Indoor Tanning Products

December 8, 2016

Several risks are involved with using indoor tanning products. For instance, if you use an indoor tanning booth or bed, you are exposing your body to UV (ultraviolet) radiation, which promotes skin damage, eye injuries, melanoma and other skin cancers.

Because of the gradual impact of UV radiation, it places children, adolescents and young adults at a higher risk for eye and skin conditions in their later years. The FDA is determined to minimize the damage of UV radiation caused by indoor tanning products by prohibiting the use of these products by people under the age of 18. Also, indoor tanning sites are required to provide literature about the possible risks associated with using an indoor tanning product and have the consumer acknowledge the awareness of such risks by signing an acknowledgment form.

The FDA is also considering another rule that will require makers of indoor tanning products and tanning sites to create more proactive strategies to prevent injuries from using these products.

Dr. Markham Luke, dermatologist and deputy office director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health tells us that using indoor tanning products at a young age (childhood and young adulthood) increases the potential to develop melanoma and other forms of skin cancer. Markham also states that several hundred youth each year in the US get injured from using an indoor tanning product.

The American Academy of Dermatology states that exposure to indoor tanning products make people 59% more likely to have melanoma than people who have never used an indoor tanning product.

Studies conducted by the Centers for Disease Control and Prevention (CDC) between 2003 to 2012 conclude that there are over 3,000 emergency room visits in the US alone due to indoor tanning product-related injuries. Interesting enough, over 400 of the patients were adolescents under the age of 18.

Things to Keep in Mind for those Still Planning on Using an Indoor Tanning Product

Now the FDA has taken steps to prevent injuries to minors who use tanning products. FDA-approved products will carry a disclaimer that prohibits the use of the tanning product by people under the age of 18. Indoor tanning products are required to have a visible, black-box disclaimer that people under age 18 should not use the product. Also keep these points in mind:

  • Being exposed too long (like near the maximum time for the tanning device) can cause sunburn. Since it takes from 6 to 48 hours to realize your skin is sunburned, it’s going to be hard to tell if you’ve stayed exposed for too long.
  • If you take medications or use certain cosmetics, it may make you sensitive to the sun (UV radiation actually), so consult your physician or pharmacist prior to using a tanning product.
  • Neglecting to wear protective goggles while doing indoor tanning can cause temporary or long-term eye problems.
  • Always follow the directions for the tanning product. If you have skin that easily burns or is hard to tan (or does not tan at all), then it is highly recommended you do not use an indoor tanning product.

Colorectal Cancer

September 9, 2016

In the U.S. last year, 136,000 people were diagnosed with colorectal cancer and 50,000 died of the disease according to data from the National Cancer Institute. This is the second leading cause of death in the U.S. It tend sot his some groups more than others. On minorities, the toll is very high according to director of FDA’s Office of Minority Health Jonca Bull, M.D. Populations that don’t get a lot of screening or get early treatment, die earlier. This impacts Hispanics, African Americans, Alaska Natives, and Indians. Early detection, treatment and referral can reduce the disparities in deaths from the disease.

Lives are Saved through Screening

Precancerous growths or polyps are the beginnings of colorectal cancer in the large intestine of the rectum. People that have signs of colorectal cancer or precancerous growths don’t always have any symptoms of the disease. Screening is important because suspicious tissue and growths can be removed before they turn into cancers.

How and When Should I get screened?

At age 50 you should get screen if you have any risk factors or developing colorectal cancer. People that are at a higher risk may need to get screened earlier on in life and may have to get more frequent screening. You can speak with your doctor to see what the best option for you. Several of the options include:

  • Colonoscopy – This is where a thin tube containing a light is inserted to look at the rectum and the colon for any growths, cancer, or abnormal tissues. You are sedated for this test. Routine screening needed every 10 years.
  • Flexible sigmoidoscopy – The doctor uses a thin tube and a light to look in the lower third of the colon as well as the rectum for abnormal tissues, growths or cancers. The thin tube may also include a tool which takes abnormal tissues for further examination. Routine screening is needed every 5 years.
  • Fecal blood test (gFOBTor FIT test) – You use a home kit provided by your physician and take a sample of your stool and take it to the lab. The sample is checked for blood and signs of cancer. If there’s blood, a colonoscopy is needed to determine the cause. Screening is needed once per year.
  • Stool (DNA test ) – you use a kit provided by your physician and provide a stool sample for the lab. It’s checked for genetic changes as well as blood. If there’s a positive test then you’ll need a colonoscopy. Routine screening is needed every three years.
  • Computed tomography colonography or “virtual colonoscopy” – This test is an X-ray imaging procedure which provided 3D and 2D views of the colon from the rectum as well as the lower end of the small intestine. There’s also some visualization of the small bowel. The colon is gently inflated with air through a small tube tip which is placed in the rectum. Routine screening is needed every 5 years.

Talk to your physician about regular colorectal screening procedures.

Pancreatic Cancer

June 14, 2016

Scientists are working on new therapies of pancreatic cancer. This is one of the deadliest cancers that impacts both men and women.

This is a disease that usually produces no symptoms at all until it’s in advanced stages. The only chance for a cure is with surgery, but most people aren’t candidates for surgery because the tumors that are relocated in the pancreas have spread. Most people that do have surgery will relapse and die from the disease.

In the past 20 years the FDA have approved three treatments for pancreatic cancer so patients can live longer. They are the drugs erlotinib in combination with gemcitabine, nab-paclitaxel in combination with gemcitabine, and plain gemcitabine

Abhilasha Nair, M.D., is an oncologist for the FDA who works on cancers of the colon, stomach, and digestive system. He says that the cancer starts in the pancreatic ducts. The KRAS gene found in tumor samples is mutated when examines in patients with pancreatic cancers.

Evasive and Deadly

The fourth leading cause of death in the United States is pancreatic cancer. On a yearly basis about 46,420 people are diagnosed with it and 39,590 die of pancreatic cancer according to the national Cancer Institute.

The cancer accounts for less than 3 percent of all new cancer diagnosis each year, but it’s deadly and aggressive. The survival rate after 5 years is only about 5%. If it’s not treated, a patient can die quickly. Surgery, radiation, and chemotherapy are the common options for treatments.

Jaundice, back pain, and unexplained weight loss are the symptoms that bring patients to a doctor’s office. Worsening diabetes, onset diabetes, vomiting, nausea, weakness, changes in appetite, and tiredness are other symptoms.

Targeting the Mutations

Scientists are looking at risk factors for pancreatic cancer. They look at pancreatitis, which is chronic inflammation of the pancreas as well as smoking. Pancreatitis causes chronic pain, abdominal pain, diarrhea, and loss of weight. They also look at genetic changes like BRCA1 and BRCA2 mutations, and longstanding diabetes. They also examine Lynch syndrome which is an inherited syndrome that increases risk for various cancers.

Scientists are working on drugs that target the KRAS mutation which is found in pancreatic tumors. KRAS is very evasive so finding the right drug to target the mutation would be a breakthrough in the treatment. More needs to be learned about the mutation so it can be overcome. Scientists are looking at the cells deep in tumors to see why pancreatic cancer is so resistant to chemotherapy drugs.

Male Breast Cancer

January 29, 2016

Breast cancer is usually associated with women as we think of the gear and pink ribbons which are sold to support awareness and research, but men get it too in rare cases.

The FDA doesn’t have good clinical trial date on treatments for make breast cancer since it’s so rare. Medical oncologist and breast cancer scientific lead at FDA’s Office of Hematology & Oncology Products Tatiana M. Prowell, MD says we treat men the same way as we do women for breast cancer.

In the historical sense, men are excluded from breast cancer trials. She stated that the FDA is encouraging drug companies to include men in their breast cancer trails unless they have some sort of scientific reason to exclude them. The number of men in any trial is always small because it’s a rare condition in men. There still needs to be information on the disease in men because it’s better than no information at all.

The Treatment of Male Breast Cancer

Treatment for male breast cancer is similar to that of women as there’s removal of the breast or mastectomy. In other cases there’s radiation, chemotherapy, lumpectomy, hormone therapy, and targeted therapies.

The treatment date for men is based largely on the trials that were conducted on women or are retrospective data from several men that were treated over time. There’s no high-level evidence or randomized trials for breast cancer treatment for males, says Prowell.

One drug called tamoxifen is a selective estrogen receptor modulator (SERM) and a hormonal drug treatment used. It inhibits aromatase inhibitors and estrogen receptors so the production of estrogen is blocked from testosterone and other androgens

For women that are postmenopausal aromatase inhibitors are used as a first-line treatment for any early stage breast cancers and tamoxifen is regarded as an alternative treatment. In men this is the opposite as aromatase inhibitors don’t work as well. In men tamoxifen is given first and aromatase inhibitors are the alternative treatment.

For men that have positive lymph nodes, cancer that has spread, or larger tumors, they receive chemotherapy as well as hormonal treatment just like women do. Men that have tumors which are HER2-positive usually get the antibody trastuzumab as it targets HER2 like it does in women. Men with breast cancer need genetic counseling according to Prowell.

Men also have another difference as they are not referred to a genetic counselor automatically if they have mutations like BRCA-1 or 2. These are “tumor suppressor genes” which allow breast cancer and other forms of cancer to develop when they don’t function normally. Women with certain characteristics or family history like having triple-negative breast cancer or being young are the only ones usually recommended for genetic testing.

In men African America men are more likely than white men to have tumors in the advanced stage or to get triple-negative cancers. They have tumors which have fewer treatment options or are likely to reoccur.

Rates of Skin Cancer

October 11, 2015

Basal cell carcinoma, melanoma, and squamous cell carcinoma are the three main types of skin cancer. Melanoma is less common, but dangerous and aggressive.

Skin cancer rates are rising in the United States. In 2014 the National Cancer Institute estimates that:

  • There will be 76,100 reported new cases of melanoma as well as 9,710 deaths.
  • There will be 2 million reported new cases of non-melanoma skin cancer with less than 1,000 deaths.

In our cells is where cancer starts. When cells are damaged or grow old, they usually die and we have new cells that replace them. In the case of cancer, new cells will grow when they aren’t needed and damaged or old cells don’t die when they should die which forms a tumor (mass of tissue). Skin cancer is able to spread throughout the body and invade otherwise healthy tissues.

There are treatments to remove skin cancer, but this depends upon the type of cancer and the stage that it’s in. The FDA had only 5 drugs approved before 2011 for the treatment of melanoma.

Most of these drugs shrank the tumors and were standard chemotherapy drugs, but they weren’t very effective with only a positive result in 15% of patients according to FDA oncologist Patricia Keegan, M.D. She stated that many people who took the drugs didn’t get a lot of benefit from them.

The FDA has approved one treatment combination and two melanoma drugs since 2011. Mekinist (trametinib) in combination with Tafinlar shrank tumors in clinical studies for about half of patients. The other drugs were Tafinlar (dabrafenib, and Zelboraf (vemurafenib). Patients using the new drug Yervoy (ipilimumab) and Zelboraf patients live longer using these drugs than if they got just chemotherapy according to Keegan.

New Treatments for Skin Cancer

One new class of immune therapy drugs that patients with melanoma are using is Yervoy. These patients have melanoma which can’t be removed by surgery or limited to certain gene mutations. The cytotoxic T-lymphocyte antigen (CTLA-4) molecule is blocked by the drug. It helps the body, target, recognize, and attack cells which have melanoma tumors. For over 100 years according to Keegan, scientists have been trying to gain this ability.

Keegan says that there has been a lot of experience with tumor vaccines and the hope was that they would attack the foreign bacteria, but most of these had been unsuccessful until now.

The drug Yervoy doesn’t attack the tumor directly. The drug helps the white blood cells of the body recognize tumor cells so they can be rejected by the body.

Mekinist, Tafinlar, and Zelboraf, are personalized drugs that treat patients with melanoma tumors with the BRAF V600E gene mutation. The drugs work to keep tumors from growing by blocking the BRAF gene which has been mutated.

Erivedge (vismodegib) is the first FDA drug approved to treat metastic basal cell carcinoma. This is a serious cancer for a small percentage of the population. Tumors on the face, nose, eyelid, and head are difficult to cut out for doctors or impossible and this drug helps treat these tumors. A rare form of skin cancer called Gorlin syndrome can impact many parts of the body and these individuals are vulnerable because their cancer can spread or return so this drugs helps.

Should I get breast implants? Are there alternatives? Will they need to be replaced?

And if you decide to get implants, there are even more questions. Saline or silicone?  What style? How much monitoring is needed?

Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.

FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.

A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.

FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.

More Risks of Breast Implants

Silicone implants sold in the U.S. are made with medical-grade silicone.  These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:

  • additional surgeries
  • capsular contracture—scar tissue that squeezes the implant
  • breast pain
  • rupture (tears or holes in the shell) with deflation of saline-filled implants
  • silent (without symptoms) rupture of silicone gel-filled implants

FDA experts suggest five things women should know about breast implants.

1. Breast implants are not lifetime devices. The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH).  “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”

2. Research products.  Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.

3. Communicate with the surgeon.  Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement).  Many women undergo reoperation to change implant size.  To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

4. Learn about long-term risks. Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

5. Monitoring is crucial. FDA recommends that women with breast implants:

  • promptly report any unusual signs or symptoms to their health care providers, and
  • report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.

Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.  Insurance may not cover these screenings.

Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.

Breast Implants

February 11, 2011

After an intensive review of known cases of a rare form of cancer in breast implant recipients, the Food and Drug Administration says women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.

FDA scientists reached that conclusion after examining scientific literature that focused on cases of ALCL in 34 women with breast implants, as well as information from agency reports, international regulatory agencies, scientific experts, and breast implant manufacturers.

But with an estimated five to 10 million breast implant recipients worldwide, agency experts say the known ALCL cases are too few to say conclusively that breast implants cause the disease. FDA believes there are about 60 of these ALCL cases worldwide, though that number is difficult to verify because not all of them were chronicled in scientific publications and some reports may have been duplicated.

In an effort to gather more information, FDA and the American Society of Plastic Surgeons are establishing a registry of ALCL patients who have breast implants. FDA scientists hope the registry yields enough information to better understand what the risks for developing ALCL are for women with breast implants.

Although the risk is quite small, FDA wants women to be aware that there have been reports of ALCL occurring around saline and silicone gel-filled breast implants. In the cases reported, ALCL was typically diagnosed years after the implant surgery. In most of these cases, the women were diagnosed after they observed changes in the look or feel of the area surrounding the implant.

Anyway this is another reason to think about All-natural Breast Enhancement Pills instead of risky breast surgery.