Safety of Silicone Breast Implants (1999) / Chapter Skim
Currently Skimming:
Appendix B: Description of the Public Meeting
Appendix B: Description of the Public Meeting
Pages 488-504
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 488... ...
The public meeting particularly encouraged women and their families to share their accounts and experiences with silicone breast implants. Although the committee focused on the peerreviewed, published scientific literature for this report, the personal stories of women with implants provided a valuable context for its deliberations.
|
From page 489... ...
Written Statements This public participatory event was an opportunity for those with relevant information about the safety of silicone breast implants to advise and inform the committee. The IOM defined relevant information to include evidence on the strengths or validity of the science associating silicone breast implants with local or systemic health effects.
|
From page 490... ...
Due to time constraints, originally only 51 presenters were selected based on those best representing the array of topics. In mid June, IOM staff notified all individuals who wanted to provide oral statements of the date, location, contact information, and preliminary agenda for the meeting.
|
From page 491... ...
Sidney Wolfe Public Citizen's Health Research Group Susan Scherr National Coalition for Cancer Survivorship C Lin Puckett American Society of Plastic and Reconstructive Surgeons (ASPRS)
|
From page 492... ...
Committee Questions Panel III 10:20 a.m. Marie Pletsch, Plastic Surgeon Santa Cruz, California Mary McGrath Aesthetic Surgery Education and Research Foundation (ASERF)
|
From page 493... ...
Committee Questions Panel V 11:40 a.m. Donald Uhlmann University of Arizona Michael Raymond Harbut Wayne State University Jeffrey Brent University of Colorado Health Sciences Center/Toxicology Associates Douglas R
|
From page 494... ...
Garry Tulane University Medical School Merry Grant Victims of Induced Chemical Exposure (VOICE) and Women Injured by Medical Devices Outreach (WIMDO)
|
From page 495... ...
Dennis Deapen University of Southern California Catherine Dlugopolski Breast Implant Information Exchange Pamela G Dowd Magic Valley Breast Implant Survivors Brenda Glenn Mabelvale, Arkansas Steven E
|
From page 496... ...
Hasenour Kentucky Women's Health Network V Leroy Young Plastic Surgery Educational Foundation Steve Hoffman Niangua, Missouri Saul Puszkin Columbia University Medical Center 5:05 p.m.
|
From page 497... ...
Lacy Houston, Texas Diane Stevens Impart, Inc. Vesta Petersen Louisville, Kentucky Noreen Aziz National Cancer Institute, National Institutes of Health Peggy Pardo Breast Implant Information Exchange 5:45 p.m.
|
From page 498... ...
They affirmed their commitment to high-quality patient care and noted the benefits of silicone breast implants on quality of life and their positive influence on self image and level of functioning, particularly when used for reconstructive needs. Scientists, Physicians and Others Scientists, physicians, and others made presentations from a number of perspectives in support of, or in opposition to, systemic or other untoward effects of silicone gel-filled and saline-filled breast implants.
|
From page 499... ...
Consumer group and personal statements described silicone breast implants as the best alternative available for many reconstruction patients. Some statements stressed the value to women of having a choice and made a strong argument that such products should remain available to all patients.
|
From page 500... ...
In one particular statement, the original implants were saline, but due to the "sloshing" that is sometimes audible with these implants, they were later changed to silicone gel prostheses. Prior to explantation, many of these women described living with a multitude of systemic symptoms and illnesses, which were often the primary reason for implant removal since they were more debilitating than the local complications.
|
From page 501... ...
, hernia, and "restrictive pulmonary defect." As a result of their physical symptoms, many women underwent a variety of procedures and medical treatments. Explantation, mastectomy after explantation, complete hysterectomy, or salpingo-oophorectomy,
|
From page 502... ...
Many women felt that their physicians did not really obtain informed consent, since at best they recalled being told only of very small risks of complications associated with breast implants and most often being told that the implants were completely safe. The extent to which local complications were actually discussed is unclear based on the statements, but many women asserted that they were advised of few health risks associated with silicone gel or silicone shell implants by their physicians.
|
From page 503... ...
They reported that their children suffered with many of the same symptoms they themselves experienced, such as chronic fatigue and pain, and that these children were diagnosed with scleroderma, esophageal dysmotility, renal infection, rash, allergy, abnormal bone growth, upper respiratory tract infections, muscle weakness, leukemia, and precocious puberty. A consumer also reported that the milk bank would not accept breast milk donations from women with implants.
|
From page 504... ...
Some women reported getting regular mammograms for cancer detection, but others expressed fear of the pain of compression and of possibly rupturing the implant. The women made a number of recommendations to the committee which included the following: · unbiased research conducted without the involvement of the manufacturers, plastic surgeons, or any other groups with possible financial interests; · federal government oversight of the scientific research through a task force or special committee; · clinical research on the sick women, using not just their medical records, but performing physical examinations and laboratory tests to determine if they have classical diseases or commonalties that may suggest "a man-made disease by the manufacturers that only mimics others"; · revising informed consent forms to disclose the true incidence of local and systemic complications, and mandatory provision of a handbook or reference book for women considering implantation; · a national implant registry for data on types of implants, complications and complaints; · labels on implants that list all ingredients; · standardized medical implant manufacturing; and · screening for individual sensitivity to the chemicals in the implants.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.