ``floppy glans'' or ``SST deformity'') (Refs.

28 and 31).

Factors contributing to erosion, migration, or extrusion include

implantation of a device that is too large, iatrogenic injury to the

surrounding tissues (i.e., urethra, corpora, etc.), and infection

(Refs. 26, 27, and 28). Additionally, it is possible that malfunction

of the implant could lead to erosion, migration, or extrusion if rough

or sharp edges are created or front/rear tips extenders become

detached. Other risk factors include previous pelvic surgery, pelvic

radiation, and spinal cord injury (Refs. 28 and 35).

Treatment of an eroded, migrated, or extruded device consists of

removal of the device, antibiotic treatment, and supportive care (Refs.

21, 26, and 28). If the condition is not treated in a timely manner,

the condition may worsen, leading to infection and loss of tissue (Ref.

21).

C. Mechanical Malfunction

As with other prosthetic devices intended to restore a physiologic

function, penile rigidity implants may malfunction mechanically. Rates

for mechanical malfunction vary with the type and model of penile

rigidity implant, and are believed to be significantly lower now than

they were with previous models due to improvements in design (Refs. 14,

17, and 27). Mechanical malfunction may be caused by improper device

handling or surgical technique, or problems with the device's design or

manufacturing process (Ref. 27).

Mechanical malfunctions may affect device effectiveness in terms of

decreases in device positionability, implant rigidity or column

strength, or length of the prosthesis (Refs. 1, 14, 19, 24, 25, and

36). Surgical intervention to remove and replace the device is required

if the patient desires a working prosthesis (Refs. 1, 33, and 36).

D. Patient Dissatisfaction

If patients are not provided information and counseled about the

risks and benefits of the penile rigidity implant prior to

implantation, they may not have realistic expectations of the physical,

psychological, and functional outcomes of the implant (Refs. 15, 26,

and 30). Uninformed patients may be dissatisfied with the outcome in

terms of size, shape, and rigidity of the prosthetic erection;

concealability of the penis; penile scarring; penile sensation; the

chance that any latent erectile capability will be lost following

surgery; or other performance characteristics (Refs. 17, 21, 26, and

34). Some dissatisfied patients have requested removal of a device that

was functioning according to the manufacturer's specifications because

the implant did not meet their expectations (Refs. 9 and 22). With

proper counseling, however, patient satisfaction with penile rigidity

implants is typically in the range of 85

[[Page 65773]]

to 91 percent (Refs. 8, 12, 14, 16, 17, and 37).

E. Adverse Tissue Reaction

If the materials used in the construction of the device are not

biocompatible, the patient may have an adverse tissue reaction. This

risk is not unique to penile rigidity implants, as patients may have an

adverse tissue or sensitivity reaction to any implanted device. Since

the time that the penile rigidity implant was originally classified,

few reports of adverse tissue reaction have been reported (Ref. 19).

Surgical removal of the implant is generally indicated in patients

experiencing prolonged discomfort or pain due to biocompatibility

issues associated with device materials.

F. Prolonged or Intractable Pain

As would be expected for any implant, surgical placement of a

penile rigidity implant results in temporary pain at the operative

sites during the recovery period. Infrequently, however, cases of

prolonged or intractable post-operative pain associated with device

implantation have also been reported (Ref. 22). Persistent or worsening

pain beyond the 4 to 6-week-post-operative healing period is

symptomatic of possible infection (Refs. 23 and 29). However, studies

have noted cases with persistent pain and subsequent device removal for

which culture results were negative (Ref. 14). It is possible that pain

can also be symptomatic of adverse tissue reaction, mechanical

malfunction, or incorrect sizing of the device. Prolonged or

intractable pain may lead to surgical intervention with device removal.

G. Urinary Obstruction

If the prosthesis compresses the urethra, urine flow could be

impeded (Ref. 8). However, since the time that the penile rigidity

implant was originally classified, reports of urinary obstruction

secondary to implantation of a penile rigidity implant have been rare

(Ref. 19). This complication may occur if the implant is improperly

sized or malpositioned by the implanting physician. Surgical

intervention may be indicated in patients experiencing urinary

obstruction associated with the presence of the device.

H. Silicone Particle Migration

The patient-contacting surfaces of penile rigidity implants consist

primarily of silicone elastomers. Neither silicone gel nor liquid are

used in the construction of these devices. The migration of silicone

particles from the solid elastomer exterior of various penile

prostheses has been described by Barrett et al. (Ref. 2). Although

particles of silicone were found in the tissues adjacent to the device

and in draining lymph nodes in some patients, no deleterious effects

have been associated with this finding to date. In a related study by

Fishman et al., patients with pre-existing penile implants underwent

pelvic lymph node dissection for reasons unrelated to the implant (Ref.

10). Microscopic examination of the lymph nodes showed no evidence of

silicone elastomer migration.

Since the time that the reasons for placing penile rigidity

implants into class III were first summarized, no adverse reactions

related to silicone particle migration have been documented. Therefore,

it appears that this theoretical risk may not be an actual risk of

penile rigidity implants.

I. Other Complications

Other infrequently reported complications of the penile rigidity

implant include post-operative bleeding, hematoma, penile edema, and

penile necrosis/gangrene (Refs. 3, 19, 20, 26, and 36). Intraoperative

complications have also been noted, which include perforation of the

corpora or the urethra, inability to adequately dilate the corpora,

incorrect sizing of the implant, and tearing or ripping the device

during implantation (Refs. 5, 19, 26, 30, and 36). All of these

complications can be reduced by good patient selection and careful

surgical technique.

VI. Summary of Reasons for Reclassification

FDA believes the penile rigidity implant should be classified into

class II because special controls, in addition to general controls,

provide reasonable assurance of the safety and effectiveness of the

device, and there is sufficient information to establish special

controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification is Based

In addition to the potential risks of the penile rigidity implant

described in section V of this document, there is reasonable knowledge

of the benefits of the device. Specifically, placement of the penile

rigidity implant in men with erectile dysfunction typically provides

sufficient penile rigidity for vaginal intercourse. Furthermore,

satisfaction rates in excess of 90 percent have been reported among

penile rigidity implant recipients (Refs. 8, 12, 14, 16, 17, and 37).

Based on the available information, FDA believes that the special

controls discussed in section VIII of this document are capable of

providing reasonable assurance of the safety and effectiveness of the

penile rigidity implant with regard to the identified risks to health

of this device.

VIII. Special Controls

In addition to general controls, FDA believes that the guidance

document entitled, ``Guidance for the Content of Premarket

Notifications for Penile Rigidity Implants'' (Ref. 38) is an adequate

special control to address the risks to health described in section V

of this document.

This guidance document addresses the following: (1) Physician

labeling, (2) patient labeling, (3) biocompatibility testing, (4)

mechanical testing, (5) clinical data requirements, and (6)

sterilization procedures and labeling.

A. Physician labeling

The physician labeling section of the guidance document can help

control the risks of infection, erosion, migration, extrusion,

mechanical malfunction, patient dissatisfaction, prolonged or

intractable pain, urinary obstruction, silicone particle migration, and

other miscellaneous clinical complications by having the manufacturer

provide information on: (1) The proper handling of the device prior to

implantation, (2) selection and preparation of the patient, (3)

surgical and sterile technique, (4) implant sizing, (5) care of the

implant site during and after the recovery period, (6) post-operative

use of the device, (7) how to recognize and minimize these potential

complications, (8) the normal healing process, and (9) the realistic

outcomes of the penile rigidity implant.

B. Patient labeling

The patient labeling section of the guidance document can help

control the risks of infection, erosion, migration, extrusion,

mechanical malfunction, patient dissatisfaction, prolonged or

intractable pain, urinary obstruction, silicone particle migration, and

other miscellaneous clinical complications by having the manufacturer

provide prospective patients information on: (1) Care of the implant

site during and after the recovery period, (2) post-operative use of

the device, (3) how to recognize and minimize these potential

complications, (4) the normal healing process, and (5) the realistic

outcomes of the penile rigidity implant.

C. Biocompatibility testing

Adherence to the biocompatibility testing section of the guidance

document can control the risk of

[[Page 65774]]

adverse tissue reaction by having the manufacturer demonstrate that the

patient contacting materials of the penile rigidity implant are safe

for long-term implantation.

D. Mechanical testing

Adherence to the mechanical testing section of the guidance

document can help control the risks of erosion, migration, extrusion,

and mechanical malfunction by demonstrating the reliability of the

device.

E. Clinical data requirements

For penile rigidity implants that are significantly different from

devices already on the market, the clinical data requirements section

of the guidance document can help control the risks of infection,

erosion, migration, extrusion, mechanical malfunction, and prolonged or

intractable pain by determining whether these risks are within the

limits established by existing devices.

F. Sterilization procedures and labeling

Adherence to the sterilization procedures and labeling section of

the guidance document can help control the risk of infection by

guarding against the implantation of an unsterile device.

IX. References

The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 am. and 4 pm., Monday through Friday.

1. Agatstein, E. H., J. H. Farrer, and S. Raz, ``Fracture of

Semirigid Penile Prosthesis: A Rare Complication,'' The Journal of

Urology, 135:376-377, 1986.

2. Barrett, D. M., D. C. O'Sullivan, A. A. Malizia, H. M.

Reiman, and P. C. Abell-Aleff, ``Particle Shedding and Migration

from Silicone Genitourinary Prosthetic Devices,'' The Journal of

Urology, 146:319-322, 1991.

3. Benjany, D. E., P. E. Perito, M. Lustgarten, and R. K. Rhamy,

``Gangrene of the Penis after Implantation of Penile Prosthesis:

Case Reports, Treatment Recommendations and Review of the

Literature,'' The Journal of Urology, 150:190-192, 1993.

4. Blue book memorandum #G95-1, ``Use of International Standard

ISO-10993, `Biological Evaluation of Medical Devices Part 1:

Evaluation and Testing,''' FDA.

5. Blum, M. D., ``Infections of Genitourinary Prostheses,''

Infectious Disease Clinics of North America, 3(2):259-274, 1989.

6. Carson, C. C., ``Infections in Genitourinary Prostheses,''

Urologic Clinics of North America, 16(1):139-147, 1989.

7. Choi, H. K., I. R. Cho, and Z. C. Xin, ``Ten Years of

Experience with Various Penile Prosthesis in Korean,'' Ynsei Medical

Journal, 35(2):209-217, 1994.

8. Dorflinger, T., and R. Bruskewitz, ``AMS Malleable Penile

Prosthesis,'' Urology, 28(6):480-485, 1986.

9. Earle, C. M., G. R. Watters, A. G. S. Tulloch, Z. S.

Wisniewski, D. J. Lord, and E. J. Keogh, ``Complications Associated

with Penile Implants Used to Treat Impotence,'' Australian and New

Zealand Journal of Surgery, 59:959-962, 1989.

10. Fishman, I. J., and F. N. Flores, ``Retrospective Review of

Pelvic Lymph Nodes in Patients with Previously Implanted Silicone

Penile Prosthesis,'' The Journal of Urology, 149:355A, 1993.

11. Goldman, J. M., and M. F. Wheeler, ``Primary Renal

Candidiasis Associated with a Penile Prosthesis in a Diabetic Man,''

The Journal of Diabetic Complications, 3:179-180, 1989.

12. Hrebrinko, R, R. R. Bahnson, F. N. Schwentker, and W. F.

O'Donnell, ``Early Experience with the Duraphase Penile

Prosthesis,'' The Journal of Urology, 143:60-61, 1990.

13. Kabalin, J. N., and R. Kessler, ``Infectious Complications

of Penile Prosthesis Surgery,'' The Journal of Urology, 139:953-955,

1988.

14. Kearse, W. S., Jr., A. L. Sago, S. J. Peretsman, J. O.

Bolton, R. G. Holcomb, P. K. Reddy, P. H. Bernhard, S. M. Eppel, J.

H. Lewis, M. Gladshteyn, and A. A. Melman, ``Report of a Multicenter

Clinical Evaluation of the Dura-II Penile Prosthesis,'' The Journal

of Urology, 155:1-4, 1996.

15. Kramarsky--Binkhorst, S., ``Female Partner Perception of

Small--Carrion Implant,'' Urology, 12(5):545-548, 1978.

16. Krauss, D. J., L. J. Lantinga, M. P. Carey, A. W. Meisler,

and C. M. Kelly, ``Use of the Malleable Penile Prosthesis in the

Treatment of Erectile Dysfunction,'' 142:988-991, 1989.

17. Lewis, R. W., ``Long-Term Results of Penile Prosthetic

Implants,'' Urologic Clinics of North America, 22(4):847-856, 1995.

18. Lynch, M. J., G. M. Scott, J. A. Inglis, and J. P. Pryor,

``Reducing the Loss of Implants Following Penile Prosthetic

Surgery,'' British Journal of Urology, 73:423-427, 1994.

19. Medical Device Reporting (MDR) and Product Problem Reporting

(PPR), Device Experience Network (DEN), FDA.

20. Melman, A., ``Experience with Implantation of the Small--

Carrion Penile Implant for Organic Impotence,'' The Journal of

Urology, 116:49-50, 1976.

21. Montague, D. K., ``Penile Prostheses. An Overview.,''

Urologic Clinics of North America, 16(1):7-12, 1989.

22. Moul, J. W., and D. G. McLeod, ``Experience with the AMS 600

Malleable Penile Prosthesis,'' The Journal of Urology, 135:929-931,

1986.

23. Mulcahy, J. J., M. D. Brant, and J. K. Ludlow, ``Management

of Infected Penile Implants,'' Techniques in Urology, 1(3):115-119,

1995.

24. Mulcahy, J. J., R. J. Krane, L. K. Lloyd, M. Edson, and M.

B. Siroky, ``Duraphase Penile Prosthesis--Results of Clinical Trials

in 63 Patients,'' The Journal of Urology, 143:518-519, 1990.

25. Mulcahy, J. J., ``Mechanical Penile Prostheses,'' Problems

in Urology, 7(3):311-316, 1993.

26. Mulcahy, J. J., ``The Management of Complications of Penile

Implants,'' Problems in Urology, 5(4)608-627, 1991.

27. Nielsen, K. T., and R. C. Bruskewitz, ``Semirigid and

Malleable Rod Penile Prostheses,'' Urologic Clinics of North

America, 16(1):13-23, 1989.

28. Oesterling, J. E., ``A Simple Technique for Removal of

Eroded Penile Prostheses,'' The Journal of Urology, 142:1538-1539,

1989.

29. Parsons, C. L., P. C. Stein, M. K. Dobke, C. P. Virden, and

D. H. Frank, ``Diagnosis and Therapy of Subclinically Infected

Prostheses,'' Surgery, Gynecology & Obstetrics, 177:504-506, 1993.

30. Petrou, S. P., and D. M. Barrett, ``The Use of Penile

Prostheses in Erectile Dysfunction,'' Seminars in Urology, 8(2):138-

152, 1990.

31. Quinn, A. D., and S. Das, ``Proximal Extrusion of Semirigid

Penile Prosthesis,'' Scandinavian Journal of Urology and Nephrology,

23:239-240, 1989.

32. Radomski, S. B., and S. Herschorn, ``Risk Factors Associated

with Penile Prosthesis Infection,'' The Journal of Urology, 147:383-

385, 1992.

33. Reisner, G. S., ``Experience with Penile Prostheses in 107

Patients,'' British Journal of Urology (Abstract), 65:87, 1990.

34. Steege, J. F., A. L. Stout, and C. C. Carson, ``Patient

Satisfaction in Scott and Small--Carrion Penile Implant Recipients:

A Study of 52 Patients,'' Archives of Sexual Behavior, 15(5):393-

399, 1986.

35. Steidle, C. P., and J. J. Mulcahy, ``Erosion of Penile

Prostheses: A Complication of Urethral Catheterization,'' The

Journal of Urology, 142:736-739, 1989.

36. Tawil, E. A., and J. G. Gregory, ``Failure of the Jonas

Prosthesis,'' The Journal of Urology, 135:702-703, 1985.

37. Thompson, I. M., F. R. Rodriguez, and E. J. Zeidman,

``Experience with Duraphase Penile Prosthesis: Its Use as

Replacement Device,'' Urology, 36(6):505-507, 1990.

38. ``Guidance on the Content of Premarket Notifications for

Penile Rigidity Implants,'' revised December 9, 1996, FDA.

39. Health Industry Manufacturers Association, 515(i) Submission

of Safety and Effectiveness, Docket No. 94N-0417, August 14, 1996.

40. Mentor Corp., 515(i) Submission of Safety and Effectiveness,

Docket No. 94N-0417, August 14, 1996.

X. Environmental Impact

The agency has determined under 21 CFR 25.24(e)(2) that this

proposed classification 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 the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as

amended by subtitle D of the Small Business

[[Page 65775]]

Regulatory Fairness Act of 1996 (Pub. L. 104-121), and the Unfunded

Mandates Reform Act of 1995 (Pub. L. 104-4). 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 rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the proposed

rule 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. Reclassification of this device from class III to

class II will relieve all manufacturers of the device of the cost of

complying with the premarket approval requirements in section 515 of

the act. Because reclassification will reduce regulatory costs with

respect to this device, it will impose no significant economic impact

on any small entities, and it may permit small potential competitors to

enter the marketplace by lowering their costs. The agency therefore

certifies that the final rule will not have a significant economic

impact on a substantial number of small entities. The rule also does

not trigger the requirement for a written statement under section

202(a) of the Unfunded Mandates Reform Act because it does not impose a

mandate that results in an expenditure of $100 million or more by

State, local, or tribal governments in the aggregate, or by the private

sector, in any 1 year.

XII. Comments

Interested persons may, on or before March 16, 1998 submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. 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.

List of Subjects in 21 CFR Part 876

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 876 be amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

1. The authority citation for 21 CFR part 876 continues to read as

follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2. Section 876.3630 is revised to read as follows:

Sec. 876.3630 Penile rigidity implant.

(a) Identification. A penile rigidity implant is a device that

consists of a pair of semi-rigid rods implanted in the corpora

cavernosa of the penis to provide rigidity. It is intended to be used

in men diagnosed as having erectile dysfunction. (b) Classification.

Class II (special controls) (premarket notification guidance).

Dated: November 11, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 97-32809 Filed 12-15-97; 8:45 am]

BILLING CODE 4160-01-F