(this is just to inform our costumers, not to generate or promote fear.)

News Report from Jan. 27, 2011

US federal health officials say they are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices which have been scrutinised for decades.

The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and the skin and has been reported in the scar tissue which grows around an implant.

The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.

The agency has learned of just 60 cases of the disease worldwide, among the estimated five million to 10 million women with breast implants.

The agency reviewed the scientific literature going back to 1997 along with information provided by international governments and manufacturers.

Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site.

The agency saw no difference in cancer rates between patients with saline versus silicone implants. There was also no difference between patients who got the implants for cosmetic reasons versus those who underwent reconstructive surgery after breast cancer.

Because the disease is so rare, FDA researchers suggested the issue may never be completely resolved.

“A definitive study would need to collect data on hundreds of thousands of women for more than 10 years. Even then, causality may not be conclusively established,” the agency said.

Still, the FDA said it is working with the American Society of Plastic Surgeons to register patients with the cancer and track them over time.

Breast implants are marketed in the US by Allergan Inc and Johnson & Johnson’s Mentor Corp. Those companies will be required to update the labelling for their products to reflect the cancer reports.

A handful of researchers have published papers on instances of the lymphoma in breast implant patients over the past three years, prompting FDA’s review.

Some research suggests bits of silicone can leak into skin and lymph node cells, triggering the cancer. Even saline implants include trace amounts of silicone to help them maintain shape.

The lymphoma is an aggressive form of cancer though it is often curable, according to experts. Treatments include radiation, chemotherapy and a bone marrow transplant, if the disease returns.

Reports of the cancer among women with breast implants have been reported anecdotally for years, according to Dr Jasmine Zain, a lymphoma specialist at New York University’s Langone Medical Centre.

“We’ve seen it from time to time over the years but this is the first time the FDA actually looked at all the case reports and made a statement,” Zain said.

The FDA pulled silicone breast implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.

But in 2006 the agency returned the implants to the market after most studies failed to find a link between silicone breast implants and disease.

The approval came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well conduct new decade-long studies of the safety of the devices in 40,000 women.

The FDA said the companies have continued to pursue those studies, though several of them have enrolled less than half of the patients needed to make them statistically useful.

Dr Diana Zuckerman said the studies “will be completely useless unless the FDA can convince the companies to do more to keep women in their studies”. Zuckerman’s group, National Research Centre for Women and Families, opposed the FDA’s decision to re-approve silicone implants.

Wells Fargo analyst Larry Biegelsen, who covers the medical device industry, said the negative media coverage over the issue could hurt implant sales.

“At this point, we do not expect breast implants to be removed from the market, but sales growth could be negatively impacted by the media coverage,” Biegelsen wrote in a note to investors.

I wanted to report my experience with Woman’s Miracle, the Natural Breast Enhancement Supplement. I took the pills for 2 months and then got pregnant.    So, I stopped taking them for now, and plan on resuming after the baby comes and I am finished with breast-feeding.  However, what I experienced in the 2 months that I took Woman’s Miracle, was added energy, fuller lips, clearer skin, an easier and milder monthly cycle, less anxiety (a feeling of calmness), improved moods, and the best part… fuller breast.  In the two months, my breast did not become GIANT, HUGE melons popping out of my chest, but they became fuller and perkier.  The recommended use, suggest 3-6 months and a 1 month maintenance.  I believe my results would have only gotten better had I had the opportunity to take them for a longer period.   Overall, I loved the way I felt and looked as I took Woman’s Miracle, and will definitely begin them again post-pregnancy!
Amy