by Aralena Malone-Leroy
In late December 2011, while most Europeans were doing last-minute holiday shopping and preparing for gargantuan meals and family festivities, hundreds of thousands of women spent achingly sleepless nights, worried that their breast implants might be giving them cancer. The French Ministry of Health had just released a statement recommending that women with breast implants manufactured by the French company Poly Implant Prothèse (PIP) have them removed, even in the absence of signs of rupture or other complications. All medical fees for the “preventive” process would be covered by national health resources.
This announcement, which concerns more than 450,000 women worldwide – approximately 30,000 in France and 40,000 in the United Kingdom alone, with thousands more in Spain and Italy, as well as Brazil, Bolivia, Colombia, Argentina, Ecuador, and Venezuela – came nearly 12 years after the first alarm sounded on the substandard quality of the PIP breast implants.
In early 2000, the U.S. Food and Drug Administration sent a damning report to the PIP factory. The “low-cost” implants contained industrial-grade silicone (including such chemicals as Baysilone, a fuel additive, and Silopren and Rhodorsil, used in rubber manufacturing) instead of the required medical-grade silicone. The rupture rate of the PIP implants was dangerously high, over 1 in 10. PIP stopped selling the unsafe implants to the United States, but they remained impervious to the health risk of their faulty products and continued to market the low-cost implants elsewhere. It was not until April 2010 that PIP was shut down by the French government and the implants definitively removed from the French and international markets.
Why it took nearly 10 years for French authorities to finally remove PIP silicone implants from the market is one that the government will attempt to answer over the next few months. Xavier Bertrand, Minister of Labour, Employment, and Health, has ordered France’s two main regulatory agencies for drugs and medical products to disclose the tests and controls that allowed toxic silicone implants to be sold.
Twenty cases of cancer have been reported in French women with the PIP implants. One woman passed away due to lymphoma. While official statements continue to deny any direct link with the implants and cancer, the dangerous rates of rupture and inflammation caused by leakage of the industrial-grade silicone is proven and condemned by the government.
Italy, the Czech Republic, and Germany have all released official recommendations that women with PIP implants have them removed. But not all health officials are recommending removal. While suggesting that patients schedule appointments with their surgeons to have the implants checked for leaks or ruptures, health department statements from Britain, Israel, and Venezuela deny any urgency for removal. Other governments suggest that clinics have a “moral duty” to remove the implants for free, if necessary.
The ambiguity of these differing government stances is confusing at best, criminal at worst. In Iceland, Saga Ýrr Jónsdóttir, a lawyer representing women with PIP implants, decried her government’s refusal to pay for the removal of non-leaking implants, saying that, “It’s like telling you that you have a ticking time bomb inside you but that it won’t be removed until it has exploded.”
Much of the scandal surrounding the PIP implants is about whether or not national health plans should cover the costs of removal. Most agree that women given PIP implants for reconstructive surgery after a mastectomy are entitled to financial compensation to have those implants removed. Women who underwent elective cosmetic surgery, however, are regarded less as victims and more as losers in a crap-shoot. Commentators declare that they chose to have the unnecessary plastic put in and should suffer the consequences.
There are undeniable risks associated with cosmetic surgery, particularly with breast implants. Post-operative infections, chronic breast pain, nipple numbness, and rupture and leakage of the implant, are a few of the documented known risks.
As the PIP story unfolds, however, the gross negligence exhibited by the French government in failing to protect women from a toxic product cannot be minimized. Anyone considering getting breast implants is responsible for informing herself of the complications that can and do arise. But in France, the consensus remains that it is the role of the government to guarantee the safety of approved medical devices and procedures. It is the responsibility of doctors to remain vigilant about the potentially life-threatening risks that low-cost medical products pose.
In Britain, the Association of Breast Surgery, the British Association of Plastic, Reconstructive, and Aesthetic Surgeons, the British Association of Aesthetic Plastic Surgeons, the Federation of Surgical Specialty Associations and the Royal College of Surgeons released a joint response that makes the obvious clear: “This situation raises again the need for better regulation and surveillance for all surgical implants, and the surgical profession believes mandatory databases should be the next step – not least because this issue has exposed poor record-keeping.”
Cosmetic surgery is a frightening hallmark of our times. While literally hundreds of thousands of women’s lives are in potential danger due to PIP’s knowingly dangerous manufacturing practices, how many more women and men are also risking their lives to sculpt their given bodies into ones dictated as attractive by society, Hollywood, and fashion magazines? Botox, liposuction, face-lifts, collagen injections, and breast lifts have all become commonplace procedures. Does it take a PIP scandal to wake us up to the dangers of cosmetic surgery?
Aralena Malone-Leroy earned her Bachelor of Arts degree in French and international studies from Santa Clara University, and a master's degree in mass communications and journalism from San Jose State University. Aralena lives in France and is the news editor for The WIP.