Silicone Implants Amit Misra Kim Helmer Srikesh Sridharan

Silicone Implants Amit Misra Kim Helmer Srikesh Sridharan

Overview ¬ Introduction ¬ History ¬ Material ¬ Advantages ¬ Disadvantages ¬ Concerns ¬ Dow Corning Case ¬ Currently

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.

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.

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.

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.

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.

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.

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

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

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

Advantages ¬Improve personal preferences and wellbeing ¬Improve image – Increase confidence – Can improve how a person thinks of themselves

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

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

Trouble to the Industry ¬ ’ 77 women won - ruptured implants that $170, 000. 00 caused pain ¬ ’ 82 women received - Claimed to develop 2 Million Dollars systematic autoimmune disease ¬ ’ 91 in Alabama won - Symptoms of autoimmune disease 5. 4 Million Dollars - Ruptured implant ¬ CA women won 7 Million Dollars

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

Currently ¬ Silicone implants are available only through: – Adjunct studies – Investigational Device Exemptions studies (IDS) ¬ Saline implants from Mentor corp. & Mc. Ghan 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)