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PIP Implants Update

Thursday, January 5, 2012

During the last week we have received many calls from patients requesting confirmation that they do not have breast implants manufactured by the French company Poly Implants Prostheses (or PIP). All of our patients can rest assured that we have never used PIP implants in this practice – furthermore the vast majority of our patients have accepted our advice to have saline-filled implants inserted.  One of the major advantages of saline implants is that leakage is easily detected as the breast quickly diminishes in size.

Fortunately, this is very rare occurrence but, never the less, it is reassuring to know that if your saline implant ever were to leak, that it only leaks salty water which is absorbed by the tissues.  You never need to have an x-ray to determine whether your implant is leaking so there is really no need to worry. Patients with any form of silicone implant, however, can never enjoy the same level of peace of mind. One of the problems with silicone implants, and especially the high cohesive gel silicone implants, is that any rupture is not easily detectable. The silicone that leaks out of these implants initially stays in place within the fibrous scar tissue capsule that the body makes around any implant. Often there is no pain associated with rupture of a silicone-gel implant and the breasts often feel the same. Often, the only way to know whether a silicone breast implant has ruptured is to do an MRI examination. The problem with having an undiagnosed ruptured silicone-gel implant is that there is a risk that the silicone-gel will spread into the tissues around the breast and elsewhere.

Often the first sign of a ruptured silicone-gel implant is a lump appearing under the arm. This is a silicone granuloma and its removal will necessitate a separate incision (and therefore a scar) under the arm.

Often the silicone granulomata are not solitary and, therefore, when the silicone implant is removed, multiple silicone granulomata are found. It is often not feasible to remove all of these silicone granulomata without causing a lot of damage to the breast and surrounding tissues.

The specific problem with the PIP implants is that they have been filled with an industrial grade of silicone (rather than an approved medical grade) containing a number of chemicals. This type of silicone was never designed for implantation into the human body as it quickly dissolves the shell of the implant and liquefies. I had the experience of treating a patient who had PIP implants inserted in Darwin 2 years previously.  The first time she noticed something wrong was when she developed a lump under her right armpit. Radiological examination showed that both implants had in fact ruptured. At operation liquefied silicone was found in both breasts with multiple silicone granulomata – some the size of golf balls.  This had occurred only 2 years after her original operation!

The current situation is that approximately 300,000 women in 65 countries have had PIP implants inserted. We don’t know how many of these implants were filled with the inappropriate type of silicone. In France the health authorities have recommended that the 30,000 French women with PIP implants have the implants removed. By contrast, in Australia, our own Therapeutic Goods Administration (TGA), which regulates the sale of medical devices, has attempted to reassure women saying that there is no evidence of an increased rupture rate of PIP implants. The problem is that not all cases of ruptured PIP implants have been reported to the TGA.  In addition, the TGA must be unaware of PIP implants that have ruptured but have not yet been removed.

In the United States, PIP implants have never been approved for use.  Their regulatory body (the FDA) currently has a requirement that all women with silicone breast implants have an MRI every 2 years as this is the only way to ascertain whether or not the implant has ruptured.

Because of the risks associated with the rupture of silicone-gel breast implants (the formation of silicone granulomata), because most ruptures occur without any symptoms or signs in the early stages and because of our knowledge that PIP implants may contain a gel which is not approved for medical use, it would seem to be prudent that all women with PIP implants should have an MRI examination in order to determine whether or not their implants have ruptured. If the implants are shown to have ruptured then they should be removed. If the implants have not, as yet, ruptured then a decision has to be made as to whether they should be removed or followed closely by regular MRI examinations at least every 2 years.

PIP breast implants have never been used at Avenue Plastic Surgery.

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