When the Federal Drug Administration lifted a ban on silicone breast implants in late 2006, surgeons like Dr. Ben Lee saw an incremental increase in the number of patients seeking breast implants. The reason: silicone implants are more pliable, naturally feeling and looking than saline implants that are not malleable like real breast tissue.
Once the announcement of silicone approval was made public, the FDA also attached a requirement that surgeons qualify to perform the silicone implant procedure by passing an online course over 90 days. That put the first silicone implant surgery three months out. Patients who had been “on the fence” about implants scheduled their breast augmentation surgeries and “the phone was ringing off the hook,” says Dr. Lee, a double-board certified plastic surgeon practicing in Englewood, Colorado, a suburb of Denver.
Prior to the FDA’s endorsement, silicone implants were limited to reconstructive surgery for post-mammogram patients, so Dr. Lee, who is highly regarded for his reconstructive surgery as well as breast enhancement surgery, was already familiar with silicone implants. He immediately underwent the training and is now performing the surgery for patients who’ve been anxiously awaiting their scheduled surgeries.
Even though silicone is a higher priced implant over saline, it’s not stopping patients from choosing the “real” look and feel over saline implants that are too perky for most women’s preference. Silicone implants run approximately $800/pair (materials cost to the surgeon) vs. $350/pair for saline.
The differences between Saline and Silicone run much deeper than cost and feel. Silicone implants are less painful by far, says Dr. Lee, and they require less recovery time because they are implanted on top of the muscle tissue rather than underneath it like Saline implants. Silicone is also, according to Dr. Lee, the optimum type of implant for women without a whole lot of breast tissue, something most women seeking implants don’t have naturally. “The two things people worry about are downtime and cost,” the Doctor says.
Implants run about $6500 and about $8000 with a lift in Dr. Lee’s practice.
Silicone breast implants are possibly the most extensively studied implant in existence, even according to FDA spokesmen. Over a more than 10-year period, independent studies examined whether silicone gel-filled breast implants were associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, that doesn’t mean the studies will stop. Post-FDA-approval studies are continuing with the FDA monitoring makers of the implants—Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.—following 40,000 women for 10 years.
Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, for the FDA, was quoted in the FDA News in November 2006 as saying, “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.”
The full disclosure that the FDA spokesperson refers to is in the package and patient labeling on the implants required by the FDA. Risks and benefits highlighted in this literature include:
- Breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime
- Many of the changes to a woman’s breast following implantation are irreversible
- Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured
- A woman will need regular screening MRI examinations over her lifetime to determine if silent rupture has occurred, the first three years after her initial implant and then every two years thereafter.
- If implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.
Patients who have had an MRI for any reason are familiar with the cost of that procedure, approximately $2000. That means that over the lifetime of one’s implants the MRI testing will exceed the cost of the original implant surgery.
Post-approval studies will collect information on the safety and effectiveness of the implants, including:
- rates of local complications
- rates of connective tissue disease and its signs and symptoms
- rates of neurological disease and its signs and symptoms
- potential effects on offspring of women with breast implants
- potential effects on reproduction and lactation
- rates of cancer
- rates of suicide
- potential interference of breast implants with mammography
- and MRI compliance and rupture rates.
No implant, according to Dr. Ben Lee, is meant to stay inside the body for more than 20 years, which means replacing the implants at some point. Undergoing implants is a highly personal decision, one that Dr. Lee insists patients make for themselves rather than at the urging of a male friend or husband. His patients who have had breast implants routinely tell the doctor that they feel much better about their physique. “That’s what the surgery is all about in the first place,” adds Dr. Lee.