1. Silicone Implants Amit Misra Kim Helmer Srikesh Sridharan

2. Overview • Introduction • History • Material • Advantages • Disadvantages • Concerns • Dow Corning Case • Currently

3. Introduction • Polysiloxane or Silicone are inorganic polymers. • Silicone became popular in the 1960’s as a medical grade implant. • Silicone implants uses varied from medical conditions to personal well-being. • Medically, silicone used for artificial limbs, pacemakers and various other implants in the body. • Personal well-being, silicone is used for breast augmentation. Our project research generally concentrated on breast implants.

4. Introduction • Silicone implants comes as a sack of silicone elastomers, which is surgically implanted under the chest tissue. • Companies that produced silicone implants were Dow Corning, Bristol Meyers-Squid and Bioplasty. • Disadvantages of silicone were not realized by people until the mid 1970’s. • Leaking, rupture, and hematoma became common problems. • People were outraged by the side effects leading to major controversy.

5. History • In 1930’s, silicone was developed as a synthetic polymer. • In the late 1940’s, physicians began to inject silicone to smooth out wrinkles. • In 1962, Dr.Thomas Cronin and Dr. Frank Garrow, were the first physicians to insert silicone gel for breast implants in patients with breast cancer. • In the late 1960’s, Dow Corning developed the first generation of implants as a commercial product.

6. Material • Silicone has alternating silicon and oxygen atoms. • The three basic silicone forms used in implants are fluids, gels and elastomers. • Properties include chemical inertness, thermal stability and resistance to oxidation. • Silicone based polymers are made by polymerization of monomers, which are called silanes.

7. Material • Silicone fluids are usually linear chains of polydimethylsiloxane (PDMS) with a wide range of chain length and molecular masses. • Silicone elastomer’s are extensively cross-linked and contain little free PDMS fluid.

8. Reasons for selection • The chemical stability of the silicone structure. • Silicone’s ability to readily sterilize without the physical properties being destroyed. • Silicone’s flexibility due to its structure is very high. • Silicone’s mechanical endurance. Silicone’s are found to last for a long period of time.

9. Disadvantages • Leaking and Rupture • Capsular Contracture • Interference with mammography and cancer detection. • Calcium deposits. Most of these problems are not specific to silicones (polydimethylsiloxane).

10. Concerns • Breast cancer • Auto-immune diseases • Breast feeding None of these concerns have been medically proven.

11. Advantages • For women that have had breasts removed due to cancer and/or need reconstruction • Avoid wearing external prosthesis • To help forget about their health • To feel “whole” again

12. Advantages • Improve personal preferences and well-being • Improve image • Increase confidence • Can improve how a person thinks of themselves

13. Dow Corning • In the 60’s, they were the leading producers • Involved in studies to increase the reality of their product. • Responsible for safety studies on their implants

14. Federal Food and Drug Administration (FDA) • In 1976 proof of silicone implant safety was required • “Grand fathering” by the FDA

15. ’77 women won $170,000.00 ’82 women received 2 Million Dollars ’91 in Alabama won 5.4 Million Dollars CA women won 7 Million Dollars ruptured implants that caused pain Claimed to develop systematic autoimmune disease Symptoms of autoimmune disease Ruptured implant Trouble to the Industry

16. Dow Corning Files for Bankruptcy • In 1995 Dow Corning files for chapter 11 • 410,000 potential claims against them • Class action suit with about 400,00 clients • In min-1998 Dow Corning agreed to a $4.5 billion payment • In late ’98 a scientific panel agreed that there were no proven links of disease and implants

17. Currently • Silicone implants are available only through: • Adjunct studies • Investigational Device Exemptions studies (IDS) • Saline implants from Mentor corp. & McGhan Medical (only ones approved by the FDA) • TrilucentTM; Soy bean oil breast implant (Currently used in European countries but not yet approved by the FDA)