NOTE: Ilena Rosenthal and the Humantics Foundation share Dr.
Bosshardt's concerns ... and more. We thank him for raising important
questions.
www.BreastImplantAwareness.org
Too soon to rave on gel breast implants
Dr. Richard T. Bosshardt | Special to the Sentinel
Posted April 8, 2007
http://www.orlandosentinel.com/featu...alth-headlines
Excerpt: I have a significant concern, shared by many plastic
surgeons, regarding conditions placed on the use of gel implants by
the FDA. One condition is that women who get gel implants must agree
to have an MRI (magnetic resonance imaging) study of their breasts
three years after implantation, and every other year after that. No
provision is made for how to enforce this.
The reason for this recommendation is that leaks in gel implants are
nearly impossible to detect by examination. Using MRIs as screening
exams for leaks is problematic. They are not foolproof and can miss a
leak, or diagnose a leak when one doesn't exist. MRIs cost about
$2,000, and insurance will not cover them The significance of a small
leak in cohesive gel implants is still unknown. Asking women to commit
to repeated, expensive MRIs of questionable value does not seem
reasonable.
http://www.orlandosentinel.com/featu...alth-headlines
Question: Why haven't you written anything about the new gel breast
implants approved last year by the Food and Drug Administration? Are
these really safer than the old ones? Are they better than the saline
implants?
Answer: I have some ambivalence about the new gel implants. Although
silicone gel implants always have been available for reconstructive
purposes, a moratorium from 1990 until 2006 prohibited their use in
cosmetic breast surgery. This was because of concerns that they caused
a variety of illnesses. Further studies eventually put these fears to
rest, but it may take decades to rule out all risks with certainty.
In November 2006, the FDA lifted the moratorium. This would appear to
be reason for plastic surgeons and their patients to celebrate, and a
vindication of sorts, but things are not as simple as they might seem.
The old implants contained a more liquid, runny gel. When these
implants leaked or ruptured -- one of the known risks of implants --
the gel could migrate out of the implant pockets. Some associated
problems include: contracture or hardening of the breasts, calcium
deposits around the implants and lumps in the breasts. The new
implants have a more viscous, or cohesive, gel. In some, you can
actually cut the implant in half and the gel will not leak out.
While this can be a plus, the newer implants have some disadvantages.
They are not as soft as the old ones and they must be inserted through
a longer incision. A saline -- or salt water-filled -- implant can be
inserted empty through an inch-long incision and filled inside the
breast. A new gel implant requires at least a 3-inch incision.
Saline and gel implants each have advantages and disadvantages. Before
surgery, the gel implants feel more like breast tissue. However, once
inserted, the differences are much less obvious and both can produce
very natural results. Although saline implants are more likely to leak
over time, this is harmless to patients. They can be replaced easily.
Gel implants are much more expensive. Because they may be less likely
to show ripples or wrinkles, gel implants are sometimes preferred for
patients with thin tissue, including those who have undergone
mastectomies.
I have a significant concern, shared by many plastic surgeons,
regarding conditions placed on the use of gel implants by the FDA. One
condition is that women who get gel implants must agree to have an MRI
(magnetic resonance imaging) study of their breasts three years after
implantation, and every other year after that. No provision is made
for how to enforce this.
The reason for this recommendation is that leaks in gel implants are
nearly impossible to detect by examination. Using MRIs as screening
exams for leaks is problematic. They are not foolproof and can miss a
leak, or diagnose a leak when one doesn't exist. MRIs cost about
$2,000, and insurance will not cover them The significance of a small
leak in cohesive gel implants is still unknown. Asking women to commit
to repeated, expensive MRIs of questionable value does not seem
reasonable.
Until some of these concerns are better addressed, it's premature to
wholeheartedly embrace widespread use of gel implants for cosmetic
surgery.
Richard Bosshardt is a plastic surgeon in Tavares. If you have a
medical question, send it to him at 1879 Nightingale Lane, Suite A-2,
Tavares, FL 32778 or e-mail
rtbosshardt@aol.com.
Some sound advice from a Plastic Surgeon ... Too soon to rave on gel breast implants 
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