FDA hearings on silicone breast implants

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On April 11-13, 2005, the FDA's advisory panel on General and Plastic Surgery Devices will once again meet to review data on the safety of silicone breast implants. The panel will vote Tuesday on Inamed Corporation's application for approval, and on Wednesday on Mentor Corporation's application.

"This is the third time both companies have applied for FDA approval" explains Dr. Diana Zuckerman, president of the National Research Center for Women & Families. "The first unsuccessful effort was in 1991, so the companies have had more than enough time to study these products? Why have they provided no long-term safety data?"

Both companies applied for FDA approval again in 2002-3, but Mentor withdrew their application when Inamed's implants were not approved in January 2004. When the FDA refused to lift restrictions on the sale of silicone gel- filled breast implants at that time, the FDA explained their decision was based on concerns about rupture, unknown complication rates, and the long-term safety of silicone in the body.

Last week, the FDA publicly released their scientific review of the companies' applications. The reviews indicate that FDA scientists found that the industry data are insufficient to answer many of their concerns. In addition, the data reveal significant problems with the devices.


"It is difficult to reasonably predict the probability of rupture through year 10 with the available data." FDA Summary Panel Memorandum

  • The FDA's probability analysis, provides several estimates based on industry data. Assuming that implants, like other products, are more likely to break as they get older, the most realistic estimate indicates that three-quarters of implanted women will have at least one ruptured implant within a decade of receiving the devices. Specifically, these data estimate that 93% of breast cancer reconstruction patients should expect at least one broken implant, 38% of augmentation patients, and 66% of women who replace previous breast implants with new ones.

  • Danish studies suggest there would be at least 22,500 implant ruptures per year in augmentation patients, whether the implants were made by Inamed, Mentor, or another company.

  • Company data show a 23% risk of rupture for reconstruction patients during the first three years and over 3% for augmentation patients. Almost all were silent rupture, with implants breaking or leaking without women being aware of it.

  • If silicone implants were approved, the FDA review recommended MRIs every year or two so that patients would be warned about potential leakage.

  • Mentor did not provide completed 3-year data on rupture. Since many of their patients did not have MRIs after the first year of implants, the data are not comparable to Inamed, or useful for the FDA. Mentor Data, Core Study, IMD3-1

Silicone Leakage and Serious Complications

"The data are of limited value to address the local health consequences of rupture" because of the short follow-up..

  • Approximately one in four women have silicone leaking outside their scar tissue capsules, and silicone seepage increases over time.

  • When that happens, women are more likely to report breast hardness, fatigue and other auto-immune symptoms, and, perhaps, auto-immune diseases.

  • Within three years more than one in four cancer reconstruction patients and implant replacement patients require additional surgery (26.3 percent), as do one in 7 augmentation patients (15 percent) need a new operation to fix an implant problem.

  • Other problems include painful hardening of the breast, changes in nipple sensation, dying breast tissue, and other complaints.

Long-Term Safety

While the data submitted by the manufacturers did not provide evidence of long-term safety, other researchers have conducted studies that indicate increased risks:

  • National Cancer Institute researchers found that women with implants were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide, compared to other plastic surgery patients.

  • FDA scientists studied women who had silicone breast implants for at least six years, and found that women with extracapsular silicone leakage were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia. Extracapsular leakage was evaluated using an MRI.

  • Canadian study found that women with breast augmentation were more likely to be hospitalized compared to other women of the same age in the same communities, and augmentation patients also had more medical visits.

  • A study of Danish women who had breast implants for an average of 19 years found that augmentation patients were twice as likely to report fatigue, Raynaud-like symptoms, and memory loss and other cognitive symptoms, compared to breast reduction patients or women in the general population.

  • A National Cancer Institute study found a statistically significant increase in reported connective issue diseases among women with breast implants, but also found errors in self-reported diagnoses. For example, many women who reported having rheumatoid arthritis had osteoarthritis instead, according to their medical records.


  • Breast implants interfere with the detection of breast cancer. A study published in the January 2004 of the Journal of the American Medical Association (JAMA) found that mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.

  • After hearing the manufacturer's data at the 2003 October panel meeting, advisory panel chairman Dr. Thomas Whalen wrote a letter to the FDA dated October 31 where he noted that mammography was a key concern, writing that "[t]here is at least one facet of long-term danger that was established during the panel -- specifically the obscuration of surrounding normal breast tissue to mammographic detection of breast cancer."

  • At the FDA's October 2003 panel meeting on silicone gel breast implants, FDA scientist Dr. Lori Brown presented her research on mammography, stating: "Silicone gel is radiodense and obscures part of the breast during mammography. Implants also decrease the compressibility of the breast. Special techniques are required to image breast tissues when implants are present and these techniques require additional views, so increase exposure to radiation, time required for examination, and cost."

  • The American College of Radiology Standards requires additional views during routine mammography for women with implants. As a result, we can expect at least double the radiation dose to the breast tissue per mammogram and double the cost of annual surveillance mammography.

Toxic Chemicals

An article published in the Annals of Bioanalytic Chemistry reported alarmingly high levels of a dangerous form of platinum in children born to women with breast implants. Platinum is a known toxic chemical.

Public Testimony

From 8 am until approximately midnight on Monday, April 11, almost 200 men and women will testify about their views as patients, family members, scientists, health professionals, and advocates. "It's an open process, and we hope science will be the winner, as individuals let their voices be heard and hope that their personal and professional expertise will illuminate the data and influence the outcome," says Dr. Zuckerman.

Source: http://center4research.org/


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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