9 January 2012. A World to Win News Service. A breast implant scandal threatens some 300,000-400,000 women worldwide with the possibility of industrial-grade silicone gel leaking into their bodies like melted butter.
With zero remorse, Jean-Pierre Mas, the owner of the Poly Implant Prothese (PIP) company located in southern France, formerly the world's number three implant manufacturer, readily admitted that it used this substandard material in 75 percent of its implants to maximize profit – after all, that is what companies have to do to stay competitive. He has accused his victims of being emotionally unstable women trying to make money from him.
Now it has been disclosed that to save money PIP also stopped including a inner protective layer around the implants. The industrial gel can leak into a women's body even if the implant doesn't actually rupture.
Equally hideous, the full extent of possible risks to women from the faulty gel is unknown because government health agencies in the countries concerned have not been keeping records of problem cases.
The implants were not pulled off the market a decade of alarms. PIP had been making about 100,000 a year, for sale in 65 countries world wide, mainly in Europe (France, Germany, Italy, UK, Portugal, Denmark, Poland, Holland, Bulgaria, Malta) and Latin America (Argentina, Brazil, Colombia, Venezuela), which is where the highest number of women with implants live.
Despite the increasing knowledge of leakage danger, the PIP implants were sold to a Dutch company called Rofil and marketed as "M-Implants" to escape the growing shadow on the PIP brand. They were sold under the new name in Eastern Europe and the US, where PIP implants had been banned.
When PIP started producing the silicone breast implements in 1991, they were approved by a German health agency. As early as 1993, seeking greater profits, the company secretly switched from the approved silicone and began producing its own formula containing fuel additives and material used for rubber tubing. Since regulatory agency inspections were made known in advance, PIP could hide any evidence of using substandard material. This was true also when France, after overturning a 10-year ban on silicone implants, inspected the company in the early 2000s, and subsequently also approved the PIP breast implants.
The technical director of PIP, Thierry Brinon, explained that in 2009, the industrial gel cost his company only $6.50 a litre, whereas the approved silicone cost $45. The changeover meant a million and a quarter dollars extra profit for every 100,000 implants. (Telegraph, 6 January 2012)
Clinics in various countries that performed the breast implant surgery also benefited from the cheap PIP product, which they bought without lowering prices to their patients.
Many warnings of danger surfaced throughout the 2000s. Surgeons doing the implants were becoming anxious when they began noticing that some patients' implants were rupturing and leaking silicon, although it now seems that the true extent of the problem remained unknown because cases of leakage remained undetected, and because the women's health complaints were often ignored.
In 2000, after inspecting the PIP plant, the US Federal Drug Administration (FDA) issued a statement reporting that the implants did not meet American health requirements. An open question is to what degree the motivation for this was to keep a competitive edge for US pharmaceutical companies against their French counterparts. Another factor may have been a spate of US lawsuits in the 1990s about silicone implants made by PIP and Dow Corning, also the manufacturer of napalm. This made the whole American cosmetic surgery industry nervous and put some demands for stricter regulation on the health authorities.
The French regulatory agency, which failed to take action all those years, now claims that it was unaware that the FDA had banned PIP implants in the U.S., although national health agencies routinely share information. The pharmaceutical industry is a particularly important core part of French capital and has long enjoyed unabashed government protection, especially against the competition in other countries.
At any rate, in recent years lawsuits against PIP began eating into company's profits. In an effort to solve leakage, another substandard gel was produced by the company. After repeated letters by the head of a plastic surgery clinic in Marseille to the French health watchdog agency, inspectors paid a surprise visit to PIP in February 2010 and established that its records had been falsified. Shortly after, the French government closed the company down.
Since then the scandal has continued to mount. So far the French health safety agency has registered 1,143 ruptures and 495 inflammatory reactions from the implants, out of a total of 30,000 women who received PIP implants in that country.
The behind-the-scenes debate smouldering over the past years was reignited in France when a woman who had PIP implants died from a rare breast lymphoma in November 2010. There are 20 reported cases of women in France who have the PIP implants and also have cancer, although no connection has been established.
The biggest health concern right now is whether silicone leakage may trigger an auto-immune reaction by the body's own natural defence mechanisms. Such a reaction means that a sort of civil war occurs within the body that can produce profound weakness, fatigue and pain, along with damage to the joints, skin, connective tissue and internal organs.
Last December the Associated Press reported the case of Emmanuelle Maria from the same town where PIP was based. As an adolescent she had a bone disease which left her disfigured and had breast implants in 2007. In early 2010 her breasts felt like they were burning and globules of silicone gel were protruding into her armpits. Yet her doctor told her nothing was wrong. She went to two other doctors, who finally confirmed both implants had burst.
Even when an implant ruptures it may go undetected because the silicone may remain "cohesive" and not leak into the breast tissue. The PIP implants, however, are not only more likely to rupture, but the industrial grade silicone is more difficult to extract because it lacks this "cohesion". A French surgeon from Paris' Saint Louis Hospital commented that a rupture could leak internally, requiring surgery in other parts of the body and ''once these implants are removed, the story is not over... we don't know the consequences.'' (Boston Globe, 22 December 2011)
The extent and seriousness of the problem are not clear because the medical authorities have not been paying attention. In most countries cosmetic surgery is not submitted to the same close observation and record-keeping as other surgical procedures and pharmaceuticals. The reporting of problems is often done on a voluntary basis.
The lack of reliable data is itself an indication of official indifference to women's health. The French health authorities now estimate that 5.5 percent of PIP implants have ruptured. Transform, Britain's largest cosmetic surgery chain, reported a leakage rate of 7 percent for PIP implants. One of the members of the UK government-commissioned panel investigating the scandal, the head of the British Association of Aesthetic Plastic Surgeons, said it was "quite possible" that the true rupture rate was in double digits.
Not even the rupture rate of all the implants on the market is known with certainty. While UK government health officials reported less than 1 percent rupture in general, a study conducted in 2005 found an 11 per cent rupture rate after 13 years. (Independent, 1 January 2012)
Reactions by various governmental health regulatory agencies and health ministers from many of the countries involved have varied, but some common features in their approach are apparent. All insist there is no danger of causing cancer (which studies about breast implants in general so far seem to confirm) and that there is no reason for women to panic.
Since cancer is not the only risk, this only adds insult to the potential injuries women have every right to be concerned about. France's health ministry has acknowledged that there is a "well-established risk" of rupture. In France, Germany and Venezuela, governments have recommended implant removal while the authorities in most of the other countries have said that there is no need to do so except when there is an actual rupture.
In the UK, where the breast implant industry is worth over $150 million (100 million pounds) annually, with 20,000 to 25,000 women every year having the surgery at a cost of $6,000 to $9,000 (4,000 to 5,000 pounds) each, successive governments ignored reported ruptures as well as other alarms about PIP implants going back at least to 2005.
The initial UK government reaction was to downplay the need for what it considered unnecessary expenditures as it cuts back sharply on the National Health Service. Instead of focusing on concern for the 40,000 British women who have the potentially dangerous PIP implants, the official debate is centring on cost and who is going to pay.
At first the UK Health Ministry refused to recommend that all PIP implants be removed and replaced. It took the position that this was necessary only if a rupture was found. Nigel Mercer, the previous president of the British Association of Aesthetic Plastic Surgeons, was unequivocal in disagreeing with this approach. His advice was for all PIP implants to be removed. "This silicone can cause intense fibrosis [thickening of tissue]. You have to ask yourself what would you recommend a family member to do. I would not want them to keep the implants in. You are sitting on a time bomb." (Independent, 2 January 2012)
Over the last few days, with mounting outrage and as various surgeons denounce the lax attitudes by all involved, the health ministry agreed to allow the National Health Service to remove and replace the implants of the 3,000 women who received the implants from NHS if they and their doctors insist. But it refused to issue a blanket directive for all such women. Minister Andrew Lansley confined himself to saying that private clinics have a "moral duty" to remove the implants, leaving them legally free to refuse.
That is in fact what they have been doing. Private clinics have been unwilling to deal with the expense of testing their former patients or even talk to them in some cases, let alone bear the cost of new operations. They argue that they should not be held responsible for buying products freely available on the market when the authorities never indicated any potential problem. Bent on privatizing much of healthcare, the British government is in no position to force private clinics to operate unprofitably or close.
Since the scandal first broke out the dominant official view regarding breast implants has been disdainful of the women who have them. It is often said that cosmetic surgery is a question of a woman's "vanity''. As an association of French women endangered by the PIP implants points out, they are twice victimized, once by having the faulty implants and now by being considered "bimbos" (brainless big-breasted would-be sexpots) as a result.
The subtext is that it serves these women right if their implants prove dangerous. Such views are probably a factor in why there is such a lack of follow-up on "cosmetic" procedures that are overwhelmingly performed on women, even though the dangers are as real as in any other type of surgery.
Is is also true that there is a general lack of clinical trials regarding new substances used for implantable devices to understand their long term and potential harmful effects.
The reasons for women wanting breast implants vary widely. Often it is because of disfigurement, most commonly due to breast cancer surgery. But mainly that is not the case.
Encouraging women to have them, the cosmetic surgery industry says that the answer to the low self-esteem many women feel is to enlarge their breasts. Websites touting breast augmentation services often argue that the most important reason to have the procedure is because it enables many women to feel better about themselves. But why would having bigger breasts make women feel better about themselves unless that were essential to the way they are valued? This says a great deal about women's real status. This lack of self-esteem cannot be separated from the oppression of women as sexual commodities and lesser beings in all spheres in society.
Many of those afflicted with the PIP implants are very young. In Venezuela, some people consider a breast implant operation to be the ultimate birthday present for a girl on the occasion of her fifteenth birthday (quinceanera). The fifteenth birthday is considered a rite of passage for these young girls. This, too, is a signal to them about what their future as women holds.
The cosmetic surgery industry, the authorities and other people often argue that breast augmentation is simply a matter of a woman's "choice". This ignores the fact that women are imprisoned in a patriarchal society that largely determines what their choices are. Rather than blame women for a lack of self-esteem, this should be recognized as an internalization of real-world social relations that cannot be changed without changing the way society is ruled and organized.
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