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Ashcraft & Gerel
LLP
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CLICK HERE FOR ANSWERS TO FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT THE
BANKRUPTCY JOINT PLAN OF REORGANIZATION, FROM THE BREAST IMPLANT
TORT CLAIMANTS COMMITTEE AND DOW CORNING CORPORATION
Silicone gel-filled breast implants have been manufactured and sold to women around the world since the mid 1960's. Initially, this product was targeted at women who were in need of reconstruction following mastectomy for breast cancer or cystic breast disease. In the mid-70's and 80's the market, as well as the number of implant manufacturers for both reconstruction and cosmetic purposes, exploded. Ever since silicone gel-filled breast implants first entered the market place, they have been the subject of much attention and recently the center of great controversy.
The History of Breast Implants and The Role of the FDA
Many assume that because silicone breast implants were on the market for a long time preceding the present controversy, they must have been safe and approved by the FDA. This assumption is incorrect. The regulatory framework for medical devices, which include silicone gel-filled and saline filled breast implants, did not play a role in the early development, marketing or labeling of this product. Because the use and sale of breast implants pre-existed regulations regarding other medical devices and prosthetics, breast implants were not subject to the rigorous regulatory process other medical devices are now put through.
In fact, in the mid-80's when questions began to arise with regard to the rupture rate of implants and the incidence of painful scar tissue development in the breast, the FDA requested that the industry provide safety data to support the continued use of their product in the market place. When the industry was unable to provide the requested information, some manufacturers took preemptive action removing their breast implants from the marketplace. The first such "voluntary" withdrawal from the marketplace involved polyurethane breast implants, such as, the Meme or Replicon implant.
In 1993, recognizing the vacuum that existed with regard to safety data for breast implants, the FDA proposed a moratorium on the use, sale and implantation of silicone gel-filled breast implants, except under very limited circumstances. This moratorium remains in place today, despite the efforts of the breast implant manufacturers to have the moratorium lifted. Significant questions remain today regarding whether breast implants cause autoimmune disease and a variety of other serious complications. The FDA maintains a World Wide Web site regarding the breast implant controversy located at The Food and Drug Administration's Breast Implant Home Page.
Since the early 1990's Ashcraft & Gerel has been working on behalf of its clients to ensure that manufacturers of these products disclose information about the health, safety and efficacy of these products. Some of the more frequently asked questions posed by our clients and by the general public are set forth below, followed by answers:
Essentially all breast implants on the market today are made of silicone. Silicone is a polymer called dimethylpolysiloxane. Silicone is used in several different forms in the construction of both silicone and saline breast implants. Very simply, in a silicone gel-filled breast implant, silicone is utilized to create both the shell of the implant (otherwise known as the elastomer), and silicone is also used to create the gel which fills the inside of the implant. While the components of each of these parts is generally the same, different manufacturing processes cause the elastomer to be more solid and the gel to be less solid.
All silicone gel-filled breast implants leak. It is widely
believed and scientific evidence
indicates that the phenomenon of gel bleed occurs in every
silicone gel-filled breast implant. Gel bleed is the process
by which silicone gel particles penetrate and pass through the
silicone
elastomer, which was designed to contain the gel. Once outside
of the elastomer it is free to migrate through out the body.
What happens once the gel particles escape the shell is the
subject of the controversy today.
Chances are that if you were implanted with silicone gel-filled breast implants and have not taken steps to protect your rights either in a state class action or the federal court class action your rights may be severely impaired or extinguished.
If you have been implanted with silicone gel-filled breast implants you should take immediate steps to inquire about your rights. You may email Ashcraft & Gerel to receive information on whether you still have rights and how to proceed. When e-mailing us be sure to provide the year of initial implantation, the manufacturer of your implants and a daytime telephone number at which you can be reached. If you do not know the manufacturer of your breast implants you should take immediate action, and request your records from your plastic surgeon. IT IS IMPERATIVE THAT YOU ACT NOW!
What is the status of the the Dow Corning bankruptcy?
Dow Corning filed for the protection of the United States bankruptcy laws in 1994, which it promptly received.As a result of Dow Corning having filed the petition for bankruptcy, the initial Global Settlement of breast implant claims was destroyed. The act of filing for bankruptcy caused all actions and claims against Dow Corning and its two shareholders, Corning, Inc. and The Dow Chemical Company, to be transferred to the United States District Court for the Eastern District of Michigan, where it has remained to the present. In accordance with bankruptcy law, Dow Corning was provided an opportunity to propose a Plan of Reorganization which would outline its plan for repaying its creditors and for compensating the victims of its products, including breast implants.
CLICK HERE FOR ANSWERS TO FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT THE
BANKRUPTCY JOINT PLAN OF REORGANIZATION,What is the Status of the Revised Settlement Program?
The Revised Settlement Program is a federal program set up by
the Courts to administer the claims of women with breast
implants manufactured by Bristol Myers Squibb, Baxter
Healthcare Corporation, McGhan Medical Company and Minnesota
Mining and Manufacturing Company (3M), to name but a few. The
Revised Settlement program or RSP, provides different levels
and avenues of compensation to women injured by silicone gel-
filled breast implants.
Based upon your date of implantation, your manufacturer, your
level of disability, your diagnosed disease and the time you
joined the program, different options for settlement and
participation in the plan are available. There is no
entitlement to an award based solely on the failure of a
product without a demonstrable physical illness.
Unfortunately, because benefits under the plan are so
factually sensitive, it is impossible to identify on this page
each scenario for recovery.
To date, participation in the class has not been closed. If you have not registered with the Claims Office you should do so at the earliest possible time, because it is not known how much longer participation in the Program will remain available.
Updates on the status of the breast implant litigation can be obtained on the Web .
The Claims Office is in the process of making payments to many claimants who have navigated the long road through the RSP and submitted approved claims for compensation.
Additional information about breast implants can be obtained at the Web site of the U.S. Food and Drug Administration, Center for Devices and Radiological Health.
