Just Some Random Thoughts.

Nov 01, 2011 21:29



I like to read things when I am doing mundane life maintenance and hygiene tasks, as it quenches my constant desire for information and stimulation. While humdrummingly brushing my teeth in the bathroom one evening, I chanced upon the conveniently-located-at-eye-level side panel of my box of Tampax tampons in the bathroom cabinet. If you are female, you are probably familiar with the terms lite, regular, super, super plus, and ultra because, as I found out from the side panel, these are standardized, industry-wide absorbency terms that indicate the number of grams of liquid that each vaginal cotton bullet will hold.

I then wondered, “Why would all the tampon brands gather together and standardize an absorbency? Wouldn’t that require costly collaboration and reduce their ability to sway consumer beliefs about a particular brand’s effectiveness?”

I discovered that the Food and Drug Administration regulates tampons and defined the actual absorbency ranges for various sizes, and the terms used for each. For what reason would the FDA be involved in regulating such an item and how could the tampon legally fall under their purview? I considered the idea that standardization might be some sort of honesty-in-advertising issue, but the government regulation of the tampon has a much more complex history. A Google search lead me to a fantastic research piece that contained everything I have or will ever want to know about the regulation of tampons in the U.S.

So, for your reading pleasure and enjoyment, I have taken a moment to highlight the key findings of my tampon interest research:
Tampons didn’t exist in the U.S. until O.B. and Procter and Gamble started test-marketing them in 1974. They had been in Europe since the 30′s.
Tampons are classified as a Class II Medical Device and regulated as such by the FDA. Other Class II devices include x-ray machinery, surgical needles, suturing materials and acupuncture needles. (lol - Class II, huh? I find this to be a ridiculous and overzealous definition for a glorified cotton ball that just happens to have a more noble cause than removing my nail polish.)
Anyway, TSS (Toxic Shock Syndrome), is the reason the FDA even got involved in the tampon industry, starting in 1980. I will not go on to discuss TSS in detail because I’m not interested and have always assumed it to be one of those rare and pretend problems, but, in short, it is a syndrome caused by bacteria entering the vaginal canal as a result of tampon insertion, causing horrendous bodily rejection of toxic bacteria and can result in relatively sudden death. It can also happen if you get a cut or scrape anywhere.
Because of the correlation between tampons and TSS, individuals and consumer groups like Public Citizen advocated and sued - calling for the regulation of tampons, further research and warning label requirements. Various legal battles ensued over these TSS health concerns, spanning decades and including countless FDA meetings, studies, requests for public comment, back and forth litigation, etc., and finally concluded with labeling terminology we know today, approved in 2001. Yes, the tampon labeling battle spanned over 20 years.
To reduce the risk of TSS, you are supposed to select the lowest possible absorbency to meet your needs, and 8 hours is the maximum time you are supposed to wear a tampon without giving things a break, lol.
Many U.S. hospitals will not provide a menstruating woman in their care with a tampon because of the associated health risks. Again, ridiculous. Hospitals serve up anesthetics, painkillers, dirty Hep C needles from unsavory staff, and drugs that can kill Michael Jackson, but believe the risk-benefit analysis of the tampon is unfavorable? K.

I thought it was fascinating that tampons were so relatively new to the U.S.. It does seem like an obvious and simple solution to a ubiquitous issue. What took so long?

thoughts

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