[Federal Register Volume 59, Number 85 (Wednesday, May 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10785]


[[Page Unknown]]

[Federal Register: May 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 878

[Docket No. 91N-0281]

 

General and Plastic Surgery Devices; Effective Date of 
Requirement for Premarket Approval of Silicone Inflatable (Saline-
Filled) Breast Prosthesis; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing on a proposed rule to amend its regulations to require the 
filing of a premarket approval application (PMA) or a notice of 
completion of a product development protocol (PDP) for the silicone 
inflatable (saline-filled) breast prosthesis, a medical device. The 
purpose of the public hearing is to assist the agency in determining 
when to issue a final rule to require the filing of a PMA for the 
silicone inflatable breast prosthesis.

DATES: The public hearing will be held on Thursday, June 2, 1994, from 
9 a.m. to 6 p.m. Submit written notices of participation and comments 
by May 16, 1994. Written comments will be accepted until July 5, 1994.

ADDRESSES: The public hearing will be held at the Sheraton Washington 
Hotel, 2660 Woodley Rd. NW., Washington, DC 20008. Submit written 
notices of participation and comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. Written notices of participation can also be faxed 
to 301-594-0113. A limited number of hotel rooms have been reserved at 
the Sheraton Washington Hotel for June 1, 1994. Attendees are 
responsible for making their own reservations. In order to receive the 
established rate, attendees should refer to the FDA hearing. 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.

FOR FURTHER INFORMATION CONTACT: Thomas Arrowsmith-Lowe, Office of 
Health Affairs (HFY-40), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-443-1472.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 515(b)(1) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360e(b)(1)) establishes the requirement that a 
preamendments device that FDA has classified into class III is subject 
to premarket approval. Section 515(b)(2)(A) of the act provides that a 
proceeding for the promulgation of a final rule to require premarket 
approval shall be initiated by publication of a notice of proposed 
rulemaking in the Federal Register.
    If the proposed rule to require premarket approval for a 
preamendments device is made final, section 501(f)(2)(B) of the act (21 
U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a 
PDP for any such device be filed within 90 days of the date of 
promulgation of the final rule or 30 months after final classification 
of the device under section 513 of the act (21 U.S.C. 360c), whichever 
is later. If a PMA or notice of completion of a PDP is not filed by the 
later of the two dates, commercial distribution of the device is 
required to cease. The device may, however, be distributed for 
investigational use if the manufacturer, importer, or other sponsor of 
the device complies with the investigational device exemption (IDE) 
regulations. The act does not permit an extension of the 90-day period 
after promulgation of a final rule within which an application or a 
notice is required to be filed.

II. Summary of Risks and Benefits

    In the Federal Register of January 8, 1993 (58 FR 3436), FDA 
published a proposed rule to require the filing, under section 515(b) 
of the act (21 U.S.C. 360e(b)), of PMA's for the classified silicone 
inflatable (saline-filled) breast prosthesis and all substantially 
equivalent devices. In accordance with section 515(b)(2)(A) of the act, 
FDA included in the preamble to the proposal the agency's proposed 
findings regarding: (1) The degree of risk of illness or injury 
designed to be eliminated or reduced by requiring the device to meet 
the premarket approval requirement of the act, and (2) the benefits to 
the public from use of the device (58 FR 3436 at 3438). The following 
is a summary of those findings.
    The envelope or shell of the silicone inflatable breast prosthesis 
is made of silicone rubber. Accordingly, prolonged contact with the 
prosthesis raises the same questions about the potential risks for 
adverse immunological effects and/or connective tissue disorders that 
have been asked with regard to the use of silicone gel-filled breast 
prostheses and silicone injections. In addition, no satisfactory, 
independent data base has been compiled to serve as a basis for the 
thorough evaluation of the chronic toxic effects and the possible 
teratogenic effects of silicone. Lastly, neither particles which may 
shed from the silicone shell, nor the chemical forms of silicone 
monomers or other additives which may leach from the shell, have yet 
been adequately characterized with regard to metabolism, distribution, 
and excretion.
    The most common risk associated with breast augmentation and 
reconstruction is fibrous capsular contracture, the formation of a 
constricting fibrous layer around the prosthesis. Capsular contracture 
may result in excessive breast firmness, discomfort, pain, 
disfigurement, and/or displacement of the implant. Deflation of the 
implant is another risk associated with use of the device. Deflation, 
which results from partial or total loss of the contents due to 
puncture, rupture, or other failure of the shell, or a faulty valve, 
results in the loss of shape of the prosthesis, and often requires 
surgical intervention to correct. Lastly, the presence of any breast 
prosthesis may interfere with standard mammography procedures used to 
screen patients for breast cancer. By compressing overlying breast 
tissue, the presence of the implant makes it more difficult to detect 
small tumors. In addition, the presence of the implant can produce a 
shadow on the radiograph that may reduce visual clarity of a 
significant portion of the breast.
    Whether performed for reconstruction or augmentation purposes, 
breast prosthesis implantation is a discretionary, elective surgical 
procedure performed for its psychological benefits. Several studies 
have been published that show psychological improvement in both 
reconstruction and augmentation patients; however, these studies did 
not use objective, standardized methodologies that have been validated 
for measuring the psychological benefit of the device.
    The silicone inflatable (saline-filled) breast prosthesis is 
currently the only device legally available for breast augmentation. 
For breast reconstruction, the current legal restrictions on the use of 
silicone gel-filled implants limit their use to those cases where the 
silicone inflatable (saline-filled) breast prosthesis is considered 
medically unsatisfactory.

III. Public Hearing

    Based on the available scientific evidence and comments received on 
the proposed rule, FDA has concluded that PMA's will need to be 
submitted and evaluated for the silicone inflatable (saline-filled) 
breast prosthesis. However, the agency has also determined that a 
public hearing is warranted to assist the agency in determining when to 
issue a final rule to require the filing of PMA's for the silicone 
inflatable breast prosthesis.
    The agenda for the hearing will include: (1) An overview by FDA of 
the statutory procedure for requesting the submission of PMA's for 
preamendment class III devices; (2) a presentation by FDA on the 
preclinical and clinical studies that are required to be completed to 
support a PMA for the silicone inflatable breast prosthesis; (3) oral 
testimony by the manufacturers on the status of their scientific 
studies, including their prospective clinical studies, and the 
scheduled timeframe for completion of those studies; and (4) oral 
testimony by consumers and/or representatives of consumer and health 
professional organizations to assist the agency in determining when to 
require the filing of PMA's for the silicone inflatable breast 
prosthesis. To the extent possible, oral testimony should address the 
following issues:

Manufacturers

    1. To what extent do protocols for your pre-clinical testing and 
ongoing clinical prospective studies reflect the elements identified in 
the guidance for submission of PMA's for the silicone inflatable breast 
prosthesis? For major items that do not comply with the FDA guidance 
document, what is the basis for the scientific validity of the involved 
tests and/or studies?
    2. When were such studies commenced, and when do you expect to have 
completed all the studies that are necessary for submission of a PMA?
    3. How many patients are being implanted with silicone inflatable 
(saline-filled) breast prostheses at the current time (e.g., 1993 
through the present)?

Consumers and Representatives of Consumer and Health Professional 
Organizations

    1. Based on the risks to health as you understand them today, what 
degree of priority do you recommend that FDA give to calling for safety 
and effectiveness data for the silicone inflatable breast prosthesis?
    2. Based on the benefits of the device as you understand them 
today, to what extent do you believe that continued availability of the 
silicone inflatable breast prosthesis fulfills an important patient 
need that would otherwise be unmet if the device was no longer 
commercially available or restricted in its availability?
    3. Do you believe that FDA should distinguish between use of the 
device for breast reconstruction versus use for augmentation purposes 
in its regulation of the silicone inflatable breast prosthesis?

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with 21 CFR part 15. The presiding 
officer will be Carol Scheman, Deputy Commissioner for External 
Affairs, Food and Drug Administration. Ms. Scheman will be joined by 
other FDA officals.
    Persons who wish to participate must file a written notice of 
participation with the Dockets Management Branch (address above) on or 
before May 16, 1994. All notices submitted should be identified with 
the docket number found in brackets in the heading of this document and 
should contain the person's name, address, telephone number, FAX 
number, business affiliation, if any, a brief summary of the 
presentation, and the approximate time requested for the presentation.
    The agency requests that individuals or groups having similar 
interests consolidate their comments and present them through a single 
representative. FDA may require joint presentations by persons with 
common interests. FDA will allocate the time available for the hearing 
among the persons who properly file a notice of participation.
    After reviewing the notices of participation and accompanying 
information, FDA will schedule each appearance and notify each 
participant by mail, telephone, or FAX, of the time allotted to the 
person and the approximate time the person's presentation is scheduled 
to begin. The schedule of the public hearing will be available at the 
hearing. After the hearing, it will be placed on file in the Dockets 
Management Branch (address above) under docket number 91N-0281.
    Under Sec. 15.30 the hearing is informal, and the rules of evidence 
do not apply. No participant may interrupt the presentation of another 
participant. Only the presiding officer and panel members may question 
any person during or at the conclusion of their presentation.
     Public hearings, including hearings under part 15, are subject to 
FDA's guideline (21 CFR part 10, Subpart C) concerning the policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings. Under Sec. 10.205, representatives of the electronic media 
may be permitted, subject to certain limitations, to videotape, film, 
or otherwise record FDA's public administrative proceedings, including 
presentations by participants. The hearing will be transcribed as 
stipulated in Sec. 15.30(b). Orders for copies of the transcript can be 
placed at the meeting or through the Dockets Management Branch (address 
above).
    Any handicapped persons requiring special accommodations in order 
to attend the hearing should direct those needs to the contact person 
listed above.
     To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in 
Sec. 15.30(h).
    The administrative record of the proposed rule will remain open 
until July 5, 1994, to allow comments on matters raised at the hearing. 
Persons who wish to provide additional materials for consideration 
should file these materials with the Dockets Management Branch (address 
above) by July 5, 1994.

    Dated: April 29, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-10785 Filed 5-2-94; 10:14 am]
BILLING CODE 4160-01-F