What Causes the Mold Found in Saline Implants?

I have heard several ladies say that they had been sick due to the mold exposure found on, or in the saline implants. Is this due to the ps not using sterile water? What causes this, and how can I prevent this?

Doctor Answers 6

The Truth About Mold in Saline Breast Implants

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Recently, there has been a lot of chatter about fungal (or mold) infections in saline-filled breast implants. In fact, I have had a few patients contact me with concerns regarding this. The fundamental question: Should you be worried about having a fungal infection or mold in your saline breast implants?

For almost everyone the answer is a resounding “No!” However, if you asked whether this has ever happened, the answer is “yes.” To understand how this happened and the chances of it happening in the future requires both a review of recent history and a knowledge of how exactly saline implants are filled.

Let’s look at what happened.
Back in 2001, there was a cluster of fungal infections of saline-filled breast implants. Interestingly, I was asked to review the index case for this, so I have seen the original documents and can comment intelligently.

These infections occurred in a single surgery center. Further, it was discovered that these infections occurred in a single operating room of that surgery center, and the risk of infection was greater if the operation took more time in that particular room.

Understand how saline implants work.
To get the significance of this, you need to understand something about saline breast implants. They are filled with sterile saline through a tube that is connected to a valve in the implant at the time of surgery, unlike silicone implants which are pre-filled and have no valve. Many years ago (as in over 25 years ago), the way this was done was by filling a syringe with saline that was in a sterile pitcher on the operative field, connect the syringe to the tube going into the implant, and fill the implant. This would be done multiple times until the implant was filled to the appropriate volume; then the tube would be removed. This became known as an “open bowl” technique.

The closed technique for filling saline breast implants.
About 25 years ago, a new method of filling the saline implants was adopted. In this, sterile tubing is connected to an intravenous bag of saline (obviously sterile), and through this tubing the saline was drawn up into a syringe via a stopcock transferred into the implant by the tubed connected to the implant’s valve. This is known as a “closed” technique because the saline is never exposed to the outside environment. Sterile saline, sterile tubing, sterile implant — Do you see where I’m going with this?

Fungal infections were caused by the open-bowl technique, which is now obsolete.
Let’s go back to the surgery center where these cases were found. There was a major concern about what was causing these infections so a thorough investigation was conducted. They found that there was water damage to the ceiling of a storage area adjacent to the operating room where these cases occurred. This caused mold or fungus growth. This fungus got into the air and landed into the open pitcher (open bowl) of saline on the sterile operating field, and thus contaminated the saline that was being used to fill the implants. So basically, airborne fungus contaminated the saline used to fill the implants: contaminated air, contaminated saline, contaminated implants.

Saline breast implant best practices
It is currently considered the “best practice” (and I would go so far as to say the standard of care) to use the closed method for filling saline breast implants. Certainly most Board-certified plastic surgeons would agree with me — perhaps all of them. Even before these fungal infections happened in 2001, most of us had already switched to a closed technique.

Before 2001 there had been a very few, isolated cases of the same fungal contamination of the saline. In response, the breast implant manufacturers produced the tubing necessary to allow a closed system of filling the implants. This was a very proactive move, which is typical of the major implant manufacturers: Allergan (Formerly McGhan) and Mentor.

Should you be concerned about mold in saline breast implants?
The overwhelming majority of women with saline implants have nothing to worry about in regards to this. But, if you are considering saline implants, be sure to ask your surgeon whether he or she uses a closed technique to fill the implants. If this is the case, the risk of a fungal infection approaches zero.
If you have had saline implants for many years, and you are concerned about your implants, the best thing to do is to contact your plastic surgeon and ask how the implants were filled. This fact should be recorded in the surgeon’s operative report. But the overwhelming likelihood is that there is no problem.

Knoxville Plastic Surgeon
4.9 out of 5 stars 111 reviews

What Causes the Mold Found in Saline Implants?

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No one knows for sure but the hypothesis is that it comes from the air when implants are placed or filled and therefore closed systems are recommended to decrease this potential source

Otto Joseph Placik, MD
Chicago Plastic Surgeon
4.9 out of 5 stars 86 reviews

Mold in Saline Implants

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Having mold grow inside of saline implants is highly unlikely and very rare. I have never seen a case in my practice but it can happen. There are two ways that saline is put into implants. This first method is an open fill system where sterile saline is poured in a sterile container on the surgical field and is exposed to air. It is then drawn up via a syringe and injected into the implants. Even though the solution and field are sterile, it is the exposure to air that can lead to mold formation in the implant. The second and more common method is to use a close filling system where the saline goes directly from a closed IV bottle into the implant through connected tubing. This method is more sterile since the saline is not exposed to the air, highly minimizing the risk of mold formation. If the implant is placed correctly and using sterile technique the risk of mold formation is extremely rare. Make sure that you have procedures completed by a board certified plastic surgeon to further minimize this risk.

Mold and implants

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I have never seen mold in any implant removal that I have performed or any infection that I have treated.  But it has been reported.

Steven Wallach, MD
New York Plastic Surgeon
4.2 out of 5 stars 30 reviews

Cases of Mold found in Breast Implants

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Regarding :''I have heard several ladies say that they had been sick due to the mold exposure found on, or in the saline implants. Is this due to the ps not using sterile water? What causes this, and how can I prevent this?" 

Your question refers to press blitz from a few years ago. Never since repeated. There has been a surgeon in the Atlanta area who made it a cause celebre but whose experienced has NOT been matched by any other Plastic surgeon I know.

In all my years of plastic Surgery I have never seen nor heard of a single patient that I operated on or who my friends or colleagues operated on who grew mold in their breast implants. This experience covers thousands of women.

Think about it. for mold to grow it needs oxygen and nutrition (IE sugar). The vast majority fill saline implants with closed systems not open to air. Even IF a mold on the ceiling of the OR happened to enter into the STERILE salt water (IE Saline) that was injected into the implant, WHAT would this mold live on? In a short while there will NOT be a level of oxygen in the salt water that would sustain life and Saline does not contain sugar. So HOW can anything grow inside saline breast implants? If it does, it is a rare occurrence.

Sometimes notoriety is good for business.

Peter A. Aldea, MD
Memphis Plastic Surgeon

Mold in Saline Implants?

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To be honest, I have never encountered mold on or in an implant that has been removed from a patient, even ones that have been inside for over 20 years.  I am not sure how this would even happen, and I doubt the claims of women who say that they were made sick from such a thing.  This would imply that somehow they got mold into their system, or it was put into the implant itself.  Everyone uses sterile saline in the implants ( or should be), so it should not be able to grow any mold out of it or the implants themselves.  I always caution people to be careful with what they hear and/or read about diseases related to the implants.  There are so many myths out there that it can be hard to know what is real and what is not.

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.