Our State of The Art Facility
We trust our patients deserve a clean and professional environment to achieve a great plastic surgery experience.
PIP IMPLANT COMPLICATION FACTS: What you need to know
At Christopher Craft Cosmetic Surgery, patient care is very important to us, and we are continuously striving to inform our patients about healthy and knowledgeable decision making when it comes to their cosmetic needs. With the recent scare of Poly Implant Prothese (PIP )implants from France, it is important that our patients, new and existing, understand the answers to some of the questions many clients are asking.
Concerns about the safety of the PIP implants were first raised in France when surgeons noticed they were rupturing more easily than other brands. It was the death of a French woman from cancer last year that had the implants that caused a global health scare for many around the world. According to The Daily Mail sixteen cases of cancer have since been linked to the implants. The PIP implants, made by French company, contain industrial grade silicone, what is used in the manufacture of mattresses instead of specialist medical material, and it is thought that many of the implants were missing a protective coating designed to keep them from rupturing and preventing any silicone solution that could leak from spreading through the body. Although the implants are French, PIP implants were the third largest implant company in the world, distributing to over 65 countries. Approximately 300,000 implants were exported mainly to South America (in particular Venezuela, Brazil, Colombia, Bolivia, Chile and Argentina ) but also China, Iran, Turkey, the United Arab Emirates, Israel, Holland, Germany, Italy, Portugal, Denmark, Spain, Britain, and Australia. PIP saline-filled implants were available in the United States with approximately 35,000 PIP saline implants implanted by that time. However, PIP did not sell its silicone implants in the United States at the time because such implants were subject to a general ban due to safety concerns raised by the FDA based on its observations upon inspection of the PIP plant at La Seyne sur Mer, in south-east France. The authorization for use was revoked after a re-evaluation by the Food and Drug Administration in 2000 found 11 deviations from 'good manufacturing practices including the company's failure to investigate the deflation of its saline implants and a failure to report more than 120 complaints in France and elsewhere to the FDA. PIP closed its business in 2010following widespread accusations of potentially unsafe medical practices in the manufacture of its implants.
At Christopher Craft Cosmetic Surgery, we urge patients to become informed about their health needs If you have any questions about your implants, refer to your implant ID card, provided to you by your surgeon after your date of surgery, or call your surgeon for more information. It is reported in Holland, that over 1,000 women received PIP implants sold under a different name, and rebranded as M-Implants. In China, PIP implants named Bao Libei in Chinese have been used for some time. In Venezuela, 84% of implants come from French companies, however the number of those with PIP implants has not been officially announced.
According to BBC News, Tara Smith, 40, from Newark, had the Poly Implant Prothese (PIP) implants in 2006 and recounts having five operations since the implants, infections and illnesses due to the PIP's, causing her much pain and inflammation.
In Germany, the Federal Office for Pharmaceuticals and Medical Devices said investigations shown that even implants which did not show signs of rupturing could pose a health risk, and many governments throughout the world are urging patients that have PIP implants, to see their surgeons for a regular checkup. Other countries like France, Germany, Venezuela, and Bolivia urge women who have the PIP implants implanted to have them removed.
At Christopher Craft Cosmetic Surgery, your health care needs are paramount in our practice. We want you to feel comfortable about asking questions and seeing your surgeon in follow-up care. We use FDA approved saline and silicone implants from Mentor and Allergan. If you have any questions, please contact us for free information at 305-596-9700, or come in for your free consultation with Board Certified Plastic Surgeon, Christopher M. Craft, MD. In order to be of service to assist those patients who had the PIP implants placed, we are offering implant exchange for FDA approved implants and removal of the implants at a reduced rate. Please call or come for consult for further information.
We will continue to diligently monitor the reports and findings in effort to provide the most up to date information concerning these potentially harmful implants.
More data is slowly coming available concerning the PIP implants as time goes on; I will try to continue to providea summary of this information as it is available.
The best course of action regarding PIP has changed slightly over the past weeks. The National Health Service from England (similar to their FDA) has stated that there is no increased risk of cancer associated with the PIP implants. The NHS has however confirmed that the silicone used in the implants is indeed industrial grade and not the more refined medical grade used in the FDA approved implants available in the USA.
The rupture rate with the PIP implants has been one of the greater concerns with the implants and has been estimated to be nearly as high as double the rate of those used in the US. The concern being if the implant were to rupture the industrial grade silicone would then be exposed. The risks associated with this would include capsular contracture, foreign body reaction, granuloma formation, migration of the silicone through the body, and the very rare immune system cancer Anaplastic Large Cell Lymphoma. The incidence of this cancer is higher with the implant based exposure but remains quite rare with an incidence of 1 per 500,000 women. Symptoms associated with this disease are nonspecific and include breast pain, heat, redness, inflammation, and fluid accumulation. The cancer is not known to metastasize and is cured with simple excision.
Based on what I am reading my current recommendation is that removal is not an emergency but due to the increased rupture rate and associated problems I recommend removal or replacement when convenient simply for a decreased complication rate and for peace of mind.