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8-K
UNITED STATES SURGICAL CORPORATION
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
The Securities Act of 1934
Date of Report (Date of earliest event reported): June 4, 1996
United States Surgical Corporation
(Exact name of registrant as specified in its charter)
Delaware 1-9776 13-2518270
(State or other jurisdiction (Commission File (I.R.S. Employer
of incorporation) Number) Identification Number)
150 Glover Avenue, Norwalk, CT 06856
(Address of principal executive offices)
(203) 845-1000
(Registrant's telephone number, including area code)
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Item 5. Other Events.
The Registrant is filing herewith the press release issued by the
Registrant on June 4, 1996 and correspondence received from the Food and Drug
Administration Center for Devices and Radiological Health.
Item 7. Financial Statements and Exhibits.
(c) Exhibits
Exhibit 99.1. Press Release dated June 4, 1996.
Exhibit 99.2. Letter from Food and Drug Administration Center for Devices and
Radiological Health.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
UNITED STATES SURGICAL CORPORATION
Date: June 4, 1996 By: /s/ Howard M. Rosenkrantz
Howard M. Rosenkrantz
Senior Vice President, Finance and
Chief Financial Officer
(Principal Financial Officer)
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE: June 4, 1996
FOR FURTHER INFORMATION: U.S. SURGICAL HOME PAGE:
Marianne Scipione http://www.ussurg.com
Vice President
Corporate Communications
(203) 845-1404
U.S. SURGICAL CORPORATION RESPONDS TO FDA INQUIRY
-------------------------------------------------
NORWALK, Conn--United States Surgical Corporation (NYSE:USS) announced
today that the company received on June 3, 1996 a warning letter from the FDA
regarding labeling claims and descriptive benefits of its ABBI* biopsy system.
In a recent telephone conversation, a senior FDA device reviewer
informed the company that he believes the FDA may have made an error with
respect to the predicate devices cited in the clearance of this 510-K, necessary
to market the Company's ABBI* system is questioning whether they were correct in
issuing a 510-K approval and may seek a rescission of such approval. However,
the reviewer informed the company's senior regulatory officer that the FDA is
not questioning the safety or efficacy of the company's ABBI* system or the
veracity of USSC's 510-K submission.
The company believes that the FDA's position is incorrect and intends
to resolve these issues with the agency.
The company will meet with the FDA to assure its staff that it was
correct in issuing its 510-K approval to market, that there are sufficient
predicate devices to satisfy the FDA in this decision, and will seek to provide
comfort to the FDA that the company's descriptive claims relative to the
product's function are factually correct and in the best interest of the
patient.
Discussions with the FDA will include surgeons with clinical experience
in the use of the ABBI* system who can attest to the appropriateness of this
system as a superior biopsy devise, the ABBI*'s significant clinical benefits to
women undergoing breast biopsy and to the significant reduction in cost that the
ABBI* system provides for breast biopsy.
The company cannot predict how long it will take to resolve these issues
or its impact.
United States Surgical Corporation is the world's largest manufacturer
and marketer of surgical staplers, the innovative leader in the expanding field
of minimally invasive surgery and a growing participant in the suture market.
###
*Trademark of United States Surgical Corporation
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EXHIBIT 99.2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
_______________________________________________________________________
Food and Drug Administration
Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850
WARNING LETTER
--------------
VIA FEDERAL EXPRESS
- -------------------
Mr. Leon C. Hirsch
Chairman
United States Surgical Corp.
150 Glover Avenue
Norwalk, Connecticut 06856
RE: ABBI Biopsy System
Dear Mr. Hirsch:
The Food and Drug Administration (FDA) has reviewed a press release issued by
United States Surgical Corp. (U.S. Surgical) on February 13, 1996, regarding
your company's ABBI system, which comprises products considered devices under
section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). The Agency
has also reviewed an article published in the New Haven Register on February 14,
1996, a wire service report published by Reuters on February 13, 1996, and a
press release issued by Carlisle Hospital on April 24, 1996. We have enclosed a
copy of each published piece.
Each of the first two reports describes the ABBI system as being "what the
company says is the world's first instrument for minimally invasive breast
surgery." The Reuters report refers to your "ABBI device for breast surgery."
The only piece that provides the entire name of the device is the Carlisle
Hospital press release, which refers to the Advanced Breast Biopsy
Instrumentation system. The FDA cleared two biopsy devices produced by your
company. One is the Auto Suture Biopsy Device, assigned 510(k) number K954628.
The other is the Auto Suture Stereotactic Biopsy Device, assigned 510(k) number
K954629. Because of the discussion in the various published pieces, we assume
that the ABBI system comprises your Auto Suture Stereotactic Biopsy Device and
the stereotactic imaging table manufactured by Lorad and used in conjunction
with your device.
The representations described above for the uses of the ABBI are not within the
use for which FDA cleared either of your company's biopsy devices for marketing.
The devices were cleared for marketing as gastroenterology-urology biopsy
instruments, the intended use for which is provided in 21 CFR 876.1075. That
section provides that a gastroenterology-urology biopsy instrument is a device
used to remove, by cutting or
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aspiration, a specimen of tissue for microscopic examination. This generic type
of device includes the biopsy punch, gastrointestinal mechanical biopsy
instrument, suction biopsy instrument, gastro-urology biopsy needle and needle
set, and nonelectric biopsy forceps. This section of the CFR does not apply to
biopsy instruments that have specialized uses in other medical specialty areas
and that are covered by classification regulations in other parts of the device
classification regulations.
The statement in the press release issued by your company, which is then
repeated in the other items, that the ABBI system eliminates the need for a
second procedure is a statement that a surgical procedure to remove any further
tissue is unnecessary and is at least an implied claim that the biopsy device is
itself a surgical tool that can be used to perform lumpectomies, and your
company has, as noted above, made an explicit claim that the device is for
"minimally invasive breast surgery." The press release issued by U.S. Surgical
states that "unlike core needle biopsies, where multiple tissue samples are
removed, the ABBI instrument is inserted only once to remove the entire
specimen. If the specimen proves to be cancerous, but pathology reports the
entire margin is clean, it is up to the clinical judgment of the surgeon as to
whether additional tissue must be removed or the procedure can be considered
complete. Finally, by replacing the two-step process with a single, minimally
invasive procedure, the ABBI system is easier for the patient and operating room
staff and can reduce costs." While you may make a claim regarding the efficiency
of your device for specimen removal for diagnostic purposes, which may involve
the ability of your product to remove specimens that have clean margins, the
implication that efficiency obviates and, according to your statement,
replaces further procedures is inappropriate because it turns the removal of
specimens for diagnosis into the therapeutic removal of cancerous tissue.
The press release issued by Carlisle Hospital referred to the "latest technique
for diagnosing breast cancer." The release says that the ABBI could someday
replace the procedure commonly referred to as a "lumpectomy." While FDA does not
regulate the promotional activities of the hospital, the hospital has been
chosen by you to participate in the use of the ABBI system and the Agency
believes that the hospital's language describing the system's intended use most
likely reflects the way U.S. Surgical has characterized its device. It is
inappropriate for Carlisle Hospital to describe your device as being potentially
able to perform procedures for which the device has not been cleared.
In a letter to the Agency dated October 17, 1995, Janet Johnson, U.S. Surgical's
Regulatory Affairs Associate, stated that the company wished to correct an error
made in the intended uses for one of your biopsy devices. The corrected language
was to read, "The Auto Suture Stereotactic Biopsy Device has indications for
transecting tissue during a surgical biopsy procedure." Because obtaining tissue
for a biopsy is generally considered a surgical
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procedure, the word "surgical" was added to the intended use at the company's
request. The reviewer with whom Ms. Johnson communicated, however, informed the
company that the clearance granted your company for the device would include
only intended use as a diagnostic tool, and that you could not make claims for
the device as a surgical instrument.
Describing the ABBI system for breast surgery has, therefore, misbranded your
Auto Suture Stereotactic Biopsy Device under Section 502(o) of the Act in that
appropriate premarket notification required by section 510(k) of the Act was not
submitted. The FDA's regulations at 21 CFR 801.4 provide that the term "intended
uses" refers to the objective intent of the persons legally responsible for the
labeling of devices. That intent may be shown by labeling claims or advertising
matter or oral or written statements by such persons or their representatives.
Including the device in a system with the name that includes the word "breast"
impermissibly changes the intended use of the device, which was cleared, as
described above, as a gastroenterology-urology biopsy device. Making a claim
regarding breast surgery constitutes another major change in the intended use of
the product. Pursuant to section 510(k) of the Act and as explained in 21 CFR
807.81(a)(3)(ii), such changes require the submission of premarket notification.
The ABBI system marketed with claims for breast surgery adulterates your Auto
Suture Stereotactic Biopsy Device within the meaning of section 501(f)(1)(k) of
the Act in that it is a class III device under section 513(f) of the Act, and
does not have an approved application for premarket approval in effect pursuant
to section 515(a) of the Act, or an approved application for an investigational
device exemption under section 520(g).
The materials other than the press release issued by U.S. Surgical that discuss
the product represent summaries of the same information presented in that press
release. The Agency assumes that these materials either derive from the press
release or are published based on information obtained directly from the
company.
This letter is not intended to be an all-inclusive list of deficiencies
associated with the ABBI system. It is your responsibility to ensure adherence
to each requirement of the Act and the Federal regulations. The specific
violations in this letter may represent practices used in other promotional or
advertising materials used by your firm. You are responsible for investigating
and reviewing these materials to ensure compliance with applicable regulations.
You should take prompt action to correct these violations. Failure to promptly
correct these deviations may result in regulatory action being initiated by FDA
without further notice. These actions include, but are not limited to, seizure,
injunction, and/or civil penalties.
Please notify this office within 15 working days of the receipt of this letter
of the specific steps you have taken to correct the cited violations. Your
response should also include all steps being taken to address false and
misleading information currently in the marketplace
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and actions to prevent similar violations in the future. If corrective action
cannot be completed within 15 working days, state the reason for the delay and
the time within which the corrections will be completed.
Send your response to Deborah Wolf, Regulatory Counsel, Promotion and
Advertising Policy Staff, Office of Compliance (HFZ-302), Center for Devices and
Radiological Health, 2098 Gaither Road, Rockville, Maryland 20850.
A copy of this letter is being sent to FDA's Boston District Office. Please send
a copy of your response to the District Director, Boston District Office (HFR-
NE240), One Montvale Avenue, Stoneham, Massachusetts 02180.
Sincerely yours,
Lillian J. Gill
Director
Office of Compliance
Center for Devices and
Radiological Health
Enclosures
