Wifey wants bolt-ons

[rsg]

Originally Posted by Lisa

Richard, do you know why further surgery is required? Is it mostly because women want different implants, or because of poor placement, or because of CC, or for other reasons?

I don't know the exact reasons but will do a little looking around when I get a chance. What I do know from this particular study is that the population that is in the 20% range is made up primarily of cosmetic patients, while the population closer to the 40% range is made up primarily of reconstructive patients.
So I guess a better way to put it would be that about 20% of the cosmetic patients have another surgery within 3 years and up to 40% of the reconstructive patients have another surgery within 3 years.

[Lisa]

Originally Posted by rsg

I don't know the exact reasons but will do a little looking around when I get a chance. What I do know from this particular study is that the population that is in the 20% range is made up primarily of cosmetic patients, while the population closer to the 40% range is made up primarily of reconstructive patients.
So I guess a better way to put it would be that about 20% of the cosmetic patients have another surgery within 3 years and up to 40% of the reconstructive patients have another surgery within 3 years.

You know, I would love to be able to see into the future - say, in 20 to 30 years or more - to find out what happens to women who elected to get implants for cosmetic reasons. How many surgeries in all did they have? What kinds of problems did they encounter? How many had them removed? How did the problems compare between silicone and saline implants?

Maybe that info is already out there.

And even though a few years back the FDA approved silicone implants again for cosmetic patients, I still wonder how much we really know about what happens to them inside a person's body in the long term. I've heard that eventually many, if not most, of them will leak or rupture, but that it's hard to tell (even with MRI imaging) because they don't "deflate" like saline ones do. So that gooey stuff is in direct contact with the tissues. That would scare me. How can that not be an alarming thing?

This statement directly from a PubMed study of silicone implants:

"CONCLUSIONS:
The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."

[rr-nyc]

Originally Posted by rsg

According to the studies submitted to the FDA 20-40% of ALL implants require another surgery within 3 years.

Originally Posted by Lisa

Richard, do you know why further surgery is required? Is it mostly because women want different implants, or because of poor placement, or because of CC, or for other reasons?

From a basic internet search, reconstructive patients (46% of women with silicone gel implants and 21% with saline implants) underwent at least one re-operation within three years. This isn't very clear since reconstructive patients have a pre-existing condition. It also doesn't state how many are revisions from complications vs revisions from non-implant related issues vs patient initiated revision. The same website states complications from augmentation is less but still significant. Mentor, the leading manufacturer, states 12.5% re-surgery rate

This is what they claim to be the complications within the first 3 years
21% Wrinkled appearance of the breast
13% Needed another operation
10% Loss of nipple sensation
9% Capsular contracture (hardening of breast)
8% Implant removal
7% Asymmetry (breasts look different from each other)
5% Intense, painful nipple sensation
5% Breast pain
3% Implant leaks/deflates
2% Implant can be felt
2% Infection
2% Sagging
2% Scarring complications
2% Hematoma (blood collects around the implant)

[Jocke]

Originally Posted by rr-nyc

From a basic internet search, reconstructive patients (46% of women with silicone gel implants and 21% with saline implants) underwent at least one re-operation within three years. This isn't very clear since reconstructive patients have a pre-existing condition. It also doesn't state how many are revisions from complications vs revisions from non-implant related issues vs patient initiated revision. The same website states complications from augmentation is less but still significant. Mentor, the leading manufacturer, states 12.5% re-surgery rate

This is what they claim to be the complications within the first 3 years
21% Wrinkled appearance of the breast
13% Needed another operation
10% Loss of nipple sensation
9% Capsular contracture (hardening of breast)
8% Implant removal
7% Asymmetry (breasts look different from each other)
5% Intense, painful nipple sensation
5% Breast pain
3% Implant leaks/deflates
2% Implant can be felt
2% Infection
2% Sagging
2% Scarring complications
2% Hematoma (blood collects around the implant)

So 9% are happy?

[Lisa]

Originally Posted by rr-nyc

From a basic internet search, reconstructive patients (46% of women with silicone gel implants and 21% with saline implants) underwent at least one re-operation within three years. This isn't very clear since reconstructive patients have a pre-existing condition. It also doesn't state how many are revisions from complications vs revisions from non-implant related issues vs patient initiated revision. The same website states complications from augmentation is less but still significant. Mentor, the leading manufacturer, states 12.5% re-surgery rate

This is what they claim to be the complications within the first 3 years
21% Wrinkled appearance of the breast
13% Needed another operation
10% Loss of nipple sensation
9% Capsular contracture (hardening of breast)
8% Implant removal
7% Asymmetry (breasts look different from each other)
5% Intense, painful nipple sensation
5% Breast pain
3% Implant leaks/deflates
2% Implant can be felt
2% Infection
2% Sagging
2% Scarring complications
2% Hematoma (blood collects around the implant)

Stats from the makers of the devices... Makes me think about how the makers of SSRIs used to say that 3 percent of patients experience sexual dysfunction..

Wonder how they arrived at the 12.5 percent re-surgery rate? Was this only within a certain time frame after the surgery? Even so, even if you look at the data above with a discerning eye (and would most patients fully understand the implications of these figures?) the odds of having a less than satisfactory experience seem high.

[rr-nyc]

Originally Posted by Lisa

A couple of things about implants done through the belly button - it can only be done with saline implants, far fewer surgeons are willing to do it, and it used to void the implant manufacturer's warranty (though I don't know if this is still true). Apparently the uninflated implants' longer journey might increase the chances of it getting damaged. Also, it's more difficult to get proper placement and pocket dissection when you're working from such a long distance. Finally, if/when you need further surgery, the surgeon will have to go back in through the breast to fix things, so you get scarring anyway.

Also, no one has mentioned yet the incidence of capsular contracture. This is a common complication that happens when the scar tissue capsule that forms around the implants becomes too tight and compresses the implant, creating excessive firmness in the breast, distorting the shape of the breast, and/or causing varying levels of discomfort and pain. According to one study, this happens in 15 percent to 45 percent of breast augmentation patients. More surgery may be needed to relieve capsular contracture, but there are no guarantees that it won't happen repeatedly. It may take months or longer for the effects of capsular contracture to appear.

Fifteen to 45 percent chance of this occuring is pretty high. Something to factor in when weighing the risks and benefits of getting implants.

I stated that the belly button approach is limited to saline in a previous post. Do you have any documentation that states transumbilical method voids the manufacturers warranty? I'm in med device and deal with FDA issues of other implantables and have never heard that an insertion method voids any warranties. If anything, that would fall under user error and has nothing to do with a manufacturer

[Lisa]

Originally Posted by rr-nyc

I stated that the belly button approach is limited to saline in a previous post. Do you have any documentation that states transumbilical method voids the manufacturers warranty? I'm in med device and deal with FDA issues of other implantables and have never heard that an insertion method voids any warranties. If anything, that would fall under user error and has nothing to do with a manufacturer

Right - as I mentioned, I wasn't sure if the warranty was voided. Actually a quick search just now revealed one plastic surgery site that said the TUBA method did void the warranty (Lawler Centre Cosmetic Surgery), but elsewhere read that is specifically does not. It may vary depending on the manufacturer, or I could just be wrong.

PS - I'm not a doctor nor an expert. Please don't hesitate to correct my errors.

[rsg]

Originally Posted by Lisa

Right - as I mentioned, I wasn't sure if the warranty was voided. Actually a quick search just now revealed one plastic surgery site that said the TUBA method did void the warranty (Lawler Centre Cosmetic Surgery), but elsewhere read that is specifically does not. It may vary depending on the manufacturer, or I could just be wrong.

PS - I'm not a doctor nor an expert. Please don't hesitate to correct my errors.

Medical devices/implants are frequently used "off label" without any consequences.

[rr-nyc]

Originally Posted by rsg

Medical devices/implants are frequently used "off label" without any consequences.

Off-label is using a device for something other than its designed and approved indication. The FDA's indications for a breast implant are 1) primary reconstruction, 2) revision and reconstruction, or 3) primary augmentation

Off-label use of a breast implant would be to insert it in your biceps to make them look bigger.

[rsg]

Originally Posted by rr-nyc

Off-label is using a device for something other than its designed and approved indication. The FDA's indications for a breast implant are 1) primary reconstruction, 2) revision and reconstruction, or 3) primary augmentation

Off-label use of a breast implant would be to insert it in your biceps to make them look bigger.

Unless the IFU clearly states the surgical method for which the device is to be placed and the surgeon uses a different method to place the implant. A perfect example would be a device that approved for open procedures but is used percutaneously.

[britincali]

I gotta say girls and guys there is some damn good info in this thread!!!

I knew here would be the place to ask :)

Im gonna sit down with her tomorrow morning and read the whole lot over again.

[TheVTCGuy]

Paul - I found some perfect ones for you. As demonstrated:

Hmmmm.... Now, being a CERTIFED Boob man Lisa... I can definitively say.... yep... Those are fake.

[Lisa]

Originally Posted by TheVTCGuy

Hmmmm.... Now, being a CERTIFED Boob man Lisa... I can definitively say.... yep... Those are fake.

Well, if they're going to be cold and hard, at least they should be refreshing.

[Jocke]

Originally Posted by TheVTCGuy

Hmmmm.... Now, being a CERTIFED Boob man Lisa... I can definitively say.... yep... Those are fake.

They only have fake beer's in San Diego.

[TheVTCGuy]

Originally Posted by Jocke

They only have fake beer's in San Diego.

Jocke Jocke Jocke..... My silly Swedish friend Jocke.... Why not come over to San Diego, we'll sit on the beach and check out all the fake beers walking by

[Jocke]

Originally Posted by TheVTCGuy

Jocke Jocke Jocke..... My silly Swedish friend Jocke.... Why not come over to San Diego, we'll sit on the beach and check out all the fake beers walking by

I'm sure you have love that my best friend.

[Christian B]

My $0.02: I really, really dislike breast implants. Even to the point where I'd rather not date the woman. Small, medium or large; I've never seen/touched an ugly, substandard, not-enough breast in my life. I even know two women who've had breast reductions. To me, all healthy women are beautiful. Healthy minds are sexiest of all!

I've been anaesthetised three times so far, and thoroughly enjoyed the "high" afterwards in every case. But I would certainly not have any unnecessary surgery ever.

[TheVTCGuy]

Anyone else finding it difficult to concentrate on work subjects while glancing at this thread..... ?

[Lisa]

Originally Posted by TheVTCGuy

Anyone else finding it difficult to concentrate on work subjects while glancing at this thread..... ?

Well, the cold beers did it for me. Almost forgot to pick up my daughter from school.

[TheVTCGuy]

Originally Posted by Lisa

Well, the cold beers did it for me. Almost forgot to pick up my daughter from school.

Not the beers, the Breasts! I'm finding it difficult to concentrate at work and keep my mind on .. the... the er uh... task at hand... and... uhm.. to... uh...



I'm sorry, what was the question?

[Johny]

Originally Posted by Lisa

Well, the cold beers did it for me. Almost forgot to pick up my daughter from school.

[Jocke]

Originally Posted by Johny

I believe Lisa's daugther disagree.

[Johny]

Originally Posted by Jocke

I believe Lisa's daugther disagree.

[rsg]

Lisa - Here are a couple of links for you. The FDA site has a lot of good information on the different types of implants.

http://www.fda.gov/MedicalDevices/Pr...ts/default.htm

http://books.nap.edu/openbook.php?re...d=9602&page=R3

[Lisa]

Originally Posted by rsg

Lisa - Here are a couple of links for you. The FDA site has a lot of good information on the different types of implants.

http://www.fda.gov/MedicalDevices/Pr...ts/default.htm

http://books.nap.edu/openbook.php?re...d=9602&page=R3

Thanks, Richard. I hope britincali and his wife will look at that information, too.

[hunz]

Sit your wifey down and tell her she doesn't need them. She's beautiful the way she is. Why put something foreign in her body that could damage her health?

[mcjp6]

Originally Posted by hunz

Sit your wifey down and tell her she doesn't need them. She's beautiful the way she is. Why put something foreign in her body that could damage her health?

+ 1

Cannot argue with that.......

[Johny]

Originally Posted by hunz

Sit your wifey down and tell her she doesn't need them. She's beautiful the way she is. Why put something foreign in her body that could damage her health?

x2. why risk your health?

[Lisa]

Renato, I understand what you mean about implants not being permanent devices nor being marketed as such... but who are the manufacturers marketing to? The physician? Because I would say that the average woman looking into getting implants is not aware of that her implants are not considered permanent. Nor am I convinced that all surgeons will make it very clearly understood. Likewise, I think some patients are not aware that their incision choice can eventually result in their having multiple incisions/scars on their breasts. For example, if they choose an axillary or umbilical incision, are they aware that any subsequent revision can not be done through the old scar/incision site?

Patients don't always know to ask these questions, and I'm not convinced every surgeon will take the time to clearly make this information understood. All the more reason that patients should learn all they can on their own.

[rsg]

Originally Posted by Lisa

Renato, I understand what you mean about implants not being permanent devices nor being marketed as such... but who are the manufacturers marketing to? The physician? Because I would say that the average woman looking into getting implants is not aware of that her implants are not considered permanent. Nor am I convinced that all surgeons will make it very clearly understood. Likewise, I think some patients are not aware that their incision choice can eventually result in their having multiple incisions/scars on their breasts. For example, if they choose an axillary or umbilical incision, are they aware that any subsequent revision can not be done through the old scar/incision site?

Patients don't always know to ask these questions, and I'm not convinced every surgeon will take the time to clearly make this information understood. All the more reason that patients should learn all they can on their own.

Just like in every industry there are very good surgeons and not so good surgeons, the key is to find one who is patient and will answer all of your questions. Each packaged medical device/implant has to have instructions for use included in the packaging, it has been my experience that the IFU gets tossed and the physician is trained by a sales person or clinical specialist.
If you look at the physician labeling for approved implants on the FDA website I linked to above, you will see that they are not recommended for the periumbilical approach. Meaning anyone who uses those implants through that approach is using them "off label".