With the Federal Drug Administration’s recent approval of Sientra – a new silicone-gel breast implant marketed in the United States by the Silimed Corp. – I thought it would be a good time to review the current status of silicone implants and their safety profile.
The modern breast implant was first introduced in the early 1960s, having been grandfathered in by the FDA. It wasn’t until the early ’90s that the safety of implants was even questioned.
Following a widely publicized discussion of the relationship between silicone implants and autoimmune problems, the FDA imposed a moratorium on the use of silicone-gel implants for cosmetic augmentation until clinical trials could be done. It’s interesting that the FDA only stopped the use of implants for cosmetic augmentation. It continued to allow their use for breast reconstruction after mastectomy.
The clear impression was that the implants were in fact safe to use (since they were allowed for patients with cancer), but that more evidence to prove that claim needed to be gathered, and controlling the use of implants would provide added impetus to gather the evidence. Also, the use of gel implants was never halted outside the United States and they continued to be commonly used for augmentation in Europe throughout the ’90s and early 2000s.
Breast implants consist of a soft silicone outer shell filled with silicone gel or saline, which is firmer and has a less natural feel than silicone gel. After extensive studies over 12 years, the FDA approved two silicone-gel implants for use in cosmetic augmentation in 2006. Since then, many women have chosen silicone-gel implants for their augmentation. According to the American Society of Plastic Surgeons National Clearinghouse of Plastic Surgery Procedural Statistics, there were 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures with implants performed in the United States in 2010. Despite the widespread acceptance and use of these devices, the FDA continues to monitor their safety and plans to study more than 40,000 silicone-gel breast implant patients.
Through the studies, most women reported high levels of satisfaction with their body image and the shape, feel and size of their implants. Answering the initial question that led to the moratorium a decade earlier, there is no apparent connection between connective tissue diseases and silicone-gel breast implants. Further, there is no evidence connecting implants with an increased risk of cancer, no effect on pregnancy or fertility and no problem with breastfeeding. Based on the totality of currently available evidence, the FDA believes that “silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when use as labeled,” and that MRI continues to be the most effective method of detecting silent (asymptomatic) rupture of silicone gel-filled breast implants.
Nevertheless, you should be aware that there can be complications in the use of implants, and that the longer the devices are implanted, the higher the chances of a complication, such as a tightening of the tissue around the implant. Rupture can occur, as can the need for the implant’s removal or replacement. Continued follow-up with both your surgeon and internist is mandatory after surgery and periodic MRIs to evaluate the integrity of the implant may also be recommended.
Most important, when you go for your regular mammogram, be sure to let the technician know if you have implants, as there are special radiological techniques that can both protect the implant and enhance the quality of the study.
Please send questions or comments to mrosenberg@plasticsurgeryweb.com. For more, log on to
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/Breastimplants/ucm259866.htm or sientra.com.
