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Not safe enough for cows…but women?

Readers of the Milex website (1) will still find a proclamation there that Milex is a quality driven “private company founded in 1937.” In reality, on February 3, 2004 the publicly traded corporation, Cooper Surgical, bought Milex for $26 million dollars in cash. With this purchase came a history of regulatory problems with one of Milex’s most widely distributed products, Trimo-San Vaginal Jelly.

Trimo-San is marketed as “A Unique Vaginal Product” and a 4-ounce tube sealed in plastic and distributed along with every Milex pessary to prolapsed women throughout the developed world. Trimo-San was reformulated in 1977 to include its primary active ingredient and has remained unchanged since that time.

That active ingredient, 8-hydroxyquinoline sulfate, is one of a family of coal tar derivatives first manufactured in 1899. The compounds from which 8-hydroxyquinoline sulfate is made are known as quinolines and isoquinolines, and are similar in chemical structure to benzene rings.

8-Hydroxyquinoline sulfate is claimed to have antiseptic properties and has been used throughout the past century as a topical antiseptic in livestock and has historically been used in the production of human food, medicine and cosmetics. However, there are currently no FDA approved over the counter (OTC) uses for 8-hydroxyquinoline sulfate. The historically approved uses as a topical skin protectant and antifungal have been withdrawn and are now classified as “Category II” or “Not generally recognized as safe and effective or misbranded.” Only one prescription drug listing exists for human use, which is the injectable form compounded with Indium 111 for radiologic studies.

In 1992, the Cosmetic Ingredient Review Expert Panel reviewed the safety of 8-hydroxyquinoline sulfate for use as a fungicide and bactericide in cosmetic formulations in concentrations less than or equal to 1.0 %. The panel reported that available carcinogenicity data were insufficient to support a conclusion on the safety of this chemical.

Although labeled a “mutagen” by the National Institute for Occupational Safety and Health because it is known to cause genetic damage in human blood cells (2), 8-hydroxyquinoline sulfate is not generally reported as a carcinogen. The International Agency for Research on Cancer states this is because the few studies that have been carried out on 8-hydroxyquinoline sulfate have proven to be “of limited value.” (3)

A 2001 document on the effects of 8-hydroxyquinoline sulfate on livestock prepared for the USDA by the Organic Materials Review Institute states that “Although it is not generally reported as a carcinogen or teratogen, a test of the food additive formerly used as cheese preservative (8-hydroxyquinoline sulfate) found tumors in the bladder, brain, and uteri of rats and mice when administered intervaginally.” (4)

The FDA issued a warning letter to Milex on November 24, 1999 citing several regulatory breeches involving the manufacture of their product. Central to these citations was a review of the labeling of Trimo-San:

“Trimo-San Vaginal Jelly is labeled for use three times daily during the first week of treatment and two times a week thereafter. The labeling does not include any time limit when the product should be used. Based on the intended uses cited above, this product is a drug within Section 201(g) of the Act. We do not have any information which shows that your product or similarly formulated and labeled OTC products were marketed as OTC drugs in the United States before December 4, 1975. We do not know of any substantial scientific evidence that demonstrates that this product is generally recognized as safe and effective for its intended uses.”

No subsequent changes were made in either the formulation or labeling of Trimo-San and in June of 2004 Cooper Surgical petitioned the FDA to include 8-hydroxyquinoline sulfate in the OTC drug monograph for vaginal lubricants and moisturizers. A review of current FDA approved OTC drugs and their active ingredients confirm that Cooper’s request for classification remains denied.

While the 19th century gave rise to the industrial revolution, there was little consciousness into such processes as carcinogenicity. It was during the later half of the 20th century that modern societies began to understand the cause and effect relationship between environmental substances such as quinolines and human cancers. How shocking that in the year 2006 a substance so questionable as to be unregulated by the United States government for topical use on livestock is permitted to exist as the only widely distributed vaginal lubricant prescribed to prolapsed women in unlimited doses!

(1) http://www.milexproducts.com
(2) National Institute for Occupational Safety and Health 1997. Registry of Toxic Effects of Chemical Substances:
http://www.cdc.gov/niosh/rtecs/vc7e09a0.html.
(3) International Agency for Research on Cancer. http://www-cie.iarc.fr/htdocs/monographs/vol13/hydroxyquinoline8.html
(4) OMRI NOSB Tap Materials Database:
http://www.ams.usda.gov/nop/NationalList/ TAPReviews/Hydroxyquinoline.pdf

{ 15 comments… add one }
  • Ann March 8, 2014, 3:14 pm

    First, I’m 69 years old, with a list of chronic problems so long, it would take another email. My OB/GYN retired 6 years ago, so I hadn’t had a PAP smear in years, even though my primary care doctors repeatedly promised,
    “We’ll do that, at your next appt.” but they were always too busy and it didn’t happen, which is one of the reasons I’ve changed doctors twice. I also see 5 specialist, who should work together but don’t always follow-up.
    Yesterday, I finally got an OB exam and was told, “You have a large Cystocele” and he drew a picture, when my bladder looks “U” shaped, bulging into my vagina. Plus, he found a large growth on my Cervix, which required extra effort to locate, so he is doing a biopsy of that. He began explaining what a Cystocele was and got so far, as discussing the problems associated with the mesh supports (surgery) but he got sidetracked, so there was no further discussion. (Typical) He completely forgot, I can’t have “ANY” Surgery, unless I would otherwise die. I have a Protein “S” deficiency, which has caused hundreds of blood clots, so that’s not an option. I even have an old style Greenfield filter in my groin, to stop clots but it’s been clogged, so corollary arteries are the only way that blood gets back to my heart.

    Is it possible that a Stage 2, almost Stage 3 Cystocele could have developed, in just 6 yrs.? I had 3 children vaginally but my longest labor was less than 2 hours. I would have one contraction that broke my water and that’s how I knew I was in labor and rushed to the hospital. My 3rd child was supposed to be induced but I always delivered 7 days, before my due date and day 7 fell on Sunday. When I called the doctor, he wanted to postpone induction till Monday but my son was born 1 hour later and the doctor wasn’t there. So I never had protracted labor or pushing. In addition, I had (1) one miscarriage and (1) one Hydatidiform Mole Pregnancy.
    I saw my OB/GYN every year, until he retired and he never noted any problem.

    I’ve had every symptom, for several years, beginning with chronic bladder infections 5 years ago and nothing I do, prevents another one from happening. I never had a single bladder infections, for 64 years. When I get an infection, it spreads through my body, goes straight to my lungs and puts me in the hospital, on IV antibiotics. Doctors didn’t believe that was causing the problem, until the 3rd or 4th time the two were associated and after I suffered in silence, for 2 years.

    My lungs have failed so many times, I’ve stopped counting. I’ve been on life-long clotting meds for years but was over-prescribed by a specialist and had a hemorrhagic brain stroke, requiring 2 brain surgeries and now I must take 2 different medications, for seizures. It’s a delicate balance, between clots and bleeds, so I check my pro-time at home and must keep the range between 1.8 and 2.0, which is ridiculously tight. I’m already on 19 prescription meds + many OTC meds/supplements, so more pills isn’t an option.

    I had a “Tummy Tuck” in 1996, after finding a reputable plastic surgeon, who knew my risks but claimed, “I was trained at John’s Hopkins and Duke, so I’ve done this surgery thousands of times, on patients with who have similar problems and all have tolerated this well”. He also convinced me to have breasts reduction surgery and Lipo Suction, at the same time and wanting my body back, I dumbly agreed. I almost died, I was in ICU for 2 weeks and 2 more weeks in step-down, then a regular room and their only explanation is that a Fat Embolism caused my lungs to fail, with ARDS. After I was finally well, all of the incisions had to be re-done but under local anesthesia. That was the first or (4) four times that my family has been told, “She won’t live long. You might want to begin funeral arrangements”.

    Based on the above information and since I’m old, will your “postural” based practices help me or am I beyond help?

    Ann

  • Joanie August 4, 2013, 5:42 pm

    What can be used in place of trimosan when inserting pessary?

  • Julie March 17, 2013, 12:51 pm

    I had a friend tell me years ago that the content of diapers was carcinogenic and the truth was not being told, nor was the effect of long-term use known. Now that I have been using Poise pads for years I wonder if the same is not true of them. Is there any research research known in that area? My doctor has recently told me I have tiny cysts, each originating at a small hair. Is there any connection ?

  • Tracy Louise January 3, 2013, 10:09 pm

    Not many comments over the years here about Trimosan. I have used in for several years, mostly without the pessary, as it is not fitting well anymore. I find the adherent properties of the gel are a help to keeping my vaginal walls “tucked in place.”

    My GYN explained the purpose of Trimosan was to keep the pH of the vagina at the proper level to keep the wrong bacteria from growing. I’m not sure that plain old KY jelly has that property.

    Other than my prolapse, I’m healthy otherwise; but I’ll give some thought to the continued use of Trimosan.

    Thank you for being an alternate voice in these discussions to the medical community.

  • pattileigh March 14, 2010, 7:47 pm

    Trimo san
    Submitted by pattileigh on January 10, 2009 – 12:11pm.
    I used Trimosan for 4 years {1998-2002} and had the same discharge. I thought I was doing my vagina good using the product recommended for my pessary and was told many times regulr lubricants were bad for my pessary. I went to alot of trouble to find it for a few years and it doesn’t come cheap. Then after 2002 I couldn’t locate it in even in a bigger town or online. This product caused alot of itching after awhile and was told in 2003 I had a bad Pap smear something I never had ever in 25 yrs. of smears. Well since then I have never had a bad one and I had stopped this product. I have no clue if it was the cause. In 2006 I was told I had thyroid cancer and an immune system disorder with heavy antibodies. I don’t think the thyroid cancer was caused by the product..

  • nick March 14, 2010, 7:46 pm

    Regardless of what we hear,
    Submitted by nick on June 16, 2008 – 10:21am.
    Regardless of what we hear, i’m always researching what my baby is prescribed and as much as i dont like giving him drugs until he’s older if he’s sick he’ll have to take them. I eat healthy exercise etc and do fine every year no flu no colds etc. These docs dont have a clue as to what their prescribing the doctors get told by drug companies what the drugs do they prescribe them sold. It amazes me more people aren’t in drug rehab on the account of the stuff they write scripts for.

  • louiseds March 14, 2010, 7:46 pm

    Lubricants
    Submitted by louiseds on January 5, 2008 – 10:27pm.
    Hi Greenone

    Just wondering if a bacteriostat is a good thing to be using in your vagina in the longer term?? I can see that it is probably good surgery hygiene for the doctors’ surgery, but would be wary of its potential resistance effect on vaginal microflora when I am the only one using it.

    The good bacteria are are critical for vaginal health, but wouldn’t a bacteriostat discourage them, and also potentially build up resistance in any bad bacteria that find their way in there, eg e. coli? I think I would prefer to use one that had as little effect as possible on my microflora, eg standard KY gel or something similar.

    Cheers

    Louise

  • Christine March 14, 2010, 7:45 pm

    parabens and pessaries
    Submitted by Christine on January 5, 2008 – 8:06pm.
    Hi Greenone,

    Thanks so much for joining this revolution in women’s health!

    Type “parabens” into the search engine on the left of the screen and you should receive some valuable information.

    I would take pessaries over surgery and posture over pessaries. But if you can find a comfortable pessary that reduces your symptoms, you may be able to wear it for years with no exacerbation of your condition.

    🙂 Christine

  • greenone March 14, 2010, 7:45 pm

    Trimo-San and other lubricants
    Submitted by greenone on January 5, 2008 – 6:51pm.
    Hi Christine,
    I have just recently joined, and would like to thank you for your comments on Trimo-San. I used it as a pessary lubricant for 4 years or more. I experienced intense vaginal irritation which I questioned various Doctors about. Some suggested it was meno pausal hormones, other suggested using an anti itching cream.
    My present Doctor, who really wants me to have surgery for a prolapsed bladder, suggested I just use Lubricating Jelly. She uses it in her office for rectal and vaginal exams. It is put out by Health Care Plus and is a Bacteriostat. The preservatives listed in it are Methyl paraben and propyl paraben. There are no other ingredients listed.
    I have been using it for over one year now. I have had no vaginal irritation with it. My last period was eight months ago, so I’m not sure if the irritation was indeed caused by “hormones” as I approach meno pause.
    What is your opinion of using this lubricant for a pessary wearer? What do think of my Doctor’s opinion that a pessary is a foreign object and not good for me? She has suggested surgery several times but your comments have kept me from having this done.
    Thank you.

  • louiseds March 14, 2010, 7:44 pm

    Vaginal lubricant / Better sex
    Submitted by louiseds on July 7, 2006 – 5:53am.
    Hi Rosemary

    There are a few topics scattered through the Lifestyle forum that touch on lubricants. I am about to put a new topic re ‘better sex with prolapse’in the Lifestyle forum so we can get all those sex-type questions into one space.

    Cheers

    Louise

  • WIcheesehead March 14, 2010, 7:44 pm

    Trimosan and Cancer
    Submitted by WIcheesehead on May 6, 2006 – 1:49pm.
    Thanks Christine for your detailed info on Trimosan beeing a possible carcinogen. I have been treated for non-Hodgkin’s Lymphoma since I started using Trimosan. I am serious about investigating whether the Trimosan is the cause of my cancer. Could you give me suggestions about how to go about doing this? Should I contact someone in the government? or a lawyer who specializes in these cases? Does anyone have any referrals? My email is: mary.ellen@sbcglobal.net (if anyone wants to send it privately) Thanks.

  • louiseds March 14, 2010, 7:43 pm

    Safe for cows but not for women
    Submitted by louiseds on May 2, 2006 – 9:13am.
    I didn’t post before, because I wasn’t really surprised. Very annoyed, but not surprised. I have no reason to believe that a pharmaceutical company promoting its human health product would mention to a doctor facts that are of veterinary interest, especially if the doctor doesn’t ask “Is it safe for cows?” What doctor would be interested unless she was planning to use it herself. And it would be a pretty random question to ask a rep.

    And I wasn’t surprised that the USA national regulator failed to notice the discrepancy, as their job is so big. What’s one little discrepancy? =:-O Call me a cynic if you like. I think maybe I am just getting wiser after sorting out family health problems all these years, and discovering that ultimately I have to be the one to decide whether a treatment or drug is OK for me or my family members, not the doctor who is basically just promoting others’ products when he says, this or that cream is best. That is not meant as a dig against doctors. It is just that a lot of the detailed information about drugs is not displayed up front, and I think many doctors are swayed by promotion, rather than doing an audit on every drug they are asked to prescribe. They are doctors, not auditors, and there has to be a degreee of trust in all this. Doctors are a great place to start, but I don’t think we should take their opinion as the final word.

    God gave us freedom to choose and a brain to use, and now, thanks to Christine, I won’t be using Trimosan.

    Cheers

    Louise

  • AnnW March 14, 2010, 7:42 pm

    unbelievable
    Submitted by AnnW on May 1, 2006 – 9:24am.
    This astounds me and really makes me want to research every single thing my doc and my baby’s doc prescribes. I had an OB appt. last week and saw Trimo-san sitting on the counter. Clearly it’s still used. And this is at UCSF! I wonder when/if this research will make it to the medical world.
    Ann

  • virgo46 March 14, 2010, 7:42 pm

    Hi, I love the site. What is
    Submitted by virgo46 on April 30, 2006 – 8:59am.
    Hi, I love the site. What is a good vaginal lubricant? Also to all the posture works. I have your book and video and my body knows when
    I am not using the posture. It’s been about a year doing the exercise and learning to be mindful of my body. I stopped eating meat in sept. my family and friends think I’m nuts but I feel good and that’s what matters. Looking foward to your new video.
    Thanks
    Rosemary

  • AmyS March 14, 2010, 7:41 pm

    Trimo-san
    Submitted by AmyS on April 25, 2006 – 8:10am.
    Wow, and they said this would give the proper PH balance. Good thing I couldn’t find it after I ran out. I did notice that I had a funny discharge, kind of like cottage cheese, when I used that and not with regular lubricants. My doctor never said anything about the discharge, I didn’t have an infection.

    Thank you so much for being brave and telling the truth. You are such an inspiration and comfort to us.

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