"Micheline B. Lambert" <implants@netrover.com> 
 
Wed, 30 Jun 1999 18:20:02 -0700

To All Of You,
This Letter is at the following add:

http://www.geocities.com/HotSprings/8689/letter.html
It is impossible to be printed the way they posted it.

The Canadian Connection

A MUST! LETTER TO SEND THE PATHOLOGY FIRM BEFORE EXPLANT

If you are going to be explanted, IT IS A NECESSITY to send letter
similar to the following to the pathology department of the facility:
(1) If you have Dow Corning silicone gel implants, (2) You have not or
have been unable to obtain Proof of Manufacturer (3) Have Opted-Out, or
(4) If you have silicone-gel and have not obtained insurance preapproval

prior to explant! Others, consult your support group leaders
and/or attorney to see if they think it is necessary in your case.

By NOT sending a letter prior to explant, IT COULD COST YOU UP TO
$25,000.00, the amount for the rupture bonus for the proposed Dow
Corning Bankruptcy Settlement, if you are having Dow Corning implants
removed, or do not know who manufactured your implants and it turns out
they are Dow Corning or maybe even more, if they are by a manufacturer
filled with Dow Corning gel. READ FURTHER!

If you are being explanted at a free standing same day surgical center
or the operating suite of the P/S, please ask which pathology firm will
be picking up your tissue and implants for the report. Then call this
pathology firm to make sure they still do the pathology consultations
for this surgical center or P/S.

We are amazed how many of the P/S and free standing same day surgical
centers do not realize who the pathologist is for procedures done in
their operating room suite. This might have been changed by their office

manager without them realizing. Your implants and capsular tissue could
end up across town or the country.

It is not the responsibility of a P/S struggling to help us (doctors are

often poor at details so even if they say they will contact the
pathologist, do not count on it!) to make sure the pathologist is
notified of your wishes. Also, the P/S usually does not have time to
carefully examine your implants for a rupture after removing them as
frequently his next patient is already under anesthesia and he must
quickly go on to that person.

And do not assume just because your explanting P/S is famous for helping

us, he has this all worked out with the pathologist. The pathologist is
independent of him. The day of your explant, a brand new one hired by
the pathology firm could be handling your pathology report who does not
realize what is important to do!

At the very least, you need to write to have your implants saved so you
can pick them up within 30 days after explant. If for any reason, you
cannot pick them up in this time period, the letter tells the
pathologist you will contact him so they will continue to hold your
implants.

If the pathologist says they can only be released to your attorney or
some such, discuss this with your P/S. Your breast implants should be
retained indefinitely should you ever need to have them analyzed because

of medical problems (such as what chemicals were in yours). Even if you
have the Product I.D. Tags for your implants giving the Lot and Catalog
numbers, the records of the manufacturers have proved to be far less
than perfect as to what chemicals and how much went in each lot.

Breast implants have been in use only since 1964 and not widely until
the 1980s. It is estimated 60% were implanted from 1986 to 1992.
Silicone gel were banned by the FDA for augmentation with a few
exceptions in 1992. The majority have only been implanted for 6 to 12
years, with an average of perhaps 9 years. We have no idea what the long

term will hold.

A medical journal article reports the latency period is a median of 37
years with a range of 10-68 years, for cases with occupational asbestos
exposure before they developed malignant mesothelioma associated with
it. Asbestos was manufactured starting in 1858 and no one complained up
until the early 1980's or for 127 years.

The local pathologist have for the most part, done nothing but glance at

the newly removed breast implants and unless there is a gross rupture,
they examine them no further for a small opening. This has cost us tens
of millions of dollars in funds from the rupture bonuses being paid by
the manufacturers for good reason. It is time it came to a screeching
halt by asking for a thorough exam (by requesting it in writing prior to

explant) for any opening, including pinhole.

Any opening in the elastomer shell is defined as a rupture; that is the
legal definition given under the
Revised Settlement and the proposed Dow Corning Settlement. The
pathologists are doing a more thorough exam across the board when they
receive the letter shown below! Women have reported their pathology
reports enumerated their implants being gently rolled with mild pressure

to look for a small or pinhole opening. All but one was found even
though there was no obvious rupture.

If you have opted out, be sure your attorney is aware of your
approaching explant. He might wish to have the tissue and implants sent
to a pathologist who has more sophisticated equipment than is available
locally. Most local pathologists do not have the necessary equipment to
affirmatively identify silicone and can only guess whether it is or not,

which might not hold up in court. In any event, he probably will not
want you to ever touch the implants because of the chain of custody (you

could take an ice pick to them!)
and store them or have some pathology firm he has retained do so.

Your medical insurance carrier will only pay for the pathology report
being done one time. The facility will usually require that the
pathologist on sight, or in the case of a free standing one or at the
plastic surgeon's office, the report being done by the one they have
chosen. Unless you have opted out, paying perhaps $950 for a pathologist

with the necessary very expensive equipment, is a nicety and perhaps not

a necessity.

You should instruct the pathologist (by certified mail with a return
receipt, if hand delivered with a copy signed and dated, or by overnight

delivery) to examine them for ruptures or pinholes and to keep your
implants at least 30 days so you can pick them up, do not expect them or

a thorough examine to be done for a small opening.

If pressed for time, you can have a relative or friend who accompanies
you for explant hand deliver a copy of the letter to the pathologist
once you are taken into the operating room and have the employee of the
pathology firm receiving it make a photostat showing and sign, date and
the time it was received and give that back as a receipt your
instructions were received, if they are on site.

If you have been unable to obtain proof of manufacturer, below are the
identifying characteristics that you should print-off to give your P/S
and send with the letter to the pathology firm. If any of these
"identifiers" are enumerated in the operative and pathology reports plus

photographs made of the implants (P/S usually willing to do this), this
might be sufficient for proof and save you the $300 plus overnight
shipping charges to send them to an expert specializing in
identification of the manufacturer. Also, see the
article, HOW TO OBTAIN PROOF OF MANUFACTURE, at this site.

If you are using one of the P/S frequently suggested by support group
members, in as high as 90% of the cases, they will be able to identify
your implants. Also, they are good at obtaining insurance Preapproval
and for producing good cosmetic results with explant only and no
replacements. These P/S will also endeavor to remove your implants "en
bloc," with the capsule and implant as one unit. This procedure
automatically includes a total capsulectomy. By cutting around the
outside of the capsule, the capsule
helps hold any gel together from a rupture or gel bleed, until both are
out of you.

If your explant is not done properly, you could be worse off then you
already are. See the write-up on how explant should be done at the
COALITION OF SILICONE SURVIVORS:
http://www2.privatei.com/~coss/coss/sshead.html For a list of suggested
P/S', most of which are famous for helping us and/or for a suggestion of

an attorney if you live in the U. S., E-mail: Barbara,
Sursiliimp@aol.com.

For further help and support, E-mail Ilena at ilena@san.rr.com and ask
to be added to her post list so that you automatically receive the
latest medical and legal news on silicone implants before the ink even
dries on the articles. You are not alone.

NOTE: IF YOU ARE HAVING SALINE EXPLANTED, PLEASE ADAPT THE LETTER
ACCORDINGLY!

PATHOLOGY DEPARTMENT
XYZ HOSPITAL
1414 S. Whatnot Street
Anytown, CA 99999

CERTIFIED RETURN RECEIPT#_________________________
OR AIRBILL# IF BY OVERNIGHT DELIVERY OR FOLLOWING IF HAND DELIVERY:
ACCEPTED BY (EMPLOYEE OF XZY PATHOLOGY FIRM)
SIGNATURE______________________________TIME__________
PRINT NAME_____________________________DATE__________

RE.: Your Name_______________________Social Security#___________________

Date of
Birth_____________Date Surgery:_______________________
Plastic Surgeon:_________________________

Gentlemen:

I am being operated on by_________________________, M. D. (D.O.), at
approximately _________on (date)__________, to remove my breast implants

and
capsules, at the same day surgical center (hospital or Plastic Surgeon's

in office operating suite) above.

1. Please save my removed breast implants. I will pick them up within 30

days afterwards or give you further instructions in regard to them.

2. Please weigh my implants and place this information in the pathology
report. It is an important medical fact how much they weighed when
explanted as most of us know having obtained the original Product I. D.
Tag how much they weighed when implanted.

For the gross examination, I appreciate you recording the type of
external surface, i. e., smooth, textured, polyurethane or smooth and
covered by sticky material and contents of the implant, i. e., viscous
gel, oil or watery fluid. Please note the color of the gel; at
implantation as you know it was crystal clear. Now it might be yellow.

3. Please also note any inscriptions, including brand name, size and/or
serial number present on the elastomer shell or any identifying
characteristics. I was implanted with the present set, on_____________or

over______years ago. (For those who have been unable to find proof of
manufacturer; please add this: I have been unable to find proof of who
manufactured my implants and would so much appreciate you listing any of

the "identifiers" you see on the elastomer shell which are attached to
this letter.)

4. If there is a rupture, please use that word in your report. The
definition of a rupture is usually any opening in the elastomer shell.
Pathologist have used the term "opening in the capsule" which led to
much confusion instead of saying "opening, pinhole or rupture in the
elastomer shell or envelope." The capsule is generally referred to in
medical circles as the scar tissue surrounding the implant.

Using a word like puncture indicates it was caused by the surgery when
it might not have been. If damage to the implant occurred during the
surgery, it is up to the explanting physician to note that in my
operative report. If the outer shell is focally ruptured (describe the
size of the rupture and whether gel extrudes significantly), if
completely disrupted with fragmentation of the outer shell (in case
saline: completely deflated and flat), small or pinhole opening and
approximate size, etc.

5. If no gross rupture(s) of my breast implants is observed, carefully
examine each by slowly by gently rolling them with mild pressure, to see

if a pinhole or small opening in the elastomer shell can be spotted.
This I consider pertinent information for my health care professionals
for the long-term. Also, any opening, as mentioned, legally qualifies as

a rupture and might qualify me for substantially more funds from the
Settlement I need because of my declining health.

6. Please note if you see what might be metal or dark floating particles

or objects in the silicone-gel (saline).

7. For SALINE only: There were no drugs instilled in the saline solution

when my implants were placed or there was bedatine, cortisone;
antibiotics -- see your operative report at implantation and Office
Notes; help the pathologist -- give him the facts! If the saline
solution looks like "swamp water," since no drugs were instilled (if
true), you might have cultures for a more lengthy time to identify what
is growing in it. Microorganism growing in the saline solution now are
documented to occur more frequently than previously thought. (Don't type

this in the letter; run off the articles, if you are having saline
explanted, in
article #21 at the SALINE IMPLANT LIBRARY and attach those to your
letter:
http://www.GeoCities.com/HotSprings/8689/saline.html

8. Please note the presence and character any inflammatory reaction,
description of foreign material if present, i. e., silicone appears as
refractile, non-birefringent, optically clear material often found
within macrophages. Any giant cells with vacuoles you see, I would
appreciate you mentioning, etc.

An article and a multitude of others, from Annals of Plastic Surgery,
January, 1995 on 300 patients who had 592 silicone-gel breast prostheses

explanted, states there is a 21% chance of one or both are ruptured or
severely leaking (the gel will extend 12 inches which indicates a
pinhole or small opening exists) at 8 years old, 49% at 12 years, 71% at

14 years and 95% at 20 years old. (Only for those with silicone gel)

Please be sure to note if there is granulation tissue, silicone
granulomas on the exterior of the biological capsule, lymphocytes, foamy

histocytes, macrophages, mast and/or multinucleated giant cells, plasma
cells, eosinophils, foci of epitheloid cells and fibroblasts, everything

you see that might be considered a foreign body or immune reaction or
fluid between the capsules and implants, synovial metaplasia, etc. There

are also increasing reports of squamous cell carcinoma in the capsule
surrounding a breast implant.

I need your help again to please note everything when doing my Pathology

Report. It might help my health care professionals in treating me over
the long-term. Thank you so much for your efforts on my behalf.

Sincerely,

X__________________
MARY JANE DOE

Enc.: Subclinical Infections, Synovial Metaplasia and Squamous Cell
Carcinoma Associated with Breast Implant Capsule.

Note: The above articles are after the list of Characteristics below;
you can copy and paste them into your word processing program plus the
requirements for proof of rupture from the proposed Dow Corning
Bankruptcy Settlement and the "identifiers," for all of the
manufacturers, if you still in need of proof of manufacturer and then
print them off to attach to your letter)

PROOF OF RUPTURE REQUIREMENT DOW CORNING:

(e) Rupture Payment Option. To qualify for the Rupture Payment Option a
Breast Implant Claimant must meet the requirements listed below:

(i) Definition. "Rupture" means the failure of the elastomer envelope(s)

surrounding a silicone-gel Breast Implant to contain the gel (resulting
in contact of the gel with the body), not solely as a result of "gel
bleed", but due to a tear or other opening in the envelope after
implantation and prior to the explantation
procedure...

(iii) Rupture Proof.

...Breast Implant Claimants explanted after January 1, 1992 and before
the Effective Date must submit a contemporaneous operative report and,
if available, a pathology report together with a statement as to whether

the ruptured implants have been preserved and, if so, the name and
address of the custodian.

c. 1. Breast Implant Claimants explanted after the Effective Date
(probably June/July) must submit a contemporaneous operative report and,

if available, a contemporaneous pathology report. In addition, the
Claimant must provide a statement from the explanting surgeon (or other
appropriate professional approved by the Claims Office) affirming that,
in his or her opinion, the Rupture did not occur during or after the
explantation procedure. This statement must describe the results of the
inspection and provide a factual basis for the opinion (e.g., in light
of silicone granuloma formation on the exterior of the biologic capsule,

or findings concerning the nature of the destruction of the elastomer
envelope). The Claimant shall use her best efforts to cause the removed
implant to be preserved...


LIST OF CHARACTERISTICS UNIQUE TO SPECIFIC
MANUFACTURERS OF IMPLANTS

BRISTOL-MYERS

1. Polyurethane (for implantations before 9/1/71 or after 12/8/78)
2. Bilumen implants described as having a standard gel implant within,
but not attached to, an outer inflatable elastomer shell.
3. An implant having an SSI valve. An SSI valve can be mentioned by
name, or by description: a circular valve that looks like a button,
having a slightly rounded dome. It is Dacron-mesh reinforced.
4. An implant having a Quin-Seal valve. (This valve is flat and its
entry site is marked with a white dot.)
5. An adjustable reconstructive implant with two puncture seal sites
(shell and column).
6. An implant with "SCL" molded on the shell.
7. An implant with radiopaque size markers.
8. For implantations before 9/1/71 or after 12/8/78, an implant shell
exhibiting roughness due to adhesive can be treated as a "polyurethane"
implant even if the foam cover is gone.

BAXTER (HEYER-SCHULTE)

1. Polyurethane (for implantations 9/1/71 to 12/8/78).
2. For implantations 9/1/71 to 12/8/78, an implant shell exhibiting
roughness due to adhesive can be treated as a "polyurethane" implant
even if the foam cover is gone.
3. An implant with horizontal thin silicone tubing approximately 1mm in
diameter. The tubing lies from edge to edge of patch for orientation
purposes. Ends of tubing are "RTV'd" closed.
4. An implant with a butterfly silicone fixation patch which is
perforated to allow tissue ingrowth. The edges of the patch, but not the

face, are adhesed to the main patch.
5. An implant with a molded or cast number composed of a single letter
A, B, or C and followed by a single-digit number.
6. An implant with a "spiral" or "target" imprinted design composed of
concentric rings located on the main patch.
7. An implant with a retention valve positioned at acute angle to
flange.
8. An implant with a diaphragm (Jenny) valve placed on the anterior face

of the implant. (On round styles, valve will be at apex of the anterior
face.)

Baxter identifiers 3 - 8 above relate only to implantations before
3/31/84.]

3M (MINNESOTA MINING & MANUFACTURING)

1. An implant with "3M" or "3M McGhan" stamped on the outside of the
envelope.
Relates to those implants manufactured before 8-3-84 only.

MCGHAN

1. An implant with "McGhan" stamped on the outside of the envelope.

DOW CORNING: UNIQUE PRODUCT IDENTIFIERS:

A photograph of an explanted Breast Implant that shows one of the
characteristics unique to a Dow Corning Breast Implant, as specified at
Section D, below, if the photograph is accompanied by a statement from
the explanting physician identifying the Breast Implant in the
photograph as one (s)he removed from the Claimant. I have asked my
Plastic Surgeon to photograph my implants once removed.

DELETE the following sentence in what you give the pathologist; it is
directed only to you: If you need the pathologist to do this, you should

call ahead of time to arrange it. If they do not have a camera, even if
you have to go out and buy an inexpensive Poloroid one or borrow a
camera for them, do so!

The following unique product identifiers of a Dow Corning Breast
Implant(s) shall be considered as acceptable proof where the removed
implants are examined by a physician who identifies the manufacturer or
brand. See paragraph 7 of Section B above:

For implantations or implants manufactured between 1969 and 1973 a high
profile contour "ski slope" design implant with Dacron® fixation patches

on the posterior with the upper portion of the implant being concave and

the bottom portion convex. If the fixation patch has detached from the
implant, then the Claims Office shall accept and shall deem as
acceptable proof a photograph of the implant showing an imprint
consisting of 3-4 linear impressions of the Dacron® mesh embedded in the

elastomer shell.

An implant with fixation patches where white Dacron® knit mesh loops
were either sewn or bonded to the elastomer patch surface with the
fixation patches in turn bonded to the envelope posterior. Products with

the following configurations of fixation patches are acceptable:

(i) For implants implanted or manufactured between 1963 and 1965, a
single large Dacron® mesh-reinforced fixation patch covering all or
almost all of the posterior implant surface of a silicone gel-filled
implant with a prominent non-everted peripheral seam where the fixation
patch is constructed of Dacron® mesh-reinforced silicone elastomer
sheeting to which non-embedded Dacron® mesh had been sewn with Dacron®
sutures. (1963-1965)

(ii) For implants implanted or manufactured between 1963 and 1969, four
(4) Dacron® mesh-reinforced fixation patches, one in each quadrant on
the posterior implant shell, asymmetric or symmetric, with a distinct
peripheral seam everted or non-everted, where the fixation patches are
constructed of Dacron® mesh-reinforced silicone elastomer sheeting to
which non-embedded Dacron® mesh has been sewn with Dacron® sutures.

(iii) For implants implanted or manufactured between 1968 and 1982, two
(2) to five (5) circular Dacron® mesh fixation patches on the posterior
implant shell of the embedded/pleated design, consisting of a clear
elastomer disc about 22-25mm diameter, with a pattern of embedded
Dacron® mesh in a pleated pattern, with the actual Dacron® mesh present
or absent.

     SUBCLINICAL INFECTION OF THE SILICONE BREAST IMPLANT SURFACE AS A
POSSIBLE CAUSE OF CAPSULAR CONTRACTURE

Author: Virden CP; Dobke MK; Stein P; Parsons CL; Frank DH
Address: Division of Plastic Surgery, University of California, San
Diego 92103.
Source: Aesthetic Plast Surg, Spring, 1992, 16:2, 173-9

Abstract: In order to reexamine the possible association between
bacterial presence and capsular contracture, 55 silicone devices
(mammary implants or tissue expanders) were cultured at the time of
their removal from 40 patients. Special culture techniques were used in
an attempt to recover bacteria adhering to the smooth-surfaced implant
and encased in glycocalyx biofilm. Bacteria were detected on 56% (15 of
27) of implants surrounded by contracted capsules and on 18% (5 of 28)
of those without capsular contracture (p less than 0.05). Only three
implants tested positive using routine plating techniques. The
predominant isolate was Staphylococcus epidermidis. The concept that
capsular contracture is associated with subclinical infection of
silicone implants is supported by this study. With changes in the
microbiological technique, bacterial recovery and growth occurs at a
frequency greater than previously thought.

    EPITHELIALIZATION OF THE LINING OF BREAST IMPLANT CAPSULE: POSSIBLE
ORIGINS OF SQUAMOUS CELL CARCINOMA (CANCER) ASSOCIATED WITH BREAST
IMPLANT CAPSULE

Author: Kitchen SB; Paletta CE; Shehadi SI; Bauer WC
Address: Department of Pathology, St. Louis University Medical Center,
St Louis University School of
Medicine, MO 63110.
Source: Cancer, 1994 Mar, 73:5, 1449-52

Abstract: The authors described a Case in which the capsule surrounding
a breast implant was lined by benign squamous epithelium. A second Case,

in which a woman was found to have a squamous cell carcinoma in the
capsule surrounding a breast implant, was also reported.

                       SYNOVIAL STRUCTURE OF BREAST-IMPLANT-
                                    ASSOCIATED BURSAE
Author: Emery JA; Spanier SS; Kasnic G Jr; Hardt NS
Address: Department of Pathology and Laboratory Medicine, University of
Florida College of Medicine,
Gainesville.
Source: Mod Pathol, 1994 Sep, 7:7, 728-33

Abstract: Over 2 million silicone breast prostheses have been implanted
since they were introduced in the 1960s. After implantation, a
fibrovascular tissue reaction referred to as a "capsule" is observed.
Many consider this capsule to be a static structure, an effective
barrier to the egress of foreign material. However, reports documenting
the presence of silicone within lymph nodes of patients with apparently
unruptured implants indicate that silicone may be transported away from
the breast-implant capsule. To characterize the cells making up the
breast-implant capsule, 183 capsules from 103 ruptured or bleeding
implants and 80 intact implants were studied.  Gross and light
microscopic studies were performed on all, and selected capsules were
subjected to ultrastructural study and Fourier-transform infrared
spectroscopy. Light microscopic examination of the
capsule revealed an organized, layered structure with an associated
network of endothelia-lined spaces. The capsules varied in cellularity,
depending on the type and integrity of the implant. The superficial cell

layer of all capsules had cytoplasmic processes directed toward the
surface. These long cytoplasmic processes contained vacuoles
ultrastructurally, indicating phagocytic and pinocytotic capability.
These cells bore immunological markers of bone marrow derived
macrophage-type cells. The
extracellular matrix of the surface layer consisted of an amorphous
fibrillar protein lacking the ultrastructural periodicity of mature
collagen. No cell-to-cell junctions were observed. Deeper capsular
layers were characterized by fibroblast-type cells in a collagen matrix.

No capsules studied contained basement membrane or basal lamina between
the stroma of the capsule.

THE BELOW IS ONLY FOR YOUR BENEFIT AND IS NOT TO BE GIVEN TO YOUR P/S &
PATHOLOGIST WHO ALREADY HAVE GIVEN ENOUGH TO READ!

(b) Definition of Minor Deficiencies in Rupture Proof. There are four
minor deficiencies in Rupture proof.

If a Breast Implant Claimant's Dow Corning Breast Implant was removed
before the Effective Date, the Claim has a minor deficiency if the
Breast Implant Claimant failed to state whether the ruptured implant has

been preserved and, if so, the name and address of the custodian.

If the ruptured implant was removed after the Effective Date (probably
June/July, 1999), the Claim has a minor deficiency if the Breast Implant

Claimant failed to provide the Claims Office with the required statement

concerning preservation of implants or failed to provide a statement
>from the explanting surgeon (or the hospital pathologist, a physician
who assisted in the explantation surgery or from another doctor who
examined the removed implant, as provided herein) affirming that, in his

or her opinion, the Rupture
did not occur during or after the explantation procedure and providing a

factual basis for that opinion.

Note: If you have an attorney, he will be able to tell, hopefully,
whether this is necessary to obtain as frequently, the P/S puts this
statement or the equivalent of it in the operative report. If it is not
sufficient in the operating report, your attorney will write the P/S for

you. Also, you have two years we believe from the effective date to be
explanted unless because of your medical condition, you probably would
not make it through explant, to have your breast implants removed to
prove a rupture. See the section on Proof of Rupture on the medical
conditions and then how a rupture would need to be documented if you
feel you could not make it through the surgery.

If the Claimant was explanted after January 1, 1992 but did not submit a

pathology report or indicate that the pathology report was unavailable,
the Claim has a minor deficiency that can be cured by submission of the
report or the required statement.  If the Claimant timely submitted the
supporting documentation demonstrating Rupture but did not submit
a Rupture Payment Option Form, the Claim has a minor deficiency which
can be cured by submitting the Rupture Payment Option Form.

Breast Implant Claimants may cure deficiencies in Rupture proof by
sending to the Claims Office the appropriate written statement, clearly
marked at the top as Rupture Proof.