Toxic Protection / Confidence Shock /  Why Am I Sick?  /  Scenarios

 

 

 

Despite considerable attention being given to such matters, mistakes continue to be made...

 

 

-- Denti et al., “Tampon Outer Surface Having Increasing Number of Written Identifiers To Indicate Absorbancy,” United States Patent #US 7,166,100 B2, Filed Dec. 9, 2005; Date of Patent Jan. 23, 2007

 

 

 

 

 

 

 

 

 

 

 

 

Susan May Wilson, in her 2003 paper entitled “The Toxic Shock Crisis of 1980,” suggests a scenario in which the crisis might have been averted:

 

“A study conducted in 1979 [...] revealed that carboxymethyl cellulose, or CMC, worked as a filter for bacterial toxins.  A simple analysis of the ingredients in Rely’s new tampons would have revealed the presence of this fiber to the FDA.  Though...CMC was not the ingredient that caused TSS, had the FDA then required that more research be conducted on the Rely tampon before it entered the market, they might have identified a problem with Rely’s polyester foam, which may have spared many lives.”

 

Carboxymethyl cellulose – harmless enough, it turns out

 

 

 

 

 

 

 

 

 

Another scenario that “may have spared many lives” centers on the tampon design process itself. 

 

It was in 1973, a full seven years before the US toxic shock outbreak, that P&G filed a patent application for the Rely tampon, listing Jean Edward Schaefer of Cincinnati, Ohio, as the sole inventor.

 

The P&G patent states that Schaefer’s invention:

 

“...maintains a large void volume within the vagina and, therefore, has a greater capacity; it is large enough to fill out substantially the entire cross-section of the vagina and, therefore, provides containment; it has a large available surface area which has resulted in unexpectedly high absorption rates;...”

 

 

 

 

Rely tampon,  Drawings, US Patent

3,815,601, granted to P&G June 11, 1974

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[arrows inserted by MOLT]

 

 

The P&G patent further explains that:

 

“A high absorption rate is an important attribute of a tampon in order to prevent partitioning failure, which occurs when the rate of fluid flow to the tampon exceeds the absorption rate of the tampon...”

 

Perhaps if the reverse had been explored during the design process (that is, what happens when a tampon’s rate of absorption exceeds the rate of fluid flow), “many lives may have been spared.” 

 

From the FDA website, 2006:

 

Because the TSS risk increases with tampon absorbency, if you use tampons, you should use products with the lowest absorbency that meets your needs.  There’s usually less need for higher absorbency at the end of a menstrual period.”

 

From Rely 1980 product leaflet:

 

“Rely is so comfortable you could forget you’re wearing it [...] Change at least once a day even if you’re flowing lightly.”

 

From P&G’s US Patent 3,815,601:  Table showing jump in absorbency rates from “solid block” foam to Rely’s “aggregate” foam (that is, cut into pieces:  “...the pieces need not necessarily be uniformly shaped, in fact, they preferably are very irregularly shaped as such would result by chopping in a Waring kitchen blender.  Pieces were chopped for the tampon of this invention in a Waring kitchen blender by putting blocks of Hydro-Foam™ in the blender”).

 

 

 

 

 

 

 

 

 

Perhaps it’s unfair to point out in 2007 what was not obvious in 1973.

 

However, in 1977*, four years after the filing of the P&G patent, Kimberly-Clark, maker of Kotex tampons, addressed the issue of high absorbency/low fluid flow in one of their own patent applications:

 

“..., one noticeable shortcoming of the higher capacity tampon not experienced with the conventional tampon products was the fact that withdrawal of the used tampon appeared to be more difficult and have greater frictional drag than conventional tampons.  This was particularly noticeable when the superabsorbant tampon was removed early and/or when it contained relatively small amounts of absorbed fluid whereby only a portion of the tampon cavity was utilized.”

 

Is this the first description of the “toxic shock scenario” on public record?

 

* Interestingly, 1977 is the same year the Society for Menstrual Cycle Research was founded.

 

 

“Table 1. Coefficients of Static and Sliding Friction” from Mark’s Mechanical Engineers’ Handbook, 1951.  “Copper on glass” is listed,  “cast iron on oak” is listed, but “tampon on vaginal wall” is not.

 

 

 

 

 

 

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