{Reference Type}: Journal Article
{Title}: FDA investigates complaint of pain in spermicidal condom user.
{Journal}: Contracept Technol Update
{Volume}: 5
{Issue}: 3
{Year}: Mar 1984
暂无{Abstract}: Currently, the US Food and Drug Administration (FDA) is investigating a complaint that the Ramses Extra spermicidal condom may have caused severe pain in a user.  The condom, which received marketing approval from FDA in 1982, contains the spermicidal lubricant nonoxynol-9, which reduces the number of active sperm and consequently decreases the risk of pregnancy.  Lee Mathews of the FDA's office of compliance is investigating the complaint, filed in August 1983.  The man experienced "excruciating pain" on urination after using the spermicidal condom, according to FDA documents.  The woman indicated in the complaint that the pain possibly resulted from the condom's spermicide entering her husband's urethra.  The pain subsided after several hours.  She reported that her husband had never used the spermicidal condom before and had no known allergies or sensitivities.  A spokeswoman for the manufacturer, Schmid Products, Company, reported after investigating the complaint that the company saw "no reason to believe that there was a batch problem or a problem with that particular condom."  Company records revealed no other complaints with that batch.  No other samples were available for testing from the woman filing the complaint, but "the fact that the wife did not have a problem also indicates there wasn't anything particularly wrong with that condom."  Company officials did not interview the man who used the condom in question, but they did reply to him in writing and have heard nothing more from the couple.  The Schmid spokeswoman indicated that there have been isolated instances of sensitivity to this product.  A key factor behind FDA approval of the spermicidal condom was a study completed for Schmid by Dr. Edwin Dale.  Dale's study involved 30 men, 19-46, who used both regular condoms and condoms treated with nonoxynol-9.  He concluded that decreased sperm motility with the treated condoms was caused by cell fragmentation due to cell membrane disruption.