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| The Breast Implant Research And Information Act |
November 27, 2001 |
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More than 200,000 women receive breast implants each year, and once again controversy is swirling around this issue of their safety. Last year, the Food and Drug Administration approved saline breast implants in spite of data from the manufacturers showing among other findings, that 73% of mastectomy patients reported severe complications within 3 years. Dr. S. Lori Brown recently released a study showing that women whose silicone gel implants had ruptured and leaked were twice as likely to report having Fibromyalgia as women whose implants had not ruptured. Dr. Louise Brinton, an epidemiologist at the National Cancer Institute, found an increased risk of brain and lung cancer among implant recipients when compared to other plastic surgery patients.
Reps. Roy Blunt (R-MO) and Gene Green (D-TX) have introduced the “Breast Implant Research and Information Act” in the house; along with Senator Barbara Boxer (D-CA) in the Senate. By addressing the need for more independent research and greater FDV oversight, the legislation will give women the information necessary to make informed choices about implants.
The Breast Implants Research and Information Act consists of three major components.
I. Expand NIH Research on Breast Implants
The bill directs NIH to conduct independent, scientifically valid research on both saline and silicone breast implants. The need for such research is clear:
- To date, most research on breast implants has been funded by implant manufacturers;
- Many studies have been methodologically flawed, combining women with saline and silicone implants, mastectomy patients with cosmetic augmentation patients, and women who have had implants in excess of 10- years with those who have had them for only three months;
There has NEVER been a large-scale study focusing exclusively mastectomy patients and the long-term effect of implants on their health.
II. Strengthen post Market Surveillance Activities Related to Saline Implants at the FDA
The FDA is instructed to conduct post market evaluations of saline implants, acting on recommendations made by the FDA’s General and Plastic Surgery Devices Panel. Strong FDA oversight is especially important given the circumstances surround the approval of saline implants:
- As noted above, 73% of mastectomy patients reported serious local complications following implantation. Complications included rupture, hardening, infection and chronic pain;
- With studies lasting only 3 years, the long term effect of saline implants is unknown;’
- At the time of approval, the FDA was conducting a criminal investigation into one of the implant manufacturers related to allegations of data manipulation in its breast implant trails. This investigation remains open.
III. Expand and Intensify FDA Activities relating to Silicone Breast Implants
The Commissioner of the FDA is directed to take concrete steps to ensure that women, particularly those participating in clinical trails of silicone implants, have accurate, current information about implants. Greater FDA involvement is essential because:
- Informed consent agreements are written by implant manufacturers;
- Informed consent agreements and package inserts prepared by manufactures have been shown to include outdated, inaccurate information;
- Women involved in clinical trails have had difficulty in reporting problems with their implants and with the trails themselves.
The Breast Implant Research and information Act is critical if women are to fully understand the impact of breast implants on their health.
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