CALL FOR ACTION - ENDOSCAPE

A LETTER URGING FDA TO TAKE A REGULATORY ACTION AGAINST CERTAIN MANUFACTURERS OF RECENTLY

INTRODUCED SURGICAL STAPLING SYSTEM PRODUCTS FOR* :

(1) making unsubstantiated claim(s) regarding clinical performance of the products

One of the marketing ploys widely employed by certain manufacturers to promote newly introduced surgical stapling

products incorporating a "novel" technological feature(s) is to highlight the improvements in functional and/or clinical

performance of the new product over currently marketed equivalent product. Typically, the manufacturers are quick

to erroneously/illogically attribute the beneficial performance of the new product to the "novel" technological

feature(s), be it modification and/or manipulation of engineering or operational parameter(s) of equivalent existing

product. Examples of the "novel" features include a slope or bumps on the staple cartridge deck, formed staples with

offset legs and variation of staple firing speed.

Virtually without exception, the "novel" technological feature(s) appear to be introduced arbitrarily without scientific

basis. No publicly available information can be found (not even in the earliest published patent records related to the

"novel" features) on the in-depth scientific analysis of its technological characteristics or its impact on the operational

characteristics of the new product that may shed light on scientific rationale for introducing the "novel" features

into the design of a new stapling product. This fact alone makes assertion on the part of the manufacturers of the

functional and/or clinical performance claims erroneous/illogical and the claims, particularly, clinical performance

claims themselves scientifically unsubstantiated. It is a plain truth that it is logically impossible to establish a

scientific causality between an action, having no scientific basis, in the form of technological manipulation in this

case and an effect, entirely removed from the action, in the form of clinical outcome. The logical relationship between

the "novel" features and the claimed functional and/or clinical performance can only be incidental and random. In

short, the manufacturers are in error and potentially misleading in their futile attempt to tie the "novel" technological

features with the claimed improvement in the functional and/or clinical performance of the new products.

The manufacturers also cites one or more "internal studies", not readily accessible or inaccessible to the public, as

justification for the functional and/or clinical performance claims for the new products. These "internal studies" are

typically very limited in scope and ripe for manipulation to serve the purpose of marketing the new products.

Although one cannot state conclusively having no access to the texts describing these "internal studies" it would not

be unreasonable to state that the results of the studies can hardly be scientifically regarded a basis for the the

functional and/or clinical performance claims by the manufacturers given the boastful and overly broad manner with

which the claims are often expressed without concurrently disclosing in proactive manner the limiting factors of the

"internal studies".

(2) failing to adequately disclose the risks associated with the products

There exists little information provided by certain manufacturers of new stapling products incorporating "novel"

technological features with regard to the risks associated with use of the new products. It would be prudent and in

fact mandatory on the part of the manufacturers of the new stapling products to conduct a thorough analysis of risks

associated with use of the new stapling products and openly disclose the results together with particular benefits

attributable to the "novel" technological features. It is not clear whether the manufacturers have not carried

out the required risk analysis or have carried the risk analysis but decided to withhold the findings of analysis.

(3) withholding key scientific evidence(s) in support of the claimed clinical performances of the products that could

potentially help uncover hidden/undisclosed risks associated with the products

The scientific basis of autonomous control algorithms, including autonomous determination of staple firing speed and

degree of tissue compression for automated stapling instrument products must be disclosed along with analysis of

risks associated with the use of autonomous algorithms.

A LETTER URGING FDA TO TAKE A REGULATORY ACTION AGAINST CERTAIN MANUFACTURERS OF CURRENTLY

MARKETED SURGICAL STAPLING PRODUCTS* :

(1) to withdraw and prohibit making functional or clinical performance claims for the products solely based on

"internal bench top or preclinical or pilot studies"

These "internal studies" appear to be designed not necessarily in accordance with the known scientific research

methodology and may be in most cases heavily biased/engineered to produce a preset conclusion(s) preconceived only

to advantageously serve the purpose of marketing the products.

Certain manufacturers of surgical stapling products has been and are exploiting these exploratory studies, of little or

no scientific merit and mostly hidden to avoid public and scientific scrutiny, in a futile attempt to tie new

technological features, arbitrarily introduced without scientific basis, e.g., a slope or bumps on the staple cartridge

deck, or formed staples with offset legs, with desired/imagined advancements in the art of surgical stapling by making

potentially misleading or false claims with regard to the functional and even clinical performance of the new

products.

Of particular concern is the fact that certain manufacturers tend to blatantly misrepresent the functional or clinical

performance claims based on the findings of these exploratory studies conducted on a specific organ tissue, e.g., the

stomach, as being universally valid regardless of the type of organ tissue.

These scientifically ill-disciplined practices on the part of certain manufacturers do more harm than good to the

art of surgical stapling that is critically in need of disruptive advancements to address the chronic problems as

identified by the FDA in the final reclassification order in October 2021.

It would be appropriate and necessary to strengthen the FDA's oversight on the labeling for surgical stapling products,

as presented in the website for the products in step with the reclassification of the surgical staplers for internal use to

round out the measures for improving safety and effectiveness profile of the surgical stapling products.

(2) to encourage the manufacturers to rigorously adhere to the known scientific practices in designing and performing

empirical studies in support of the functional or clinical performance claims of the products and to seek publication

of the results of the studies in reputable, peer-reviewed journal(s) to bolster scientific credibility, if possible, or

otherwise make them publicly available

One would see it as a matter of principle for the FDA, in administering its regulatory authority, to employ a reasonably

high degree of scientific rigor consistently across most, if not all, of the products under its purview. It would be

unimaginable the FDA would permit, for example, the manufacturers of pharmaceutical products and, presumably,

most medical devices other than the surgical stapling products to make substantive marketing claims for their

approved products based on post-market explorative studies alone which, incidentally, are typically published. There

is no obvious reason why the surgical stapling products may be an exception, especially, when the studies supporting

the claims are on potentially dubious scientific ground.

A LETTER ENCOURAGING EACH PERTINENT ACADEMIC ORGANIZATION TO URGE THE MANUFACTURERS OF

CURRENTLY MARKETED SURGICAL STAPLING PRODUCTS TO* :

(1) promptly acknowledge the problems associated with the currently marketed surgical stapling products as

identified by the FDA in the final reclassification order in October 2021

(2) urgently initiate efforts to update and modernize their surgical stapling products currently in the market or under

development with focus on addressing the identified problems

(3) rigorously adhere to, and proactively and clearly disclose the scientific principles or bases pertaining to the

current and future surgical stapling technologies in development and marketing of their surgical stapling products

(4) diversify the stapling products to accommodate distinctiveness in the anatomical and physiological characteristics

of organs subject to stapling operation