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. Trouble to the Industry  ’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

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)  Trilucent TM ; Soy bean oil breast implant (Currently used in European countries but not yet approved by the FDA)