Dr. ph Bubinak’s Testimony F D A Advisory Panel July 2002

[Guest guest]

" Milk from implanted mothers needs to be tested for

bound and unbound platinum. "

Dr. ph Bubinak’s Testimony F D A Advisory Panel

July 2002

The next speaker, and I apologize if I mispronounce

your name, is Dr. ph Bubinak.

DR. BUBINAK: Thank you, Mr. Chairman and all members

of the advisory panel. I answer no to all four

questions. I am a board-certified hematologist and

medical oncologist. My undergraduate training led to

degrees in mechanical engineering and science. I

retired from active practice two years ago.

One year ago, a former patient with a history of

ruptured breast implant and a low platelet count

called and said she was told that she was, quote, full

of platinum, unquote. Excessive platinum was found in

skin, subcutaneous tissue, blood, urine and

subsequently bone marrow. This interested me because I

have treated patients with platinum-based chemotherapy

since 1976. A low platelet count is a frequent side

effect. The first chemotherapy agent was cisplatin,

which is also mutagenic, carcinogenic, leukemogenic

and teratogenic. Platinum has been found in the milk

of patients treated with platinum compounds.

There is little information in the medical literature

regarding an association of platinum with breast

implants. Unfortunately, not everyone has a good

result. Information obtained from many sources,

including interviews with patients, physicians and

researchers, reveal that some implant patients develop

a variety of systemic complaints including malaise,

hair loss, peripheral neuropathy which is sometimes

disabling, loss of short-term memory, rash and other

allergic manifestations, respiratory systems,

constipation and anorexia, just to name a few. In

short, these are the same side effects people treated

with cisplatin cytotoxic chemotherapy experience.

Increased intensity of systemic complaints commonly

follow gross rupture of the implant.

I was astounded to learn that the catalyst used to

manufacture the silicone for silicone gel and silicone

elastomer for both gel-filled and saline-filled

implants was platinum chloride, a highly reactive

molecule and precursor to the chemotherapy agent

cisplatin. The chemistry of the polymerization process

says that the platinum in ideal proportions is reduced

to its inactive elemental form. This, however, does

not correlate with the amount of platinum found in

tissues both proximate and distant from the implant

site.

Two independent researchers now have found platinum in

excessive concentration in tissues. Capsule formation

around the implant, a frequent complicating event,

tells the world that this device is not inert. Even

without considering the seepage of low molecular

weight silicones, the migration of reactive platinum

alone can explain capsule formation.

One package insert states that the literature suggests

that radiation therapy may increase the likelihood of

capsular contracture, necrosis and extrusion. I have

witnessed this first hand. In this regard, you should

understand that platinum-based chemotherapy is

commonly used explicitly to sensitize the target

tissue to the effects of radiation therapy.

In conclusion, systemic systems do matter and must be

listed as potential side effects in the package insert

when patients are expected to give informed consent.

Likewise, reports of symptomatic improvement in

patients following explantation must also be included.

Despite almost 40 years of clinical experience, there

is not one good, solid, prospective epidemiologic

study available. The largest study that I saw was a

retrospective study, just last year, and that study

showed increased risk for respiratory and brain

cancers, and a non-significant increased risk for

leukemia of various types.

Milk from implanted mothers needs to be tested for

bound and unbound platinum. Reliable, generally

accepted methodology for determining free and bound

levels of platinum in any tissue must be developed

with all speed. Analysis for platinum DNA must be made

available if other critical questions are to be

answered. Long-term ex vivo testing of implants,

subjected to realistic stresses while immersed in

physiologic biologically active media at 37 degrees,

are needed.

Last, from a pure engineering perspective, considering

the failure and complication rates, I wonder what

reasoning could have led to the approval of these

devices. Reasonable assurance of safety and

effectiveness--no one would argue against the

beneficial psychological effects a positive body image

will give. Safety means unhurt, secure from any harm.

I urge this panel to approve only products that are

truly safe and effective for all who desire them.

Thank you.

DR. WHALEN: Thank you, doctor. Any questions??

[No response]