Fw: Emailing: Silicone Implants... works for the FDA or could I be wrong??

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Silicone Gel Breast Implants: Were Proper Disclosures Made?

by 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.

About P. , Ph.D., MBA