FDA reiterates silicone breast implant safety – but urges women to follow-up for optimal health

Silicone breast implants are a safe choice -- but require follow-up attention for patient safety.

By Stuart B. Kincaid, MD, FACS

Over the last decade, plastic surgery patients and professionals have repeatedly questioned the safety risks associated with silicone breast implants; but now, in the wake of extensive research by implant producers and subsequent FDA market approval, silicone seems finally to have outgrown its ambiguous medical reputation. According to a recent report from the

American Society of Aesthetic Plastic Surgeons

(ASAPS), chief FDA scientist Dr. William Maisel conclusively reaffirmed silicone breast implant safety after a two day summit regarding accumulated study results: however, he also noted that researchers are becoming more concerned with low patient follow-up rates after receiving the implants – and stressed the importance of post-operative and annual check-ups in order to minimize complication risk and achieve optimal safety for the long term.

The ASAPS report states that two implant makers, Mentor and Allergan, enrolled 40,000 patients in long-term studies to analyze the effect of silicone breast implants on overall patient health. Over the course of the study, however, it became clear that only a small percentage of women were following through with recommended check-ups after surgery. As MSNBC reported earlier this year, Mentor accumulated three-year data from only 1 out of every 5 women involved in its study group; meanwhile, Allergan collected two-year data from only 3 out of every 5 participants. Industry experts suspect that, as patients recover completely from breast augmentation surgery and return to their normal lives, they fail to prioritize annual follow-up appointments – even in spite of surgeon instructions and FDA warnings – simply because they feel healthy.

However, because silicone implants can in some cases undergo what is known as a “silent rupture” (one in which there is no tearing or other immediate evidence), patients can suffer serious complications without realizing it until several years down the road. Ruptures and other risks to implant integrity can cause patients to experience highly avoidable health problems – most of which can be averted by complying with recommended follow-up appointments with a board certified plastic surgeon, as well as regularly-scheduled MRI screenings as recommended by the FDA.

When to opt for silicone gel implants – and how to maximize long-term health post-surgery

Silicone breast implants are a safe and versatile option for breast augmentation and revision surgeries; however, they are not for everyone, and anyone considering breast enhancement or reconstruction surgery should first consult a

certified plastic surgeon

in order to determine the best choice for their specific needs. After more than 27 years as a nationally recognized and board certified plastic surgeon, I have found silicone implants to be ideal in the following circumstances:
  • Breast enhancement surgeries for patients with small breast and/or tight breast skin looking to achieve a significant increase in bust size.
  • Procedures in which the patient is concerned about firm or wrinkled breasts.
  • Revision and replacement surgeries in which the patient has had saline implants and wishes to minimize wrinkling.
  • Revision surgeries after patients have experienced spontaneous deflation of saline implants and wish for sturdier replacement implants.

Every woman’s body is different, and no two patients can be expected to desire the same procedure – or to require identical pre and post-operative care. The need for post-operative check-ups and annual follow-up appointments is universal; but beyond that, each patient deserves customized time, dedication, compassion and complete attention to help them achieve safe, natural and healthy plastic surgery results.
At our San Diego and Temecula cosmetic plastic surgery offices, we make both FDA regulations and individual patient needs our top priority. Patients travel from throughout Southern California and Baja to experience unprecedented quality, comfort and safety throughout their procedures; and because we value our reputation as one of California’s premier plastic surgery practices, we make sure that each and every patient gets the advice, treatment and continuing care they need for optimal health. To learn more about our practice or schedule a complimentary consultation, call our San Diego office at (858) 450-4199, our Temecula office at (951) 695-9934, or visit us online: