Susan's Place Transgender Resources

There was an old thread about this from 2015, and it is recommended to me to start a new one.
Here we go!
IYesterday I removed my first one week estradiol patch,  (generic version from Mylan), and wonder over wonder, i had the identical skin rections mentioned in the 2015 thread.  Skin reddening and blistering.  Having earned my living inside the laboratories at which transdermal patches and skin adhesives were invented, I knew immediately a faulty/wrong skin adhesive is used with these patches (probably made in China to be cheap).
I did not see any action people had taken in the 2015 thread, but I for sure will not pay high copays (over $65) for a medication delivery system that hurts me!

I contacted the manufacturer (they don't even have a hotline, or any line that is monitored over the weekend) to inform them about the reaction, and I will inform the FDA about it.

In the meantime I would like to warn every person here not to use those Mylan estradiol patches if you find the slightest skin reaction.  The transfer rate of the medication will be much higher if the skin is damaged, and it can lead to undesired levels of estrogen in your system.
Talk with your doctor to prescribe a different estrogen delivery system!

I used the Sandoz patches and had lint rings around the edges and a slight pink tint on the skin where the patch sat. Rubbing alcohol took care of the lint rings, and the skin irritation was minor enough to overlook. I hope you get things sorted out soon.

Hugs Devlyn

Quote from: Devlyn on November 17, 2018, 01:18:57 PM
I used the Sandoz patches and had lint rings around the edges and a slight pink tint on the skin where the patch sat. Rubbing alcohol took care of the lint rings, and the skin irritation was minor enough to overlook. I hope you get things sorted out soon.

Hugs Devlyn

The lint ring is just that, lint that adhered to the exposed edges of the patch.  I see it as normal that some adhesive transfer from the patch to the skin occurs at the edges of the patch.  The skin irritation could have been caused by the transfer of the medication into the skin.
I have blisters, and that is not minor anymore!  I reported the skin reaction to the FDA, and we have to see what comes out of it.  Similar reactions were mentioned in the 2015 thread, but if nobody reported them and complained, the company would not have any reason to change their adhesive composition!

Dietlind,

Thanks for doing your bit for others.  The squeaky wheel gets the grease.  So, keep squeaking.  For everyone willing and able to squeak, there are likely many others who, for whatever reason, go unheard.

I hope you find what you need for yourself in the way of a suitable delivery system.  When you have, don't forget to keep squeaking.  All for one and one for all!

Thanks,
Stevi 

Not sure if it's of use to anyone but I'm using a brand called Vivelle Dot, and I haven't had any issues.

Quote from: Devlyn on November 17, 2018, 01:18:57 PM
I used the Sandoz patches and had lint rings around the edges and a slight pink tint on the skin where the patch sat. Rubbing alcohol took care of the lint rings, and the skin irritation was minor enough to overlook. I hope you get things sorted out soon.

Hugs Devlyn

The same for me.

The kind/brand of patch you get depends largely on what your relative health insurance has on their Formula

Some skin adhesives are more aggressive than others.  The developers of skin adhesive have always to juggle between adhesion and skin compatibility (they all started out with an adhesive similar to that on Post It notes).

Skin sensitivity is also a point whether the adhesive or a patch will blister you skin.  As an Intersex person, I never developed the more rugged adult skin structure, and my skin is still as sensitive as that of an infant.
Nevertheless, the manufacturer should have submitted data for persons like I, to get FDA acceptance for their patches.  If they did not do that, they should have a clear warning on their product that it is not suitable for persons with sensitive skin.  Such warnings are absent from the packaging, and that is the reason that I alerted the FDA about the skin blistering problem!

Dietlind dear, you are such a gift to this forum!   Sharing your expertise is a real help.  My Estradiol patches are made by Janssen Pharmaceutica in Belgium.  I use <dosage removed by moderator> patches changed twice a week.   I have no major skin problems, sometimes minor reddening, but always have is a ring of lint around the edges.   Others have complained that they do not adhere well and have to add tape.  I actually find them hard to remove. I have found that eye makeup remover works well for removing the lint-glue ring after removal.


< No dosages please - Susan's Terms of Service #8C (https://www.susans.org/forums/index.php/topic,2.0.html) >

Quote from: Dorit on November 18, 2018, 11:49:50 AM
Dietlind dear, you are such a gift to this forum!   Sharing your expertise is a real help.  My Estradiol patches are made by Janssen Pharmaceutica in Belgium.  I use <dosage removed by moderator> patches changed twice a week.   I have no major skin problems, sometimes minor reddening, but always have is a ring of lint around the edges.   Others have complained that they do not adhere well and have to add tape.  I actually find them hard to remove. I have found that eye makeup remover works well for removing the lint-glue ring after removal.


< No dosages please - Susan's Terms of Service #8C (https://www.susans.org/forums/index.php/topic,2.0.html) >

Thank you for the compliment!  I just try to help out with my knowledge where I can.  I made my living with this stuff, respectably shared lab space with some of the researchers/developers of other things.

I don't know the individual suppliers of skin patches, and the ones one gets are depending very much on the pharmacies/health insurances.  All follow the same mechanics that were initially discovered and developed in our labs.  The patch adheres with specific skin adhesives, and embedded in these adhesives are micro spheres that have the medication encapsulated.  The spheres are designed in such a way that they release the medication over a controlled period of time.
Some people are more sensitive against skin adhesives than others,  I am very sensitive, and a manufacturer should provide a warning for this.
Adhesive transfer around the edges of a patch is pretty normal, and this adhesive catches lint, etc.  To use eye make up remover for this adhesive is a pretty good idea, because the eye lids are commonly very sensitive, and if the remover will not bother them, it should not bother the skin at the patch site either!

While we're on this subject of Estradiol patches, do you all think that soaking in a bath affects the patch effectiveness? I'm a little concerned that maybe the heat from the water some how affects the absorption.

Quote from: gracefulhat on November 18, 2018, 11:05:51 PM
While we're on this subject of Estradiol patches, do you all think that soaking in a bath affects the patch effectiveness? I'm a little concerned that maybe the heat from the water some how affects the absorption.

That should not be a problem, because the medication is micro encapsulated.  As long as the patch is solidly attached to your skin, water cannot float the micro beads away.  Your water is hardly warmer than you body temperature.  Adherence is the name of the game here.

Quote from: Dietlind on November 18, 2018, 11:08:49 PM
That should not be a problem, because the medication is micro encapsulated.  As long as the patch is solidly attached to your skin, water cannot float the micro beads away.  Your water is hardly warmer than you body temperature.  Adherence is the name of the game here.

Thank you! I've been very concerned about this. Ok, one more question. I've been cheating a little by keeping the patch on for a week and overlapping with the 2nd patch for 3 or 4 days. I know everyone will think I'm crazy but after reading the drug trial information it showed that the drug effectiveness was still as high on the 4th day as the 3rd, which tells me theres still probably alot of the med on the patch for a few more days following, even though the trial only was for 4 days. So, lol, what is your oppinion on this?

Quote from: gracefulhat on November 18, 2018, 11:16:48 PM
Thank you! I've been very concerned about this. Ok, one more question. I've been cheating a little by keeping the patch on for a week and overlapping with the 2nd patch for 3 or 4 days. I know everyone will think I'm crazy but after reading the drug trial information it showed that the drug effectiveness was still as high on the 4th day as the 3rd, which tells me theres still probably alot of the med on the patch for a few more days following, even though the trial only was for 4 days. So, lol, what is your oppinion on this?

I am neither an endocrinologist, nor an internist (I am mainly specialized in infection control & prevention), but logic tells me that you get the double dose of estrogen for the days you overlap.  Too much of the good stuff can be simply too much.  It depends on your blood work to see if this is a good idea or not.  Your doctor had a reason to prescribe the patch you have, and you override the reason he/she had, and that is never a good idea!

Quote from: gracefulhat on November 18, 2018, 11:16:48 PM
Thank you! I've been very concerned about this. Ok, one more question. I've been cheating a little by keeping the patch on for a week and overlapping with the 2nd patch for 3 or 4 days. I know everyone will think I'm crazy but after reading the drug trial information it showed that the drug effectiveness was still as high on the 4th day as the 3rd, which tells me theres still probably alot of the med on the patch for a few more days following, even though the trial only was for 4 days. So, lol, what is your oppinion on this?

If you have an artificially high reading from double patching, your doctor won't adjust your dose upwards because you already have good levels..... and you'll be locked into wearing two patches and a more complicated ritual of applying and removing patches. Take your medicine as prescribed, and remember, it's long-term exposure to estradiol in female ranges that performs the magic, not jamming as much E as you can into your system.

Full disclosure, I did the same thing for awhile, until I figured out what I just told you.

Hugs, Devlyn

Thank you all ><

If the patch is designed to be worn 3.5 days, then the manufacturer can only guarantee the dose indicated on the patch will be released daily for those 3.5 days, after that, who knows?! It's less reliable. So if you keep it on, you don't necessarily get the double dose but definitely more.

Was just contacted by the clinical QA group of Mylan.  A FDA case has been opened for this complained.

I have a case number and a phone number for the clinical group.

Skin rashes are indicated on the possible known problems.  However, blistering is not listed. 
If anybody here has developed blisters from the patch (blisters are defined as elevated skin sections that are normally flat), please contact me and I provide you with the case number and the telephone number to report your case.

The more cases are reported, the better is the chance that the FDA will require them to change their formula!

The only time I double up patches is if I am a day or more late changing it.  Then, I will resume my regular schedule at the next opportunity, but keep the late patch on for its full 3.5 days.  That hasn't happened for quite a while now.  I guess after two years, it gets to be a habit. :)

I try to avoid getting mine too wet in the shower. 

It is really important when applying the patch to make sure that there are no wrinkles around the edges.  Wrinkles allow water under the patch, and then the adhesion is gone.  This comes down to getting really good at applying them.  I use the generic from Sandoz, and its adhesive only allows one stick.  If you get the positioning wrong, or if you get a wrinkle, you can't reposition it: it just won't stick a second time.

There was also a bad batch this past summer.  I had a couple of boxes where none of the patches would stick well.  Someone else complained about the same thing, so it wasn't just my imagination.

Quote from: KathyLauren on November 19, 2018, 09:27:53 AM

I try to avoid getting mine too wet in the shower. 

It is really important when applying the patch to make sure that there are no wrinkles around the edges.  Wrinkles allow water under the patch, and then the adhesion is gone.  This comes down to getting really good at applying them.  I use the generic from Sandoz, and its adhesive only allows one stick.  If you get the positioning wrong, or if you get a wrinkle, you can't reposition it: it just won't stick a second time.

I put surgical tape (Micropore) around the edges.  This tape is designed to stick under wet conditions!

Quote
There was also a bad batch this past summer.  I had a couple of boxes where none of the patches would stick well.  Someone else complained about the same thing, so it wasn't just my imagination.

Whenever you have problems of this kind, it is important to contact the hotline of the manufacturer.  These patches are medical devices and are under the control of the FDA.  The manufacturer has to open up a FDA case if complains coming in!  If the FAD feels that there is a problem (depending on the number of the complains), it requires the manufacturer to redesign the product and provide data on the redesign to the FDA!

Had more conversations with the Quality Control Group of Mylan.  They will supply my with new patches from a different lot number, and retrieve my patches so their lab can do some testing with them.
I appreciate it a lot that they are very responsive, and I hope that they ill find the reason for the blistering and can correct it!

To update this.  Mylan worked with my local pharmacy to send new patches of a different lot number, and to retrieve my current patches for QA testing.  I am wearing the new patch now and have to see if the blistering was a one time problem or if they have a general problem with their skin adhesives.

I have to say that they were very responsive and proactive once I had established contact with them!

They old me that they did not receive any complaints in 2015 and 2016, which means, none of the people that were experiencing skin problems with the Mylan patches  in 2015 reported any of this to either the company or the FDA.

No manufacturer can do quality improvements if they do not receive any information on quality problems.

It is very essential to report problems with medical devices and /or equipment to the manufacturer or the FDA!

I just have to say I love your new avatar!   So different from the previous one.     Apparently you are experiencing positive changes!

Quote from: Dietlind on November 24, 2018, 12:01:04 AM
To update this.  Mylan worked with my local pharmacy to send new patches of a different lot number, and to retrieve my current patches for QA testing.  I am wearing the new patch now and have to see if the blistering was a one time problem or if they have a general problem with their skin adhesives.

I have to say that they were very responsive and proactive once I had established contact with them!

They old me that they did not receive any complaints in 2015 and 2016, which means, none of the people that We're experiencing skin problems with the Mylan patches  in 2015 reported any of this to either the company or the FDA.

No manufacturer can do quality improvements if they do not receive any information on quality problems.

It is very essential to report problems with medical devices and /or equipment to the manufacturer or the FDA!

Assuming there were other people who had problems that they deemed significant enough to report. You are the first person I've heard of that experienced blistering, and I've heard a lot of concerns about a lot of things over the years here.  :)

Hugs, Devlyn

Quote from: Devlyn on November 24, 2018, 02:58:32 AM
Assuming there were other people who had problems that they deemed significant enough to report. You are the first person I've heard of that experienced blistering, and I've heard a lot of concerns about a lot of things over the years here.  :)

Hugs, Devlyn

There is a thread here on the forum that was from 2015, and several writers complained about blistering with the Mylan patches.  That caused me to do a Google search, and I found more evidence about this.

But the main thing is that persons, who experience negative effects from any medical device,  which is patient applied (patches fall under the medical device laws), should contact either the FDA (they have a rather simple online reporting form), or the manufacturer of the device (they are required to have a reporting system staffed with medical personnel)

Quote from: Dietlind on November 24, 2018, 08:21:00 AM
There is a thread here on the forum that was from 2015, and several writers complained about blistering with the Mylan patches.  That caused me to do a Google search, and I found more evidence about this.

But the main thing is that persons, who experience negative effects from any medical device,  which is patient applied (patches fall under the medical device laws), should contact either the FDA (they have a rather simple online reporting form), or the manufacturer of the device (they are required to have a reporting system staffed with medical personnel)

I think most people are going to report an issue like this to their primary care physician, who would likely try another product on them. I pointed out the pinkish atea to my doctor and she said we could try another patch if it bothered me.

Quote from: Devlyn on November 24, 2018, 08:30:44 AM
I think most people are going to report an issue like this to their primary care physician, who would likely try another product on them. I pointed out the pinkish atea to my doctor and she said we could try another patch if it bothered me.

And this is the problem.  Many docs don't report it either, and the manufacturer never finds out of possible problems.

I cannot recall that we ever received a single problem report from a physician for any skin applied products (almost all skin adhesive used for any product from any company is manufactured by my employer)

Quote from: Dietlind on November 24, 2018, 08:49:22 AM
And this is the problem.  Many docs don't report it either, and the manufacturer never finds out of possible problems.

I cannot recall that we ever received a single problem report from a physician for any skin applied products (almost all skin adhesive used for any product from any company is manufactured by my employer)

Fair enough. You have experience and a connection to the industry and methods. For the consumer, we just want a product that works for us.  :)

Quote from: Devlyn on November 24, 2018, 09:19:51 AM
Fair enough. You have experience and a connection to the industry and methods. For the consumer, we just want a product that works for us.  :)

And that is the reason why I started this with Mylan.  The outcome should benefit all of us.

But I also want to raise awareness that all FDA registered products require the manufacturer to establish a problem reporting system.  The more people use these systems, the better products we will receive!

If anybody does not feel comfortable with reporting some problem, they can PM me and I help them do handle this!