Fw: Silicone Gel Breast Implants: Were Proper Disclosures Made?

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Thursday, July 12, 2001 3:07 PM

Subject: Silicone Gel Breast Implants: Were Proper Disclosures Made?

> ~~~ Thanks Janna ... never saw this one before. Posted on

> alt.support.breast-implant ~~~

>

> http://www.tabexperts.com/breast.html

>

>

> Silicone Gel Breast Implants:

> Were Proper Disclosures Made?

> P. , Ph.D., MBA

>

>

>

> Introduction: Silicone, a polymer of silicon, oxygen, and carbon, was

> invented in the late 1800's by Professor F.S. Kipping at Nottingham

> University. Little practical use was made of these materials until the

> 1940's when Corning Glass Works formed a working relationship with Dow

> Chemical Company (Dow-Corning Corporation) to develop many uses such as

high

> temperature-resistant lubricants, rubbers, antifoam, mold-releasing

> compounds, insulation, as well as medical devices.

> Silicone gel breast implants are medical device prostheses used to

> substitute for human breast tissue for purposes of augmentation or

> replacement following mastectomy. Implants consist of a plastic envelope

or

> shell containing a soft gelatinous mixture. The shell consists of a highly

> cross-linked silicone polymer while the gel contents embody linear

silicone

> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

> weights with less cross-linking than the shell material. Silicone gel

> implants were invented in 1963 for breast augmentation to replace the use

of

> silicone injections.

>

> Silicone gel breast implants were widely marketed and used over a

> thirty-year period until 1992 when the FDA banned them for lack of

> sufficient safety and efficacy data. The number of breast implant

operations

> in this time period is estimated to be between one and two million. In

1992,

> when sales were ceased, there were over 87, 000 breast implant surgical

> procedures of which 25, 676 (29%) were breast implant removal operations.

>

> Disclosure to Patients Issues Today, there is a great deal of controversy

> regarding certain physical characteristics of silicone gel breast implants

> versus what was revealed to or understood by patients as well as the

medical

> profession. There are at least six important product information issues

that

> should have been disclosed by the manufacturers in the package inserts

> accompanying the product.

>

> 1. Silicones have biological activity. Contrary to popular belief amongst

> plastic surgeons in the beginning, silicones were and are biologically

> active compounds.

>

> Issue: There are published reports and internal company documents from

> silicone breast implant manufacturers that reveal screening and discovery

of

> silicone compounds which exhibited pesticidal, antibiotic and hormonal

> activities.

>

> 2. Injected silicones caused problems. The potential danger of silicone

> compounds was published widely in the scientific literature revealing

> adverse reactions to silicone injections when used for augmenting the

human

> female breast.

>

> Issue: Despite much evidence, a correlation between silicone toxicity from

> direct injection with the possible silicone toxicity associated with gel

> bleed from implants was never addressed.

>

> 3. Gel bleed from implants was documented. Gel bleed is a phenomenon,

which

> describes the migration of silicone molecules contained in the gel implant

> through the permeable shell. The fact that gel implants exuded a " greasy "

> residue was well known by manufacturers and plastic surgeons.

>

> Issue: Historically, neither the patients, surgeons, nor the FDA were

> adequately informed about the gel bleed while it can be documented in

> company memos that gel bleed was known, discussed, and proposed to be

> studied at least 15 years before it was revealed in product package

inserts.

>

> Issue: The gel material leaking from the implants was not characterized,

and

> hence, posed an unknown health hazard to silicone gel breast implant

> patients.

>

> 4. Gel migration is described as the movement of silicone residues

released

> from silicone gel breast implants throughout the body being carried by

> phagocytic cells via the lymph system or by some other mechanism.

>

> Issue: Silicone fluids and gels have been known and observed to migrate

both

> in animals and humans as cited in company memos written and papers

published

> at least 15 years prior to being mentioned in product package inserts.

>

> 5. The chemical stability of silicone gel implants in biological systems

> should have been a critical factor when determining the suitability of

> implant formulations for long term use.

>

> Issue: There is evidence both from company documents as well as the

> scientific literature that shelf life or stability data were not given

> proper consideration in the manufacture of silicone gel breast implants.

>

> Issue: Long term suitability studies for breast implants in animals or

> stored on the shelf appear to be currently unknown or at least unpublished

> by breast implant manufacturers.

>

> 6. The information provided in package inserts for silicone gel breast

> implants was incomplete and sometimes incorrect. Such information

> accompanying regulated medical devices should be a fair and equitable

> representation of the safety and efficacy of the product.

>

> Issue: The fact that gel implants could bleed gel and that the gel could

> migrate through tissues from the site of implantation failed to be

mentioned

> in package inserts for more than 15 years.

>

> Issue: The fact that gel implants had a limited shelf life was not

addressed

> in package inserts for more than 15 years.

>

> Conclusion It is apparent that disclosure of critical information to

> patients regarding the physical characteristics of silicone gel breast

> implants was inadequate. Hence, patients were ill-informed when making

> decisions regarding the safety and stability of the products to be

implanted

> in their body.

>

>

>