Re: Bits and Pieces...from DOW implant debris and complications

[Guest guest]

Wow, there it is, straight from the horse's mouth!

claims from clinical use of the silicone prosthesis in humans

> suggest that immunological responses or sensitization to a mammary

prosthesis can

> occur. If sensitization is suspected and the response persists,

removal of the

> prosthesis is recommended along with removal of the surrounding

capsule tissue.

> This procedure is recommended along with removal of the surrounding

capsule

> tissue. This procedure is recommended to minimize the amount of

residual

> silicone that may be left at the implant site.3. Implant Rupture

and Gel

>

> http://www-

c.pbs.org/wgbh/pages/frontline/implants/corp/pkginserts.html

>

> (Statement from the Dow Corning Corporation, September 1995)

>

> > As new research on breast implants is discrediting accusations

linking the

> > devices to immune system disease, older accusations are being

recycled that

> > Dow Corning failed to disclose the complications involved with

breast implants

> > and breast surgery until " forced " to do so as a result of an

unfavorable

> > 1984 legal verdict. As a result, the critics maintain, women did

not have

> > sufficient information to make an informed decision.

>

> > Excerpts from Dow Corning's Package Inserts and Information

Sheets:

>

> These excerpts show changes through the years in Dow's package

inserts and

> > information sheets concerning silicone breast implants. The issue

of

> > 'Informed Consent' --whether or not women were informed of the

risks or

> > complications from silicone implants and how long they would last-

-is a central one in

> > the implant controversy.

> >

> > Dow Corning Cronin Technique for Implanting, Package Insert 1965

> >

> The possibility of tumor formation around synthetic implants in

animal

> experiments should be explained to patients in whom synthetic

material is to be

> considered.

>

> > Dow Corning Fact Sheet 1976 Fibrous Capsule Contracture

>

>

> > It has been recognized for many years that capsular contracture

occurs in

> > some augmentation mammoplasty patients.

> Hormones, gel " bleed " , silica, dust, talc, surgical procedure,

pocket size,

> fill levels, patient type, electrostatic charges, (WHAT ? ? ?

electrostatic

> charges? )

>

> Gel-filled silicone implants slowly " bleed " minute quantities of

silicone,

> which has been detected in the fibrous capsule. The presence of

this silicone

> does not correlate with the clinical hardness of the capsule.

>

> Dow Corning Suggested Surgical Procedure 1976, 1979, 1980Adverse

Reactions

>

> > Occasional complaints of excessive breast firmness and/or

discomfort caused

> > by fibrous capsule formation and shrinkage have necessitated

surgical

> > correction and have been noted in the medical literature ( how

often is

> > occasional ? )

> Be certain that the patient understands that following

implantation, abnormal

> squeezing or trauma to the breasts could conceivably rupture the

implants

>

>

> > Dow Corning " Facts You Should Know About Your New Look " , 1977,

1978, 1979

> Q. How long will the implants last?

> >

> > A. Based on laboratory findings and human experiences to date, a

gel-filled

> > breast implant should last for a lifetime. ( Didnt all the dogs

implanted

> > with implants die ? ? ) However, since gel-filled breast

implants have been

> > implanted since 1962, there is only approximately 20 years of

actual experience.

> >

>

>

> > Dow Corning package insert 1983 Note

> Calcification

> Reports of calcium plaques on or surrounding mammary implants have

been

> reported in a few cases. No evidence is presented in the literature

to link the

> prosthesis with calcification.13. Silicone migration

> Closed capsulotomy procedures may rupture the implant and

necessitate

> removal. Under severe force the envelope can rupture and silicone

gel can be forced

> out of the implant into natural body planes.The above mentioned

reactions

> should be discussed with and understood by the patient prior to

surgery.

>

> Dow Corning package insert 1985Possible Adverse Reactions and

Complications

>

> IT IS THE RESPONSIBILITY OF THE SURGEON TO PROVIDE THE PATIENT WITH

THE

> APPROPRIATE INFORMATION PRIOR TO SURGERY

>

> . Capsule Formation and Contracture

> >

> > The post-operative formation of a fibrous tissue capsule around

the mammary

> > prosthesis is a normal physiologic response to the implantation

of a foreign

> > object.

> Capsule formation occurs in all patients. However, each patient

capsule will

> vary in degree, ranging from thin and filmy to heavily thickened.

Contracture

> of a fibrous capsule may occur, independent of its thickness,

resulting in

> discomfort, pain, excessive breast firmness, a palpable prosthesis,

and/or

> displacement of the prosthesis. The medical literature documents

that correction may

> require intervention by the surgeon.

> There have been reports of suspected immunological sensitization or

> hyperimmune system response to silicone mammary implants. Symptoms

claimed by the

> patients include localized inflammation and irritation at the

implant area, fluid

> accumulation, rash, general malaise, sever joint pain, swelling of

joints,

> weight loss, arthralgia, lymphadenopathy, alopecia, and rejection

of the mammary

> prosthesis. Such claims suggest there may be a relationship between

the

> silicone mammary implant and the reported symptoms. Materials from

which this

> prosthesis is fabricated have been shown in animal laboratory tests

to have minimal

> sensitization potential. (All the animals DIED)

> However, claims from clinical use of the silicone prosthesis in

humans

> suggest that immunological responses or sensitization to a mammary

prosthesis can

> occur. If sensitization is suspected and the response persists,

removal of the

> prosthesis is recommended along with removal of the surrounding

capsule tissue.

> This procedure is recommended along with removal of the surrounding

capsule

> tissue. This procedure is recommended to minimize the amount of

residual

> silicone that may be left at the implant site.3. Implant Rupture

and Gel

> Extravasation

> Medical reports state more frequent intra-operative rupture occurs

with the

> use of a small incision for introduction of the prosthesis, as in

> trans-axillary insertion, or in submuscular placement of a

prosthesis. As reported in the

> literature, when an implant ruptures, gel may be released from the

implant

> envelope despite the cohesive properties of the gel. If left in

place,

> complications such as enlarged lymph nodes, scar formation,

inflammation, silicone

> granulomas and nodule formation may result. Possible further

migration of the

> silicone gel to other tissue as well as adjacent tissue may occur.

A limited

> preliminary study has been reported to the medical community that

in the presence of

> select bacterial infection at the site of a ruptured implant,

extravasated gel

> may be altered by the bacteria with a resultant decrease in

cohesivity of the

> gel. If true, there is greater potential for distant migration of

the gel. In

> the event that a ruptured prosthesis is suspected, and especially

if the area

> becomes infected, Dow Corning recommends removal of the envelope

and gel.

>

> The detector of small quantities of silicone in the tissue adjacent

to the

> intact, conventional gel-filled implant and in axillary lymph nodes

has been

> reported in the medical literature. There is no evidence of

metabolic products of

> this silicone bleed. Some cellular reaction around the implant may

be

> expected as normal foreign body response.16. X-ray Pre-Operative

and

> Post-Operative17. Calcification

> Physicians have reported calcification of the tissue surrounding

the implant.

>

> Occasionally, the gel has been observed to contain particles that

include

> material of varying size, texture, and coloration. Analysis have

revealed many to

> contain triglycerides, lipids, or steroid-type materials. These are

> postulated to slowly move through the silicone elastomer shell from

the surrounding

> tissues

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