Notice: This article was written in 2006 and might be outdated. It is not medical advice, does not endorse recommend/not recommend any product, nor recommend/not recommend any procedure.
FDA Approves Sale of Silicone Implants to Applause and Criticism
The Food and Drug Administration (FDA) approved the sale of silicone breast implants on Friday. This type of implant, but not the saline ones, had been banned for sale in the U.S. since 1992. The New York Times reported yesterday that "supporters" of the FDA decision, "including leading surgeons, applauded" this week's approval of silicone breast implants. Others apparently "lambasted" the decision. The products are manufactured by Allergan Corp. (formerly Inamed), and Mentor Corp., both in California. The FDA reviewed clinical trial data from the two manufacturers for "up to four years", and studied "a wealth of other information to determine the benefits and risks of these products", according to Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.
Risks
Women who contemplate the operation to have implants inserted will most likely come across marketing data from the implant makers and plastic surgeons. However there are real risks to the implants, described in the 44 pages of consumer information on Mentor's product, in "Important Information for Augmentation Patients About Mentor MemoryGelTM Silicone Gel-Filled Breast Implants"--available here. (This is a separate document from the breast reconstruction document for Mentor, and also separate from Allergan's augmentation and reconstruction documents). The most common risk is re-operation. According to Mentor's data 15.4% of primary augmentation group and 28% of the revision-augmentation patients were reoperated during the three years of the study. For the Mentor reconstruction group, those numbers were 27% and 29%. For the Allergan augmentation group, studied over 4 years, those numbers were 23.5" and 35%. For the Allergan reconstruction group over 4 years 41% and 33% of patients were reoperated.
Rupture is another risk. Rupture is often silent (unnoticed by the wearer) therefore most reliably detected with regular Magnetic Resonance Imaging (MRI) examinations, which the FDA recommends after 3 years and once every 2 years after that. Unfortunately, compression during mammographic imaging increases the risk of rupture. In the Mentor Core Study the rupture rate was 7.7% over 3 years for the MRI cohort¹.
When the breasts rupture, the silicone gel can "remain within the scar tissue capsule surrounding the implant", or it may migrate, which has possible health consequences. The report summarizes the health consequences, "which have not been fully established", but include change in breast shape or size, pain, and "rare" reports of nerve damage, granuloma formation, tissue breakdown, and lymphadenopathy due to migration of the gel into the liver, arm, groin, chest wall, armpit or upper abdominal wall. A study released in April, 2005 in the study, published in the American Journal of Surgical Pathology, reported on the pathology of lymph node biopsies of women 96 who had breast implants removed and 14 controls. Rare foamy macrophages were found in 91 implant women and 4 controls. Refractile studies showed the presence of polyurethane in 16 women, and silicone in 86 women. Spectroscopy confirmed the presence of silicone in 71 patients with implants, and the presence of 2 polyurethane in 2 patients with implants. Silicone and polyurethane were not found in the control group's lymph nodes.
Capsular contracture is separate side effect, classified by Baker Grades which help physicians determine the severity of the side effect that can necessitate removal. The implants usually aren't removed in cases of Baker Grades I and II, however in Baker Grade III, where the breast hardens and changes shape, and Baker Grade IV that involves "hard, obvious distortion, and tenderness with pain", the implants usually need to be changed. The two company's clinical trials showed slightly different results for side effects. In the Mentor study 8% of the women who received first time augmentation experienced severe capsular contracture in the first three years. In the revision-augmentation cohort the risk was 19% in three years. Nipple complications and scarring/hypertrophic scarring occurred in approximately 10% and 8% of the population, respectively. Other complications occurred much less frequently, such as sagging, lactation complications, infection, hematoma, etc.
The studies also followed self-reported signs and symptoms of which there were 100. There were 50 reports of rheumatological symtoms and a few other frequently reported conditions that were not necessarily caused by the implants including:
"significant increases...[in] fatigue, exhaustion, joint swelling, joint pain, numbness of hands, frequent muscle cramps and the combined categories of fatigue, pain and fibromyalgia-like symptoms in primary augmentation patients, and for joint pain in revision-augmentation patients. These increases were not found to be related to simply getting older over time.
The FDA decision also requires the two companies to follow 40,000 women who receive breast implants for 10 years. The patient information listed on the FDA site notes that the breast implants are not permanent, and need to be periodically replaced. The older they are the more likely they will need to be replaced.
High Patient Satisfaction
According to Mentor's own survey on patient satisfaction, when asked by their surgeon at 3 years: "Would the patient have this breast surgery again? 81% of the 146 revision-augmentation patents, and 83% of the 456 primary augmentation patients answered. Of those, Mentor said, 94% and 98% respectively, said they would.
Acronym Required wrote about silicone implants last year in Silicone Implants -- A Health Risk to Choose?, which looked at documents obtained by the New York Times showing that ruptures probably more common than Mentor reported and that the company falsified data. In "Silicone Implants and the FDA (more)", Acronym Required looked at different opinions about why the FDA had at one point approved Mentor's application, but not Inamed's. The NYT had reported that Mentor may have falsified data. In addition, the Boston Globe reported that there were different numbers of plastic surgeons on the review committees for each company.
Some Disapprove
Some think the decision is a travesty. The National Organization for Women, (NOW), said, "sadly, we are not shocked that this agency is swayed more by money and politics than science and medicine." Among other health issues, NOW expressed concern for the health of the women and children, and especially evidence that platinum leaks from the silicone implants. Research on this issue was published in Analytical Chemistry. Acronym Required wrote about this several months ago in "Platinum Bonds and Silicone Implants". Plastic surgeons are elated by the news. "For us, it's a triumph of science," said Dr. Richard A. D'Amico of Engelwood, N.J., who is president-elect of the American Society of Plastic Surgeons.
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¹ This consumer information said that the non-MRI cohort had "0%" rupture rate, however elsewhere the report makes it clear that silent ruptures can only be detected by MRI. The presentation of information was confusing -- it's not "0"- it's unknown. As well, will the juxtaposition of the data discourage women from getting MRI's, even though the FDA recommends them?
