PIP Breast Implants

This morning there was an article in the Melbourne press reporting about the concern for many woman around the world who have had PIP silicone breast implants inserted. There are believed to be 30,000 women in France with PIP silicone breast implants and perhaps a total of 300,000 around the world.

It is known that these PIP silicone breast implants have been filled with an industrial grade silicone rather than a medical grade silicone. This means that the chemicals inside the silicone act in a way to dissolve the outer shell such that the implant usually bursts and deteriorates within 2 years. The result of these implants bursting is often the formation of silicone granulomata (lumps of silicone) in the breast tissue, in the lymph glands and in other parts of the body.

Until now, the advice given by the various plastic surgery societies has been for women “not to panic” but to visit their GP or surgeon.  It seems that this advice is now slowly changing and it would appear imminent that women with the PIP silicone gel implants will be advised to have these implants removed. At the very least a scan will need to be done to determine whether the implants are intact or whether they have ruptured.

I have never used the PIP implants in my practice at Avenue Aesthetic Surgery and therefore none of our patients need to be concerned. I have, however, had firsthand experience of removing a ruptured PIP implant. The silicone had lost all of its cohesivity and had become a slimy yellow fluid which was difficult to remove in its entirety.

Having seen the effects on the surrounding tissues of a ruptured PIP implant, I would unreservedly recommend that any woman with a PIP silicone gel implant give serious consideration to having the implant removed. It could be that some of the earlier PIP implants were made with a correct medical grade silicone. After all, the implants were approved by our own Therapeutic Goods Association (TGA) who are responsible for certifying and approving these products for supply in Australia. It is possible the manufacturer provided the TGA with an original and appropriately manufactured implant while some time later changing their manufacturing process to incorporate the use of industrial grade silicone.

A second and separate matter recently bought to the attention of consumers is the development of a very rare type of cancer in the capsule surrounding breast implants. This cancer is known as Anaplastic Large Cell Lymphoma (ALCL). It extremely rare having been detected in only 80 patients worldwide. Unfortunately we have had a few cases in Australia and one of the women concerned has developed metastatic disease (in other words the cancer has spread beyond the breast).

Although it is not completely clear what causes these cancers, they would appear to be associated only with textured breast implants.  Further, there are a number of ways of producing texture on the surface of the implants and it would appear that the ALCL cancers are associated only with implants that receive their texturing by the spray-on application of salt.

Patients at my practice need not be concerned as I use only smooth-walled implants.

If you have had a textured breast implant inserted then it is worthwhile finding out which brand of implant you have and how the texturing was produced. Should the texturing had been produced with salt crystals then it would appear that you have a definite, but low risk of developing ALCL. How this risk is managed is up to you and your surgeon. Many women would elect to have their implants replaced with smooth-walled implants. An alternative management plan would be to regularly scan your breasts searching for any excess fluid around the implants or any irregularity in the fibrous capsule.

I reprint here in full the article recently published in the Melbourne Age.

Doctors urge implant register

Julia Medew

December 22, 2011

AUSTRALIAN plastic surgeons are encouraging women with breast implants to sign up to a national register amid fears all implants may be linked to a rare form of cancer.

There is also concern about a high rupture rate for one implant called a Poly Implant Prosthese or PIP, which has been recalled worldwide after overseas health authorities found some contained industrial silicone instead of medical silicone.

While the French government is reportedly considering an order for the PIP implants to be removed from about 30,000 French women, and British doctors said people should have them removed for ”peace of mind”, the Australian Society of Plastic Surgeons said it did not believe there was a need for the estimated 4500 Australian women with the same implants to panic and follow suit.

Society spokesman Graham Sellars said if women were concerned about their implants, they should talk to their surgeon or GP about it.

He said women with implants should also consider adding their details to a national breast implant register as doctors try to ascertain if there is a link between all implants and a rare form of cancer called anaplastic large cell lymphoma or ALCL.

He said about 80 cases of the cancer in women with implants had been reported worldwide, including seven in Australia.

In many cases, the cancer was found in scar tissue around implants after women complained of pain in their breasts. The implants in those affected included both saline and silicone varieties. ALCL is estimated to affect about 1 in 500,000 women each year.

In a statement about the possible link this year, the US Food and Drug Administration said it did not believe the risk was high enough to recommend implant removals as a protective measure.

”The FDA believes that women with breast implants may have an increased risk of developing ALCL, but also believes any potential risk is extremely low.

”Due to the rarity of ALCL, the small number of reports, and the incomplete and limited data from these reports, more information is needed to fully understand the possible link between breast implants and ALCL,” the statement said.

Dr. Sellars said that given an estimated 5 million to 10 million women had had implants globally, women should not panic about the risk, but rather talk to their doctors about it and if necessary, have their implants checked. If an implant ruptured, he said it could cause breast tissue to become lumpy and deformed, but he said there was no evidence to suggest a rupture would cause cancer.

A spokeswoman for Australia’s watchdog, the Therapeutic Goods Administration, said tests on PIP implants in Australia had previously found them to comply with regulations. She said there had been 45 reports of problems with them, including 39 ruptures.

She said there had been no cases of ALCL in women with the PIP implants in Australia and urged anyone with concerns to consult their treating surgeon for advice.

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