*F.A.Q.s
*ABOUT US
* BREAST IMPLANT INFORMATION
*SILICONE IMMUNE PROTOCOL
* IMPLANT RESEARCH
* ALTERNATIVE BREAST IMPLANTS
*LOCATE A PHYSICIAN
*LABORATORY TESTS
*GLOSSARY
*WHERE TO REPORT COMPLICATIONS OR ILLNESSES AFTER IMPLANTATION

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INFORMATIVE LINKS

HUMAN ADJUVANT DISEASE CORP.

DR. KOLB-PLASTIKOS

TEMPLE OF HEALTH

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DR. MYHILL- SILICONE DISEASES- UNITED KINGDOM

IMPLANT~INFO~NET

IMPLANT~INFO~NET FORUM

HUMANTICS FOUNDATION

SILICONE EDUCATION RING

INFO-IMPLANTS MAMMAIRES INC.

N.O.W.'S WORK ON BREAST IMPLANTS

TOXIC DISCOVERY NETWORK

CANDO

SALINE SUPPORT

SILICONE KIDS

AMERICAN AUTOIMMUNE RELATED DISEASES ORGANIZATION

SILICONE SURVIVOR'S HANDBOOK

BOOKS RELATING TO BREAST IMPLANTS

IMPLANT INFORMATION PROJECT

DR. MERCOLA

SILICONE/SALINE NEWS 2002

SILICONE/SALINE NEWS SPRING 2001

SILICONE/SALINE NEWS FALL 2001

CHIN AUGMENTATION OPTIONS

CHEEK AUGMENTATION OPTIONS

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  Human Adjuvant Disease Corp>

Several published reports have linked silicone implants to illnesses including fibromyalgia, chronic fatigue syndrome, multiple chemical sensitivity, neurological disorders, fungal infections, bacterial infections, carcinomas, and diseases resembling Sjögren's disease, mixed connective tissue disease, rheumatoid arthritis, lupus erythematosus, polymyositis, dermatomyositis, and scleroderma. Some physicians are unaware that silicone or saline-filled breast implants may cause systemic complications because these medical devices have been approved for marketing. Complicating this matter are the implant manufacturer funded research studies, which support claims of the companies that implant recipients are not more likely than the general population to develop the aforementioned illnesses. This is a controversial issue in medicine.

The number of men and women having augmentation procedures with silicone medical devices continues to rise in the U.S. Without understanding all of the local and systemic complications that can occur after any augmentation procedure with silicone, these patients are not able to give informed consent.


Breast Implants in the United States

The Food and Drug Administration did not regulate medical devices until 1976. Under the 1976 law, devices already in use such as saline-filled breast implants and silicone gel-filled breast implants were "grandfathered".The manufacturers did not have to demonstrate to the F.D.A. that the devices were safe at that time.

Saline-filled breast implants were on the market for nearly three decades in the U.S. before the FDA approved them in May 2000.Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for augmentation in women who are 18 and older. There is no age restriction for saline implants used for reconstruction.

Silicone gel-filled breast implants were removed from the U.S. market in April 1992. Since then the FDA has permitted a small number of women, who wanted silicone gel-filled breast implants for cosmetic purposes and women undergoing mastectomies, to receive the implants in a long-term study. On October 14th and 15th in 2003, the F.D.A. sought input from an Advisory Panel of experts on the data contained in the Inamed pre-market approval (PMA) for silicone gel-filled breast implants during an open public meeting. In a 9-6 vote, the Panel recommended approval of the Inamed PMA with conditions. Ultimately in January 2004, the Food and Drug Administration rejected Inamed Corp.'s bid to bring silicone gel-filled breast implants back on to the market.

Mentor Corporation submitted their silicone gel-filled breast implant PMA in December 2003. The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee reviewed applications submitted by Inamed Corp. and Mentor Corp. for marketing silicone gel-filled breast implants in April 2005. The advisory panel rejected U.S. sales of Inamed Corp.'s silicone gel-filled breast implants by a 5-4 vote. The following day, the Panel voted 7-2 in favor of allowing Mentor's application to be approved.

On Thursday, July 28,2005, the F.D.A. issued an approvable letter for Mentor’s application for silicone gel-filled breast implants. Inamed Corporation received an approvable letter from the Food and Drug Administration (FDA) for its silicone gel-filled breast implants on Sept. 21, 2005. The letters contained information regarding conditions that the companies needed to meet to obtain final FDA approval for marketing the implants in the U.S.

On November 17, 2006, the Food and Drug Administration (FDA) issued final approval to manufacturers Allergen Corporation (formerly Inamed) and Mentor Corp. for general marketing of silicone gel-filled breast implants to women of all ages for reconstruction purposes (e.g. cancer & trauma victims or those with breast abnormalities) and women 22 and older for augmentation purposes.The FDA has imposed a minumum age requirement for augmentation because breasts can continue to develop through a woman’s late teens and early twenties and because a young woman may not be mature enough to make a decision about potential risks. The FDA is requiring that Allergen Corporation and Mentor Corp. study 40,000 women for the next 10 years to assess potential health problems. The FDA has also recommended that silicone implant recipients have MRIs at regular intervals to detect ruptures that may be silent.


Breast Implants in the United Kingdom

Breast implants filled with either silicone gel or saline are available in the UK.

  • Saline-filled breast implants

  • Saline-filled breast implants consist of a silicone elastomer shell filled with sterile saline (salt water). Fillable and pre-filled implant models are available.

  • Silicone gel-filled breast implants
  • Double lumen implants containing a combination of silicone and saline fillers
  • Cohesive gel-filled breast implants

CE marked models of all of the above-mentioned implants are available with smooth or textured silicone elastomer shells.

  • Polyurethane-coated breast implants

  • These implants consist of a silicone elastomer shell filled with silicone gel. The shell is coated with a polyurethane foam which breaks down over time. Polyurethane-coated breast implants were removed from the UK market in 1991 but were reintroduced in April 2005. There have been no substantial changes to these implants since the 1990s.

About The Human Adjuvant Disease Corp.

The Human Adjuvant Disease Corp. is a non-profit organization dedicated to improving the diagnosis of systemic complications related to silicone implants, helping patients affected by complications, educating medical professionals and the public about implant related complications, and promoting research on silicone implants.

HADCORP. and IMPLANT~INFO~NET provide a support network for implant recipients with systemic complications and for their families. Visit the IMPLANT~INFO~NET FORUM for a support message board and live chat. Support by phone is also available upon request.

 
Membership

There is no fee to join HADCORP. If you would like to join this organization, please visit the following url:

http://www.freewebs.com/implants/patients.htm

  Update from CANDO

CANDO (Chemically Associated Neurological Disorders) is currently collecting symptoms and diagnoses in children born to mothers with breast implants. For more information please contact Marlene Keeling:

keeling.m@worldnet.att.net

 


Copyright 2004-2005, Human Adjuvant Disease Corp.
The information on this website is presented for educational purposes. It is not intended for medical diagnosis or treatment. If you have health related concerns please contact a physician. HADCORP. does not accept contributions or distribute funds.


 
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