women

Do you know what is in your breast implants?

The safety of silicone breast implants hit the headlines recently after Jean-Claude Mas, the 72-year-old founder of Poly Implant Prothese (PIP) was arrested at his home in France. He is currently being investigated for causing "involuntary harm" to women who received sub-standard implants. His company, now defunct, was believed to have sold 400 000 implants worldwide - including South Africa. While the current number of South African women affected is unknown, it is believed that as many as 15 local doctors have used PIP implants. Investigations have revealed that the implants were made from industrial standard, rather than medical standard, silicone and had a higher risk of rupturing. If the industrial silicone leaked into the surrounding tissue, it caused inflammation, pain and redness.

Description: Implants

“Prior to 1963, experimental methods of breast enlargement attempted by physicians, included injections of paraffin or liquid silicone and the insertion of sponges”

However, for those in the industry, this wasn't news. It was simply a ticking bomb waiting to explode. According to Sky News, a Los Angeles consultant plastic surgeon, Dr Grant Stevens, documented his concerns regarding PIP as far back as 2005. A case study he conducted, comparing 500 PIP implants with 500 alternative implants, found that the PIP implants were three-and-a-half times more likely to rupture than the test group. Stevens claimed that PIP asked him not to report his findings. However, in 2006, PIP received notification from their insurers accusing them of concealing complaints about the implants from surgeons and clinics. The letter claims PIP failed to notify them or French regulators of incidents which would necessitate the removal of the implants, despite it being necessary to do so. This was just one of several warnings. In March 2000, US regulators found eleven deviations from "good manufacturing practices", while in February 2009, the UK regulatory authority was warned of a number of medical claims against the company. And, a lawyer, Paul Balen, who was interviewed by Sky News, said that it was "common knowledge" in the cosmetic surgery industry that the PIP implants were inferior. According to Chris Snijman, a plastic surgeon and the national secretary of the Association of Plastic and Reconstructive Surgeons of South Africa, (APRSSA), they have identified between 11 and 15 surgeons who they believe have used PIP implants. Snijman says that PIP implants were available in South Africa between 1995 and 2009. He explains that prior to 2006, the implants had been manufactured under the European Standards and contained the CE mark. "We thought that they were okay. It was only afterwards, when reports started filtering through, that these looked like they could be fundamentally flawed and could rupture quicker than normal." The decision was then made to stop using the product in South Africa.

“Investigations have revealed that the implants were made from industrial standard, rather than medical standard, silicone”

However, there seems to be a three-year period between 2006 and 2009 when the potentially sub-standard product might have been available in South Africa.

Snijman says the silicone in PIP products are considered industrial, or second-grade silicone, rather than medical grade. "If it ruptures, it leaks and causes a local reaction. There is an inflammatory response resulting in a painful, lumpy, distorted breast that is red and inflamed. There is also a propensity for the silicone to migrate into the regional lymphatic system and, in this case, surgery will be necessary."

The problem is that the association does not know exactly how many South African women are affected by these implants. Snijman says that some of their members may be a little embarrassed to admit that they chose a cheaper option, which is causing a bit of a panic. "We suspect that one surgeon has implanted around 300 pairs of PIP implants."

And, because the original supplier is now defunct, there is no recourse for the surgeon. "We recommend that our members contact all their patients who have PIP implants and request them to come in for a clinical examination. Should the implants have ruptured, the solution is easy - the implants have to come out. We have recommended that our members negotiate with their patients, to preserve their good name and show that they are not in this for the money." Snijman suggests that surgeons don't charge for the procedure, and try to negotiate with the hospital group they work with, as well as negotiate a fee on the replacement implants.

However, he says, doctors are faced with an ethical dilemma. If the PIP implants don't show signs of rupture - do you take them out, or do you just sit and watch? "This is a difficult situation - it's like sitting on a time bomb," he cautions.

“We have recommended that our members negotiate with their patients, to preserve their good name and show that they are not in this for the money”

A letter, drafted by the Association of Plastic and Reconstructive Surgeons of South Africa to its members on 16 of January, adds that in the absence of clinical symptoms of rupture, patients should not be advised to remove the implants, but should rather have regular follow up examinations and yearly sonar appraisals. However, as Snijman said, should there be the presence of clinical symptoms of possible rupture, there should be confirmation of this by an ultrasonographicappraisal of the implants. In the case of rupture, the implants will need to be removed, and the patient given the option of reimplantation, removal alone, or removal with "mastopexy in the scenario or redundant skin and ptosis [droopiness] post explantation."

Doctors are faced with an ethical dilemma. If the PIP implants don't show signs of rupture-do you take them out or do you just sit and watch?'

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