2004N-0556
  

  
 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC27
  



  

  
Submitter : 
  

  
Mrs. Patricia Morris
  

  
Date & Time: 
  

  
02/17/2006 01:02:47
  



  

  
Organization : 
  

  
Mrs. Patricia Morris
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Fully inform people. Tell people to wash their hands before and after putting on a condom and between touching one part of a body and another. Instead of that strange language you use to mask what really happens, tell people that various STDs can be put in their eyes, nose, mouth, plus all other moist opennings, holes and cuts, not just the sexual ones. Do you mean to stop transmission of disease or not?   



Touching a sore as in 'feeling up' and then touching your eye can transmit gonorrhea and chlamydia, herpes and even the human papillomavirus (HPV) to the eye. One does not need to go all the way for this to happen. Putting on or taking off a condom would not stop this transmission from happening. References follow at the end.



That is a pretty big condom that will stretch from the eyes to the thighs plus covering your hands. Does not sound safe. How does one breath? It is odd .. and telling ... that when 'safer sex' is taught, washing hands is not mentioned.

 

1.) "Eye Disorders Venereal Eye Disease" http://www.perret-optic.ch/optometrie/pathologie_oculaire/patho_venerienne/patho_vene1_gb.htm:



"Chlamydia ... Ocular spread occurs in about 1 in 300 cases of genital disease.



Herpes ... Both strains can cause eye disease by direct infection.



Gonorrhea ... Ocular infection with gonorrhea is usually by direct hand to eye spread. 



Lice ... Oddly enough, the species of lice which can reside on the eyelashes is the same as that found in the pubic region, the "crab louse" (Phthirus pubis). Thus, this can be considered a venereal disease, and is usually acquired from sexual contacts."  

 

2.) "Herpes Simplex - Other Forms of HSV-1 and HSV-2 Location and type" http://www.morehead.org/wellconnected/000052.htm: "An estimated 400,000 Americans have recurrent ocular herpes, with 50,000 new cases occurring each year." 

 

3.) "Biology and pathological associations of the human papillomaviruses" Cheah PL, Looi LM Department of Pathology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10879257&dopt=Abstract "(L)esions reported to be HPV- associated are: papillomas, dysplasia and carcinomas in the nasal cavity (HPV 6, 11, 57); squamous papilloma, condyloma acuminatum, and verruca vulgaris of the oral cavity (HPV 6, 11), oral focal epithelial hyperplasia (HPV 13, 32); warty lip lesions (HPV 2): and conjunctival papillomas (HPV 6, 11).?




  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 4.) Slide 23 of the CDC's "Ready-to-Use STD Curriculum for Clinical Educators Human Papillomavirus (HPV)" Module for July 2004 http://www2.cdc.gov/stdtraining/ready-to-use/Manuals/hpv/hpv-notes.doc :



" a) Genital warts appear ... (lots of sites listed plus the following) 



    2)  Pubic area, upper thighs, or crural folds in men and women ... 



    e) HPV types causing genital warts can occasionally cause lesions on oral, upper respiratory, upper GI, and ocular locations."  



5.) "Detection of human papillomavirus DNA on the fingers of patients with genital warts." Sonnex C, Strauss S, Gray JJ. Sex Transm Infect. 1999 Oct;75(5):317-9. http://sti.bmjjournals.com/cgi/content/abstract/75/5/317 

"CONCLUSION: This study has identified hand carriage of genital HPV types in patients with genital warts."



6.)  Contamination of environmental surfaces by genital human papillomaviruses S Strauss, P Sastry, C Sonnex, S Edwards and J Gray http://sti.bmjjournals.com/cgi/content/full/78/2/135?ijkey=4b7cd9924ab3dccda2d84b73cbd037cb6f6140bd "All identified HPV types detected in the treatment rooms were mucosal HPV types, ruling out the possibility of contamination from cutaneous wart virus. HPV DNA detected on the bed control panel, light switch, and the colposcope handle were much more likely to indicate contamination from the doctor's gloved hands after he/she had examined the patient." Note: Gloves Transmitted.



Patricia Morris

Palm Springs, FL 33461

patrose@angelicisp.com