MAUDE

Today while reading a piece called "Can Tampon Safety Be Regulated?" (Esther Rome and Hill Wolhandler), I learned a new term: DEN, short for Device Experience Network. It was a public record of all the complaints the FDA received about a variety of products. Their website is a headache to try to navigate through, but I finally found some of the reports. Since the book I was reading was published in 1996, DEN must be an outdated acronym and now it's known as something called MAUDE -- Manufacturer And User Device Experience. It's pretty obscure (have you ever heard of it? I sure hadn't.), so I'm sure the reports there are just a tiny sampling of all the problems ladies have had with their tampons.

Many of the reports are pretty mundane, something along the lines of, "consumer required assistance of physician to remove tampon after string had broke," but some of them are pretty gnarly.

• The patient initially went to a medical clinic in 2006 complaining of vaginal discharge with odor. She had no abdominal or pelvic pain and denied any fever or urinary symptoms. She was discharged with a diagnosis of yeast vaginitis and prescribed diflucan (150 mg po x one). The patient returned to the clinic fifteen days later stating that a piece of tampon without a string had been expelled from her vagina the previous day. She presented with vaginal burning and irritation, but denied any abdominal pain, fever, or chills

• Reported that this month-swelling, itching and redness but much greater than last month - swelling, so great consumer states she was unable to walk. This month included both upper thighs and labia.

• Consumer reported that she switched from the regular o. B. Tampons to the silk ease when she couldn't find the regular tampons. She used the silk ease and got very ill within 48 hours and was hospitalized with what the hospital described as a kidney infection. Consumer stated that the doctors eventually traced this kidney problem back to the fact she actually had tss. Consumer stated she was sick for a period of 3 weeks, but is now fine at the time of this call.

• Consumer reported she developed a rash, broke out in hives, and went into shock after using a tampon. Saw physician and received a needle for the shock.

But for the most part, each report is a complaint about the string breaking, or one of the "pledgets" disconnecting and getting stuck in someone, or just general reports about TSS. The manufacturer narrative is almost always "We're awaiting results" or "We tested that lot and nothing was wrong."

Going out on a limb: I don't think you would want to shove any cotton in your vag after you've read about all these malfunctions.