A New Look at Breast Prostheses

After a woman has undergone a mastectomy, she may wrongly assume that a
breast reconstruction or generic, off-the-shelf breast forms are the only
options for the restoration of symmetry and balance.

“Post-mastectomy services, in general, are discussed secondary to
reconstruction when a woman has had surgery,” Rhonda Fletcher Turner,
PhD, MBA, JD, CFM, BOCPO,
president of the American Association of Breast
Care Professionals, said. “Sometimes, it’s the only option that is
discussed.”

However, often a woman is not a candidate for surgical reconstruction or
she might be hesitant about undergoing another surgery.

“After having a mastectomy, women are still in the process of
fighting for their lives in terms of getting the cancer under control,”
said Jay Markowitz, co-chief executive officer of American Breast Care,
a manufacturer of silicone breast prostheses located in Marietta, Ga. “And
a lot of times, the last thing that they want to do is go under the knife
again.”

Breast implants also require replacement after several years, and in
instances in which a woman has undergone a unilateral mastectomy,
reconstruction is not always ideal because as the woman ages, the implant will
remain in place but the body will begin to change.

 

“If the reconstruction is successful, the best it is ever going to
look is that first day,” Markowitz said. “Your body begins to age
naturally, but that implant just stays where it is. Over time, it’s not
going to look as good as it used to.”

In a situation such as this, a breast prosthesis will allow a woman to
retain symmetry without undergoing another surgery, and over the last few
decades, breast prostheses have improved significantly. Today, a woman can
choose from a variety of shapes, weights, colors and sizes that appear and feel
life-like, which are waterproof and can be worn while swimming or exercising.

“We have well over 1,000 choices of breast forms that we offer in a
combination of different shapes, weights, sizes and colors,” Markowitz
said.

“Using silicone allows you to make the product life-like and
natural so it is comfortable for the woman,” Jolly Rechenberg,
chairman and co-chief executive officer of American Breast Care, said.
“Our products are not only life-like, but also soft enough to pass what we
call the hug test, which is when someone goes in for a hug, the product will
feel comfortable and natural and no one will recognize [that it is a breast
form].”

Jay Markowitz

Jay Markowitz

 

To ensure that the prosthesis is comfortable and appropriate, it is
necessary that a patient is seen by a certified mastectomy fitter. American
Breast Care works with orthotic and prosthetic clinics and other retailers to
distribute its products.

One of the benefits of prefabricated breast forms is that a woman can
walk out with a prosthesis the same day as her fitting, and according to
American Breast Care, that is important to a lot of women.

“Psychologically, it is a big step for a woman to go in and get
fitted. There is an incredible desire and need for that woman to walk out with
a fitted product,” Rechenberg said. “So we tell our customers and
retailers that it is important that they have a certain inventory so that the
woman can walk out and be comfortable. Otherwise she may not come back.”

Jolly Rechenberg

Jolly Rechenberg

 

American Breast Care encourages their retailers to have a variety of
breast forms in stock, but if a patient desires something different, it can be
shipped within 24 hours.

“What most retailers do is keep an inventory of one or two choices,
and if those don’t work, then they can phone us, and we will send out
whatever prosthesis is needed either the same or next day,” Markowitz
said.

Custom breast prostheses

Despite the benefits afforded by pre-fabricated breast prostheses,
sometimes a woman is not a candidate for an off-the-shelf device. She may have
had excessive tissue removed from the chest wall, lymph nodes removed from
axillary area or have already had a failed reconstruction, and in those
situations, a prefabricated device will usually not sit correctly or
comfortably on the chest.

Custom and off-the-shelf breast prostheses give women options their surgeons may not have told them about.

Custom and off-the-shelf breast prostheses give women options their surgeons may not have told them about.

Image: courtesy of Irene Healey

 

“There are a significant amount of sizes, shapes, weights and
technologies that are premanufactured that many women prefer,” Turner
said. “But there is also a segment of the breast cancer survivor
population that cannot wear those premanufactured forms.”

Irene Healey, a certified clinical anaplastologist and the
founder and director of New Attitude, noticed this disparity and began looking
at ways to develop custom breast prostheses.

“There was a gap for people who couldn’t find something
off-the-shelf, and that gap had be addressed because there was a significant
need,” Healey said. “We developed our own material and spent a lot of
time creating something that is biomimetic, lightweight and that reflects the
person’s anatomy.”

Custom breast prostheses are made with a lighter silicone material than
prefabricated devices and are created specifically for an individual patient.
The back of the prostheses fits like a puzzle, reflecting the patient’s
chest wall and filling in any gaps or invaginations resulting from the
mastectomy. The intimate fit also removes the need for a pocketed mastectomy
bra.

In the past, the process of creating custom breast prostheses was
lengthy and impractical because a plaster mold had to be taken of the
woman’s chest. However, the use of digital technology has greatly
simplified the process and improved precision.

“Scanning and 3-D printing really open up a lot of possibilities
and empowers the providers of care to do something restorative and in keeping
with what people need,” Healey said.

 

Wendy Carter

Wendy Carter

Wendy Carter, CFoM, LPN had a similar idea when she pioneered the
use of 3-D scanning technologies at Ability Prosthetics and Orthotics, Inc. Now
the director of clinical operations for Symmetry, Ability’s
post-mastectomy division, Carter emphasizes the importance of utilizing this
technology.

“If you compare 3-D scanning to plaster molds, you have less time
spent on doing a plaster mold and fewer materials,” Carter said. “And
you have a much happier patient.”

The scanning process occurs in two parts. First, a scan is taken of the
bare chest wall to capture any depressions, invaginations or scar tissue. A
second scan is then taken while the patient is wearing a bra and breast forms
to create the desired slope and shape of the device. The two scans are then
merged to create the design of the custom prosthesis, which is sent to a carver
to be fabricated. The entire scanning process occurs in a matter of minutes, a
vast improvement over plaster molding, which could take up to 2 hours to
complete.

Improving awareness

Although there are a myriad of benefits associated with breast forms,
both custom and prefabricated, many breast cancer survivors are unaware tof
these options. Part of that problem may lie in the information presented by
their health care professionals.

“When I speak with surgical groups and breast surgeons, a lot of
them have never seen or touched a breast prosthesis or never actually referred
a patient,” Carter said. “But when they see the actual device, they
are extremely excited about having that option, because every patient is not a
candidate for reconstructive surgery.”

“With surgical reconstruction, the information is there and readily
accessible,” Healey said. “Women may assume that the information that
they are given about breast prostheses is all there is. They may be
unaware.”

Turner expressed similar concerns, saying that the perception of
reconstruction is contributing to the problem.

Healey’s patient Norah Jackson leads an active lifestyle post-mastectomy.

Healey’s patient Norah Jackson leads an active lifestyle post-mastectomy.

Image: courtesy of Norah Jackson.

 

“When we think of breast forms and custom forms, we think of
augmentation. There is a very fuzzy line of understanding between augmentation
and the restoration of physiological symmetry,” Turner said. “So I
think we have a lot of educating to do, because we are good at knowing how to
organize and fight breast cancer, but we are still learning as a profession how
to organize and educate and provide breast cancer survivor services.”

This inconsistency presents an excellent opportunity for the O&P
industry to increase its presence in the breast care industry.

“I think there is an entire population out there that is
underserved for breast prostheses, and I think that is a really good adjunct to
an O&P clinic if it is treated as a part of [health care],” Healey
said.

“It is perfect for O&P, specifically, because custom breast
forms are provided by CAD/CAM technology,” Turner said. “Just like
O&P has progressed into the digital age, so have breast forms, and many of
the programs and scanners needed are already sitting in O&P offices. It is
an easy flow to offer [breast care] services in an O&P office that is
already using scanner technology.”

Even if an O&P facility chooses not to fabricate custom devices or
utilize scanning technologies, fitting services can still be offered. According
to American Breast Care, they will provide all of the necessary training and
preparation for a facility to begin offering fitting services.

“We do all of the training that is needed to make someone a
confident fitter. They will have to plan to get a fitting certification, but we
can prepare them to take that test,” Markowitz said. “We will also
help them select product choices that would make sense for them to keep in
stock.”

Markowitz also said that American Breast Care can provide customized
marketing and promotional materials in order for a facility to increase
awareness about the services it provides.

“The incidence of breast cancer increases the older that we become,
and we have the baby boom generation, so there is a whole market that is
underserved and just waiting for products to address their needs,” Healey
said. “It opens up a whole revenue stream and client base for the O&P
industry that wasn’t there before.”

The Medicare fight

Medicare, Medicaid and most private insurance providers offer full
coverage for prefabricated breast forms and mastectomy bras. And while most of
private insurers and some state Medicaid plans provide reimbursement for custom
breast prostheses, Medicare recently withdrew its coverage.

“One of the problems with post-mastectomy, whether it’s custom
or not custom, is that a lot of people don’t know about this need and view
breast forms as cosmetic in nature,” Turner said. “They don’t
see breast forms as a medical need or necessity. And that is the problem with
Medicare — they don’t think custom breast prostheses are medically
necessary.”

According to Healey, societal perception of breasts and breast care is
negatively affecting the treatment of breast prostheses in the medical
community.

“I think we need to stop categorizing breast prostheses as
women’s items, and see it as an amputation of a body part,” Healey
said. “It is actually a complicated prosthetic device because the torso
moves in so many directions and the bra adds a layer of complication. There are
lots of reasons why the cost [of the device] needs to reflect the precision and
care that goes into making the device well.”

In June 2011, Sen. Olympia Snowe (R-Maine) and Rep. Mike Ross (D- Ark.)
introduced the Breast Cancer Patient Equity Act to the Senate and House of
Representatives, respectively, which aims to amend title XVIII of the Social
Security Act and restore coverage for custom breast prostheses.

“Senator Snowe and Representative Ross are extraordinarily
committed to the passage of this bill,” Turner said. “Right now, we
are trying to raise awareness about the bill and differentiate this bill and
the need for these services from casual cosmetic issues.”

Because Medicare is the benchmark plan for most insurance plans, if this
bill is not passed, other insurance providers might start adopting
Medicare’s policy.

“There are a significant number of women for whom custom is the
best solution,” Healey said. “[Medicare’s denial of this
service] prejudices private insurers for women under 65. If Medicare deems
[custom breast prostheses] not medically necessary, than some of the argument
that women have for other insurers to cover it is removed.”

“Unfortunately it’s a drop in the bucket compared to the needs
of most Medicare patients,” Carter said about the bill. “However, if
you have somebody who is a recipient of Medicare, and [a custom device] is what
they want, it’s heartbreaking for them.”

The out-of-pocket cost for a custom breast prosthesis can range anywhere
from $2,500 to $3,000 which is often unaffordable for most Medicare recipients.

“The majority of women who are diagnosed with breast cancer are
over 65, so I find it interesting that once you hit 65, when the need [for
custom prostheses] is greatest, the ability is not even just denied, it’s
completely cut off,” Turner said.

Turner is optimistic that the bill will get passed in the near future,
but it will need a lot of help from the O&P community.

“We are not going to get it done without a considerable amount of
help from a lot of different people, and I think it’s something that the
O&P community can do,” she said. “We have had this fight with
other products and services. It just makes sense for the entire profession to
get behind something like this because it adds to what we all do and the
services that we can provide.” — by Megan Gilbride

Disclosure: Healey is the owner of New Attitude. Markowitz and
Rechenberg are the owners of American Breast Care. Carter and Turner have no
relevant financial disclosures.

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