Day: 01/28/2011

Breast Implants Linked to Rare Cancer

Posted by

0


FDA Links Both Saline and Silicone Breast Implants to Lymphoma, but Risk “Very Low”
silicone breast implants

Jan. 26, 2011 — Women with breast implants “may have a very small but increased risk” of a rare form of cancer, the FDA today warned.

The FDA is aware of some 60 reports — 34 in the medical literature and others from doctors, regulators, and implant makers — of anaplastic large cell lymphoma (ALCL) in women with breast implants.

ALCL is a very rare disease that almost never starts in the breast. Yet an accumulating number of case reports suggest that ALCL in the breast may be a rare side effect of breast implants. ALCL is not breast cancer. It is a form of lymphoma that affects white blood cells called T cells.

The ALCL tumors linked to breast implants appear in the scar tissue that surrounds the implant, not in the breast itself. Although ALCL can be a deadly disease, case reports suggest that ALCL linked to breast implants is less aggressive — and more easily treated — usual ALCL.

Some 5 to 10 million women worldwide have received breast implants, yet only a very few have ALCL. It’s not yet clear whether the implants actually cause ALCL. Women without ALCL symptoms do not need to have their breast implants removed.

“Women not showing symptoms or problems do not need to change their health-care routine. ALCL has occurred in a  very small number of women compared to the millions who have had breast implants,” William Maisel, MD, MPH, chief scientist at the FDA’s device center, said at a news teleconference.

Most of the ALCL cases linked to breast implants have been in women who underwent implant revision operations due to a collection of fluid around the implant that would not go away. In the cases described in the medical literature, ALCL developed one to 23 years after implant — on average, eight years after the initial implant.

It’s not at all clear why implants might cause ALCL. One hypothesis is that silicone from the shell of the implant (saline implants also have silicone shells) might cause cancerous changes in T cells. But there is far too little evidence to know whether this is the case, Maisel said.

ALCL Symptoms

Women with breast implants who developed ALCL had persistent swelling and/or pain around their implant. Symptoms appeared long after the surgical incision had healed — usually years later.

Doctors who saw women with breast-implant-associated ALCL detected fluid collected around the implant. Some could feel a lump in the scar tissue around the implant.

Women with breast implants should not change their routine medical care. Instead, the FDA says, women with implants should:

  • Monitor their breast implants and contact their doctor if they notice any changes.
  • Get regular mammography screening.
  • Women with silicone-gel implants should get periodic MRI images to detect possible ruptures. MRI images should be taken three years after implant surgery and every two years thereafter.

Women considering breast implants should discuss all risks with their doctors. Felmont Eaves III, MD, president of the American Society for Aesthetic Plastic Surgery, notes that the risk of ALCL appears to be real — but vanishingly rare.

“Most plastic surgeons will go their whole career — and could go thousands of careers — without seeing one case,” Eaves tells WebMD.

Treatment for ALCL may include surgery, radiation, and chemotherapy. Although the evidence is sparse, there is some suggestion that ALCL linked to breast implants is far less dangerous than ALCL not linked to implants.

“There is some suggestion from the medical literature, and some belief in the scientific community, that ALCL associated with breast implants is a less aggressive disease,” Maisel says. “There is some thinking that just removing the implants, the fluid around the implants, and the capsule [of scar tissue that forms around the implant] may be sufficient.”

 

C-Reactive Protein Levels Don’t Predict Response to Statins

Posted by

0


Inflammation status, as measured by high-sensitivity C-reactive protein levels, doesn’t affect the relative benefits of statin therapy, according to a Lancet study.

Heart Protection Study researchers investigated whether the benefits of statin therapy were lessened in the face of low CRP levels. To do so, they randomized some 20,000 high-risk patients to 40 mg/day of simvastatin or placebo. Patients were stratified into risk groups based on their baseline CRP levels.

After 5 years’ therapy, all risk groups showed significant relative reduction in risk for cardiovascular events while taking statins — all around 25%.

The authors conclude that their findings don’t support the idea that “the beneficial effects of statin therapy are affected by baseline CRP concentration or, more generally, by inflammation status.”

A commentator generally agrees, but notes that patients on statins “who had low baseline CRP concentrations had the lowest rate of vascular events irrespective of their baseline LDL-cholesterol values.”

Source:Lancet

Stimulating The Brain’s Immune Response May Provide Treatment For Alzheimer’s Disease

Posted by

0


A new target for the prevention of adverse immune responses identified as factors in the development of Alzheimer’s disease (AD) has been discovered by researchers at the University of South Florida’s Department of Psychiatry and the Center of Excellence for Aging and Brain Repair.

Their findings are published online in the Journal of Neuroscience.

The CD45 molecule is a receptor on the surface of the brain’s microglia cells, cells that support the brain’s neurons and also participate in brain immune responses.

Previous studies by the USF researchers showed that triggering CD45 was beneficial because it blocked a very early step in the development of Alzheimer’s disease. In the present study, the researchers demonstrated in Alzheimer’s mouse models that a loss of CD45 led to dramatically increased microglial inflammation.

Although the brain’s immune response is involved in Alzheimer’s disease pathology, “this finding suggests that CD45 on brain immune cells appears critically involved in dampening harmful inflammation,” said study senior author Jun Tan, M.D., Ph.D., a professor of psychiatry and Robert A. Silver chair at the Rashid Laboratory for Developmental Neurobiology, USF Silver Child Development Center and research biologist for Research and Development Service at the James A. Haley Veteran’s Hospital.

The investigators also found an increase in harmful neurotoxins, such as A beta peptides, as well as neuron loss in the brains of the test mice.

“In short, CD45 deficiency leads to increased accumulation of neurotoxic A beta in the brains of old Alzheimer’s mice, demonstrating the involvement of CD45 in clearing those toxins and protecting neurons,” Dr. Tan said. “These findings are quite significant, because many in the field have long considered CD45 to be an indicator of harmful inflammation. So, researchers assumed that CD45 was part of the problem, not a potential protective factor.”

The next step is to apply these findings to develop new Alzheimer’s disease treatments, said Paula Bickford, Ph.D., a professor in the USF Department of Neurosurgery and senior career research scientist at the James A. Haley Veteran’s Hospital.

“We are already working with Natura Therapeutics, Inc. to screen for natural compounds that will target CD45 activation in the brain’s immune cells,” Dr. Bickford said.

Treatment Approaches to Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Posted by

0


Alone or together, {alpha}-blockers and antibiotics might help — but, if so, the effect is modest.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is characterized by pelvic pain or discomfort and urinary dysfunction, sexual dysfunction, or both for at least 3 of the prior 6 months; this diagnosis usually is made after a wide range of structural and infectious causes have been excluded. Many treatments have been suggested, but most treatment trials have been small and underpowered. In a meta-analysis of 262 randomized controlled trials of various treatments for CP/CPPS, investigators indentified 23 — with a total enrollment of about 2300 patients — that met inclusion criteria.

In pooled comparisons, either {alpha}-blockers (i.e., tamsulosin, doxazosin, or terazosin), antibiotics (mostly quinolones), or both in combination resulted in statistically significant but clinically modest attenuation of symptoms (e.g., total symptoms, pain, voiding, quality of life).

Comment: These results confirm the experience of most clinicians who find that patients get little benefit from any specific approach to CP/CPPS. The findings were statistically significant but barely reached a level considered to be clinically important. The authors also found some evidence for publication bias of positive studies of {alpha}-blocker benefit. The positive findings for antibiotics are somewhat puzzling because patients with infection were excluded, but quinolones do have anti-inflammatory and analgesic effects.

— Thomas L. Schwenk, MD

Published in Journal Watch General Medicine January 27, 2011