Thinking of Buying...Breast Implants

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How to select and stock saline implants, and readying for silicone's return.


Your breast implant choices may seem limited, since at present only saline-filled implants are available to women undergoing cosmetic breast augmentation and since only two manufacturers - Inamed Aesthetics and Mentor Corporation, both of Santa Barbara, Calif. - are FDA-approved to supply them. But the range of sizes and variables designed to accommodate different body types and desired outcomes presents a number of questions when it comes to purchasing and stocking implants. The possible return of silicone gel-filled implants could also complicate the process. Here's advice on buying implants with economy and efficiency in mind.

Implant aesthetics
Most of the breast implants used in cosmetic procedures consist of silicone shells with integrated valves and detachable filling tubes. Saline implant shells are empty when purchased. During surgery, they're folded, inserted through small incisions and filled. The filling tube is then removed and the self-closing valve seals.

Implants are catalogued according to their varying sizes, shapes, dimensions and shell sizes. Sizes range from 100cc to 800cc in increments of 30cc or 50cc. Each size of implant is available in a variety of dimensions, giving the surgeon a range of choices in affecting the shape and size of the breast. The surface integrity of the shell is either smooth or textured; while smooth implants have a thinner shell, the textured are said to better resist capsular contracture. In terms of shape, implants are either round or contoured - also known as shaped, teardrop, anatomical or biodimensional.

The patient may choose her desired outcome, but it's the surgeon who determines which implant options will best do the job. "Patients don't have a particular idea about moderate- or high-profile, smooth or textured," explains Jill Young, RN, patient coordinator and office manager for Body Aesthetic Plastic Surgery in St. Louis. "That information comes out of the physician's examination."

Supplying the demand
Those who run plastics practices, however, have decisions of their own to make. Perhaps the most basic question, given the range of implant options available, is whether and how to stock them on site.

"The biggest advantage to stocking them," says Lloyd Krieger, MD, medical director of Rodeo Drive Plastic Surgery in Beverly Hills, Calif., "is that you have a spectrum of sizes on hand. You don't have to make a definite decision before surgery on which size you're going to need."

For a practice that does a high volume of implant cases, this may be the economical choice. "We buy by the case," says Dr. Krieger. "It's more cost-effective, even though it's a big expense up front." Rodeo Drive stocks the smooth, round, moderate profile implant in several volume sizes. "Everything else, we special order," he says.

Inamed Aesthetics: Style 68 Saline Matrix
(800) 624-4261 www.inamed.com
Price: $550 each
FYI: Inamed's Style 68 Saline Matrix breast implants offer three projection sizes: low-, moderate- and high-profile, each with the same base diameter, the company says, allowing the surgeon the flexibility to select the round, smooth implant that meets the patient's expectations without compromising the base width.

Mentor Corporation: Moderate Plus Saline Implant
(800) MENTOR-8 www.mentorcorp.com
Price: Not provided
FYI: The Moderate Plus is the newest addition to Mentor's family of saline breast implants. Its dimensions are sized between Mentor's moderate- and high-profile saline implants and is the ideal complement to the saline product family, the company says. To accommodate a full range of body types, the Moderate Plus implant is offered in 20 sizes with fill volumes ranging from 175cc to 960cc.

Ms. Young's practice follows a similar method. "We have a consignment of our most common sizes used in moderate- and high-profile," she says, "but I have to be predictive. I have to have lots of choices on the shelf, but they have to be sizes we'll use. It's a balancing act, a guessing game."

Staying abreast of your case mix can help with ordering inventory, she says. "We tend to see larger augmentations rather than smaller. That's probably because our average patient tends to be older, done with childbearing, with more skin and more space to accommodate an implant. We know pretty well who our patient is."

Phil Haeck, MD, medical director of the Seattle practice that bears his name, notes that buying in bulk also means keeping an eye on your store room. "The hardest part is to track them," he says. "If you have two or three people haphazardly doing inventory, and they fall behind, you're going to have what the retail industry calls 'shrinkage,'" he says.

The danger in not stocking an inventory of implants is that the surgeon has a little less flexibility on the day of surgery.

Dr. Haeck says his surgeons are precise enough to order three implants per case, including an extra just in case of a defect or mishap, and send the extra back. "Set up a shipping arrangement," he advises, "so you don't have to pay a lot to send 10 back every week."

At Ms. Young's facility, surgeons rely on plenty of backup when ordering implants, calling for as many as 15 implants for a case: three of the planned size, then three each of the next two sizes up and down, in the event of unexpected discoveries such as asymmetry or scar tissue buildup. The unused implants are shelved or returned.

"It's imperative for a facility manager to make sure staff ships the implants back before the bill comes," says Dr. Haeck. "The biggest disappointment for a surgeon is being billed for implants that weren't used, because then they might just disappear. No one wants to pay for implants that can't be found."

Choosing sides
Both of the companies currently manufacturing saline-filled implants for the U.S. market offer similar styles and options. How do you choose one manufacturer from the other? Should you? Dr. Krieger lists three potentially deciding factors: price point, customer service and physician preference.

On price, he says, "it is a challenge. The challenge is that the price is not fixed. There are volume discounts on different-sized orders, so you have to pay close attention to what you're ordering and make decisions about what you're buying.

The Silicone Story

When silicone gel-filled breast implants were developed in the early 1960s, medical devices weren't regulated for safety and effectiveness by the U.S. government. The Medical Device Amendment of 1976, however, gave the FDA the authority to set standards and govern the marketing of such products.

The amendment opened the door for the federal government's 1992 ban on the use of silicone implants in cosmetic breast augmentation procedures. The ban, which followed concerns that ruptured or leaking implants had caused serious illnesses in patients, limited silicone to reconstruction procedures and controlled studies.

Studies conducted in the late 1990s cleared silicone implants of any link to cancer, lupus or other chronic conditions, but implants have been shown to cause painful scar tissue, infections and other surgical complications in some patients.

Mentor Corporation and Inamed Aesthetics have submitted silicone gel-filled implants to the FDA, seeking approval to again market the products for U.S. cosmetic use. The newer versions are said to be safer and more durable. In April, an advisory panel to the FDA recommended approval for Mentor's, under a series of conditions. The panel withheld its approval of Inamed's pending additional data.

The conditions, intended to control access to the product, would require patients to sign consent forms acknowledging the potential risks of the implants; would ensure that the implants are only sold to board-certified plastic surgeons who complete product training; would create a database to conduct long-term research on the implants' durability and effects, and the health of their users; and would encourage patients to undergo periodic MRI scans to detect leakage.

- David Bernard

"You have to be very watchful with regards to billing," adds Dr. Krieger. "Make sure you know that what you got charged for, you received."

"Certainly cost is a factor," says Ms. Young. "But for us, the issue is customer service from the company's rep. Ours always helps us out when situations change despite everyone's best planning."

Ms. Young's access to the representative, as well as his ability to deliver a needed implant on short notice or at least locate it at a nearby facility, led her, in consultation with her surgeons, to choose one manufacturer over the other.

Physicians are just as likely to use styles from both manufacturers as they are to be loyal to one. "The facility needs to know what a surgeon prefers," says Dr. Haeck. "Staff often can't remember what type surgeons like, and - guess what - surgeons sometimes change their minds. Efficiency in that case depends on the staff staying on top of preference cards."

The return of silicone?
Thirteen years after a federal ban on their cosmetic use, silicone gel-filled implants may be returning to the U.S. market. In July, the FDA issued an approvable letter - one of the steps toward its approval of new products - to Mentor for a new version of silicone implants. Inamed is also testing a new silicone product, though it hasn't yet received the agency's preliminary approval.

Silicone gel implants are said to offer a more natural feeling and looking implant than saline-filled implants, but are two times to four times as expensive as saline and have a history of hardening. What would the product's approval and resulting demand mean for facilities? In addition to the new training doctors may have to undergo, patients will have to be educated as well, says Dr. Haeck. "It's going to double consultation time to explain the differences between silicone and saline," he says.

"The question we're going to have to ask ourselves is, once again, are we going to order stock, or on a case-by-case basis?" says Ms. Young. "I don't have a clear feel for the demand yet, and some women are still a bit leery about silicone."

"Silicone will make stocking and pre-purchasing decisions considerably more complicated," adds Dr. Krieger. "There's no question that a large percentage of patients will want silicone. We'll have to see how large that percentage is." He adds that there will most likely be a wait-and-see period to judge whether it pays to stock silicone and saline.

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