Product Liability Insurance, A Strange Odor & Back In The Chamber - The Shower Shirt

Lisa F. CritesI was in and out of the hospital within five hours between admission, surgery and recovery. Luckily, no post-surgical drains were needed after this procedure; therefore, less pain and no showering issues.

It was June 2010. The last surgery was complete, though we were holding our breath no infection “reared its head.” My primary care physician had prescribed a two-week course of prophylactic antibiotics one week before undergoing surgery, and around the same time I had completed hyperbaric oxygen treatments. If the infection was coming back, it would happen within three to four days after finishing the final course of antibiotics. During that timeframe, something very odd began happening. So odd, I contemplated not even mentioning, though I was outvoted by my Blog editor. My left armpit (same side as the two previous infections) began protruding an extremely rank odor. Not a typical perspiration odor, but something which smelled comparable to a putrid bacterial infection. I knew not to even mention to Dr. Z. since he had a repetitive habit of blowing me off. I did however speak with my infectious disease physician. With his anxiety already at high levels due to my history, he decided to send me back to hyperbaric treatments for one more week as an additional precautionary measure. Therefore, I had seven more days under an oxygen helmet. I was not happy, but if this is what was required to keep two breasts in place then I was in agreement.

Hyperbarcis - 4                                                            Back In The Chamber

Within that same week I heard from the Anson Group, the organization which had been retained to navigate us through the required FDA procedures. Luckily, we attained a Class 1 Medical Device rating, with no requirement to go through any type of FDA approval process. A nice relief seeing we were still waiting to hear from the Centers for Medicare and Medicaid Services (CMS) on the Healthcare Common Procedural Coding System (HCPCS) process and if we could attain an existing, already approved Medicare code. In addition, we were able to secure product liability insurance through a contact of my Chinese liaison. Another several thousand dollars spent between the FDA research group and the insurance company, but we were now protected from repercussions of litigation and knew where we stood with at least one of the many US government healthcare related entities.

In terms of the strange odor, my clinicians felt it was caused by, or somehow connected to, bacteria being excreted from the previous infections and recent surgery.  Essentially, they had no solid explanation since there were no evidence-based medicine theories on odorous armpits.  I was told to purchase Hibiclens, an extremely potent antiseptic skin cleanser to control the odor. I was also told by more than one physician not to get the soap in my eyes as it could cause blindness. The Hibiclens helped for a few days each time but the odor always came back. The smell was severe for about six months and finally subsided.

Imagine being required to use such a strong cleanser which could cause blindness. What’s more intriguing, would be to explain to someone that complications from breast cancer surgery ultimately led to blindness. 🙂

Stay Tuned,

Lisa F. Crites                                                                                                                                         Shower Shirt Principal/Inventor                                                                                                  Corporate Healthcare Consultant                                                                                       Health/Medical Broadcast Journalist