Tag Archives: food and drug

Vos: Race for the Cocoa Butter not the cancer answer » Local News » The Free Press, Mankato, MN

— I eat a minimum of processed meats that contain nitrites.

I drink from a stainless steel water bottle instead of my old plastic one to avoid BPA leeching into my water.

I wash my pesticide-covered produce in vegetable soap.

I gave up saccharin soon after my high school girlfriends stopped having Tab belching contests behind center field at my hometown ball diamond.

I have a fan in my attic and a tube in my closet that removes radon from my basement.

I threw out my eczema cream when the brand I’d been using received a “black box” warning from the Food and Drug Administration.

I buy milk that doesn’t come from cows given growth hormones.

I gave birth, and I breastfed a relatively long time — not so long that my son asked in coherent paragraphs to be fed, but long enough for me to know he had a mouthful of teeth.

I pick out the bluest, reddest, orangest, greenest fruits and vegetables I can find.

And despite all of that action to avoid numerous cancers, apparently all I needed to know about breast cancer prevention was that I should have dug my bikini out of the museum and hit the tanning bed awhile ago. I could have avoided breast cancer surgery, radiation and gotten a bonus Malibu Barbie look. 

To illustrate the tanning-cancer prevention theory, the Paddlefish Days parade today in Madison Lake is to feature bikini-clad women who are marching to raise money for the Breast Cancer Natural Prevention Foundation, which advocates cancer prevention through ultraviolet light exposure. (I’m not sure how to break this to my friend who has melanoma.)

The parade whipped up lots of publicity, both because more than 450 women in bikinis were supposed to descend on the streets of Madison Lake to break a world record (about 40 were signed up late in the week) and because the cancer-prevention premise seems wacky. Call it The Race for the Cocoa Butter. (Please don’t sue me for copyright infringement, Susan Komen Race for the Cure people.)

my Mayo oncologist and all of the other medical experts I’ve seen in the last couple of years never mentioned ultraviolet light exposure as a good way to prevent cancer. after my breast cancer diagnosis, they surveyed me about my physical development, lifestyle, analyzed my blood, sent me to a genetic counselor, and talked about family history. But not once did they ask if I or any of my family members spent a lot of time in Australia or frequently visited tanning booths.

after I started a drug that is supposed to remove estrogen from my body, which is thought to feed cancer, my oncologist said I need lots of calcium and vitamin D to keep my bones strong. And along with fortified milk and certain foods, the sun is, indeed, a source of vitamin D. But he did not recommend soaking in the sun or in tanning beds for hours or mention anything about bikinis. I guess that’s why the Internet is such a good source for that extra medical advice. (Note to my 13-year-old son: yes, this is sarcasm. Now turn off the computer. I know that your headache is tied to the four ice cream bars you ate in an hour, not the brain tumor symptoms described on hurtslikeheck.com.)

The dermapathologist at the Mankato Clinic told The Free Press that science has never proven that a lack of vitamin D causes cancer. Dr. James Benzmiller went on to say that even if that link were established, he wouldn’t recommend tanning because there is no safe threshold for ultraviolet exposure. It’s a fact not a theory that UV radiation is cancer causing.

I’ve got a hunch that this claim that UV exposure prevents breast cancer is another one of those cancer myths that lurks around every corner. Sort of like the book I ran across by a panic-stricken woman who said breast cancer survivors should never touch a drop of alcohol again.

I’m going to pour myself a glass of antioxidant-pumped red wine and mull that over before I bury my bikini for good.

Kathy Vos is The Free Press day news editor. Call her at 344-6357 or email kvos@mankatofreepress.com.

Vos: Race for the Cocoa Butter not the cancer answer »
Local News »
The Free Press, Mankato, MN

Breast Augmentation Controversy – A Look at Silicone Implants

The most controversial topic connected to breast augmentation has to be that of silicone implants. Concerns were raised in years past regarding the safety of these types of implants which led to the use of them being restricted by the Food and Drug Administration (FDA) in 1992. For a certain number of years silicone implants were not used. It is important to note however that while no evidence was found to support the safety of this kind of implant no evidence was found to support the claims that it posed a risk to patients either.

In recent years silicone implants have been making a comeback and are now available once again for patients who wish to undergo breast augmentation surgery. if you are considering work done on your breasts to improve the appearance of them and to make them larger than you may wish to find out everything you can about silicone gel-filled implants. The potential dangers of these implants were greatly exaggerated.

Do your research on these implants before you decide to say yes to them. Talk to the surgeon who will be performing your procedure to have all of your questions answered. if you know any former breast augmentation patients then ask them- if you feel comfortable having this conversation- if they chose to have saline or silicone implants. Weigh the pros and the cons before making this very important decision about your body and your life.

A silicone implant can be described as being a silicone elastomer shell that is filled with a type of silicone gel. The consistency of the newest and modern silicone gel is thicker as well as more cohesive than the silicone implants that were used back in its controversial days.

The old silicone gel-filled implants for mammoplasty patients are such that if they had been cut into the gel would easily have oozed out of the shells that encased the implants. However with the latest and more advanced silicone gel implants the fill inside the implant is able to adequately maintain its proper shape. This is a positive aspect and shows how superior the new silicone gel implants are in relation to the older ones.

Implants made of silicone appeal to many women because they are natural to feel and have a softer way about them. The fact that they look and feel like natural breasts is a big selling point for those looking to have breast augmentation surgery. Cohesive gel implants offer a consistency with the silicone fill that encourages the implant to remain in its original shape. When it does then the risk of rippling is reduced. Your options when it comes to cohesive gel implants are many when it comes to heights, projections and sizes.

It cannot be emphasized enough that communicating effectively with your cosmetic doctor is essential. It is important for your peace of mind as well as for the success of the operation.

Breast Augmentation Controversy – A Look at Silicone Implants

“Feel Beautiful” Clinic Adds New Drug for Painless Breast Augmentation

San Diego, CA (PRWEB) May 08, 2012

Dr. Steve Laverson observes the most painful and difficult portion of recovery from breast augmentation, tummy tuck, and other cosmetic procedures is the first three days or so after the operation. Exparel® is the first long acting version of a proven, widely used local anesthetic, bupivacaine, and was recently approved by the United States Food and Drug Administration for infiltration of the surgical site during a procedure to keep the area numb, and diminish post surgical pain, for approximately three days. Clinical trials demonstrated that when Exparel® was injected into the area of surgery, patients experienced better post surgical pain control for days, and required less narcotics than patients who did not receive Exparel®. By decreasing narcotic use after surgery, narcotic related unpleasant side effects such as nausea, constipation, sleepiness, and abnormal mood should be less common. “The entire surgical experience will be improved, and return to work, play, parenting, and other activities should be quicker,” says Laverson.

Conventional anesthetic injection during surgery only lasts several hours. Alternatively, anesthetic pain pumps infiltrate local anesthetic for several days, but the cumbersome apparatus requires maintenance of a catheter into the surgical site. Exparel® utilizes Pacira’s proprietary Depofoam® drug delivery system, consisting of microscopic slowly dissolving vesicles that allow injected anesthetic to provide pain relief for up to 96 hours after surgery. To date, no adverse effects have been associated with the use of Exparel®. Dr. Laverson doesn’t plan to use Exparel® for facial plastic surgery because these procedures are less painful, and because paralysis of facial expression for several days could be problematic.

Dr. Steve Laverson is a diplomat of the American Board of Plastic Surgery, and has managed the Feel Beautiful Plastic Surgery Center in North San Diego County since 1993. Areas of specialized expertise include aesthetic enhancement of the face, breast, and body. Dr. Steve Laverson and Feel Beautiful Plastic Surgery have no financial interest in or professional association with Pacira Pharmaceuticals, inc.

Read the full story at http://www.prweb.com/releases/2012/5/prweb9480690.htm

“Feel Beautiful” Clinic Adds New Drug for Painless Breast Augmentation

BOTOX Cosmetic: 10-Year Anniversary of FDA Approval

BOTOX Cosmetic (onabotulinumtoxinA) Celebrates 10-Year Anniversary of U.S. Food and Drug Administration Approval. BOTOX Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

“When approved by the FDA in 2002, BOTOX Cosmetic changed the way that physicians could treat patients who were interested in improving the appearance of their vertical frown lines between the brows,” said David E.I. Pyott, Chairman of the Board, President and CEO, Allergan, inc.

“BOTOX Cosmetic has become the number-one neuromodulator in the United States and the number of patients considering talking to their doctor about treatment has more than quadrupled to 5.8 million since 2002.”

BOTOX secured its first FDA approval more than 22 years ago as a treatment for two rare eye muscle disorders, making it the first product of its kind approved in the world. In 2002, the same formulation with dosing specific to frown lines was approved under the name BOTOX Cosmetic.

Worldwide, approximately 30 million vials of BOTOX and BOTOX Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010). with approximately 2,500 articles on BOTOX and BOTOX Cosmetic in scientific and medical journals, BOTOX neurotoxin is one of the most widely researched medicines in the world.

“The FDA approval of BOTOX Cosmetic enhanced the practice of plastic surgery by providing plastic surgeons with a new treatment option for patients seeking to reduce the appearance of vertical frown lines between the eyebrows,” said Malcolm Z. Roth, MD, president of the American Society of Plastic Surgeons.

About BOTOX (onabotulinumtoxinA)

BOTOX is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX has a unique, protected molecular structure that stabilizes the core toxin in BOTOX from degradation. when injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX® is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months depending on the indication and on the individual patient.

BOTOX was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type a product approved in the world. Since its first approval in 1989, BOTOX has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide.

In the United States, BOTOX is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

In addition to its therapeutic uses, the same formulation of BOTOX with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX Cosmetic (onabotulinumtoxinA). BOTOX Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.HOT LUXURY LINKS

BOTOX Cosmetic: 10-Year Anniversary of FDA Approval

Pacira Pharmaceuticals, Inc. Reports 2011 Financial Results

PARSIPPANY, N.J., Mar 27, 2012 (BUSINESS WIRE) –Pacira Pharmaceuticals, inc. /quotes/zigman/3627855/quotes/nls/pcrx PCRX +0.21% today announced consolidated 2011 financial results, reviewed key 2011 accomplishments and reiterated that it expects to initiate the commercial launch of EXPAREL® (bupivacaine liposome injectable suspension) in the U.S. the week of April 9. EXPAREL was approved by the U.S. Food and Drug Administration in October 2011, and Pacira deployed a field force of 63 hospital specialists into the marketplace in January 2012.

“Last year was an important year for Pacira with our successful initial public offering and the approval of EXPAREL by the FDA with an indication for administration into the surgical site to produce postsurgical analgesia,” said Dave Stack, president and chief executive officer of Pacira. “We are pleased with the continued momentum created by our pre-launch efforts and remain on track to provide EXPAREL to the marketplace the week of April 9.”

EXPAREL Launch Supported by Targeted Commercialization Activities

— Extensive pre-launch program: EXPAREL data disseminated in more than 40 publications and presentations; interactions with more than 1700 potential customers through market research, advisory boards and strong presence at key medical meetings.

— Strategic partnerships: Programs in place with group purchasing organization partners and key opinion-leading hospitals to demonstrate the true cost of opioid-based postsurgical pain management.

— Phase 4 clinical program: Initiation of prospective Phase 4 clinical trials in surgical models of interest to our colorectal, plastic, general, urology and OB/GYN surgeon customers.

— Robust 2012 publication plan: More than 50 publications and data presentations planned for 2012.

— Ambulatory Procedure Code (APC) received: APC received from Centers for Medicare & Medicaid Services for payment of EXPAREL in ambulatory surgery.

— Focused field force: following mid-January deployment, the 63-person field-based specialty team has worked to initiate the formulary review process in targeted high volume hospitals to obtain access for EXPAREL.

“Our comprehensive pre-launch strategy in 2011, coupled with the January 2012 deployment of our dedicated hospital specialist field force and scientific team, has generated significant anticipated demand for EXPAREL in the marketplace,” said Taunia Markvicka, vice president of commercial operations.

Full-Year 2011 Financial Results

— Net loss for the year ended December 31, 2011 was $43.3 million, or $2.64 per share (based on 16.4 million weighted average shares outstanding).

— Total revenues for the year ended December 31, 2011 were $15.7 million compared with $14.6 million for the year ended December 31, 2010.

— Total operating expenses for the year ended December 31, 2011 were $54.8 million compared with $37.3 million for the year ended 2010. The increase was primarily attributable to an increase in selling, general and administrative expenses and the impairment of certain long-lived assets. Selling expenses increased due to the hiring of commercial personnel and activities supporting the commercialization of EXPAREL, and general and administrative expenses increased due to additional compensation-related expenses and other expenses associated with being a public company.

— Cash used in operating activities and for the purchase of fixed assets used in investing activities (“cash burn”) was approximately $37.2 million for the year ended December 31, 2011.

— Pacira ended 2011 with cash and cash equivalents, restricted cash and short-term investments of $77.5 million.

For the full-year ending December 31, 2012, excluding the impact of potential sales of EXPAREL, Pacira expects revenue to be between $23 and $25 million. Revenue expectations include anticipated DepoCyt® and DepoDur® supply and royalty revenue, collaborative licensing and development revenues resulting from DepoFoam®-based partnerships, and approximately $11 million in revenue resulting from the acceleration of the recognition of deferred revenue through the termination date of the EKR agreement on July 1, 2012.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call at 9 a.m. EDT today. The call can be accessed by dialing 1-888-396-2356 (domestic) or 1-617-847-8709 (international) five minutes prior to the start of the call and providing the passcode 91443763. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 50230808. The replay of the call will be available for two weeks from the date of the live call.

A live, listen-only webcast of the conference call can also be accessed by visiting the investors section of the Pacira website at investor.pacira.com. A replay of the webcast will be archived on the company’s website for two weeks following the call.

about Pacira

Pacira Pharmaceuticals, inc. /quotes/zigman/3627855/quotes/nls/pcrx PCRX +0.21% is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was approved for administration into the surgical site to produce postsurgical analgesia by the U.S. Food and Drug Administration in October 2011. EXPAREL and two other commercially available products utilize the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com .

about EXPAREL®

EXPAREL® (bupivacaine liposome injectable suspension) is indicated for administration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. Additional information is available at www.EXPAREL.com .

important Safety Information

EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater than or equal to 10 percent) following EXPAREL administration were nausea, constipation and vomiting.

please see the full Prescribing Information for more details available at www.EXPAREL.com .

Forward Looking Statements

any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL’s potential and the expected timing of commercial launch, expected 2012 revenues and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the planned commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the “Risk Factors” section of our final prospectus related to our public offering filed with the Securities and Exchange Commission on November 16, 2011, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. we anticipate that subsequent events and developments will cause our views to change. however, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. these forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Pacira Pharmaceuticals, inc. Consolidated Statement of Operations (unaudited) (in thousands, except share and per share amounts) three Months twelve Months Ended December 31, Ended December 31, ————————- ————————- 2011 2010 2011 2010 —————– ————– —————– ————– Revenues: Supply and royalty revenue $ 3,004 $ 1,525 $ 10,615 $ 11,345 Collaborative licensing and development revenue 1,229 666 5,074 3,217 ———- ——- ———- ——- Total revenues 4,233 2,191 15,689 14,562 ———- ——- ———- ——- Operating expenses: Cost of revenues 6,601 2,108 16,739 12,276 Research and development 2,636 3,674 14,873 18,628 Selling, general and administrative 6,694 2,419 20,159 6,367 Impairment of long-lived assets 3,019 – 3,019 – ———- ——- ———- ——- Total operating expenses 18,950 8,201 54,790 37,271 ———- ——- ———- ——- Loss from operations (14,717) (6,010) (39,101) (22,709) other (expense) income: Interest income 144 34 255 146 Interest expense (712) (1,382) (4,780) (3,959) Royalty interest obligation (8) 118 227 (930) Loss on early extinguishment of debt – (184) – (184) other, net 10 380 71 487 ———- ——- ———- ——- Total other expense, net (566) (1,034) (4,227) (4,440) ———- — ——- — ———- — ——- — Net loss $ (15,283) $ (7,044) $ (43,328) $ (27,149) == ========== == == ======= == == ========== == == ======= == Basic and diluted net loss per common share $ (0.72) $ (12.27) $ (2.64) $ (47.29) Weighted average common shares outstanding – basic and diluted 21,271,680 573,990 16,437,464 574,072 Pacira Pharmaceuticals, inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) December 31, December 31, 2011 2010 ————— —————— Assets Cash and cash equivalents and short-term investments $ 76,153 $ 26,133 Restricted cash 1,299 1,314 other current assets 5,197 3,608 Fixed assets, net 25,103 23,950 Intangibles and other assets, net 5,738 11,557 ——- ——- Total assets $ 113,490 $ 66,562 ====== ======= ==== ======= Liabilities and stockholders’ equity (deficit) Current liabilities $ 31,911 $ 16,322 Related party debt, including accrued interest – 49,795 Long-term debt and royalty interest obligation 20,074 24,865 other long-term liabilities 13,236 23,963 Stockholders’ equity (deficit) 48,269 (48,383) ——- ——- —- Total liabilities and stockholders’ equity $ 113,490 $ 66,562 ====== ======= ==== =======

SOURCE: Pacira Pharmaceuticals, inc.

Pacira Pharmaceuticals, inc. James S. Scibetta, 973-254-3570 or Pure Communications, inc. Dan Budwick, 973-271-6085

Copyright Business Wire 2012

Pacira Pharmaceuticals, Inc. Reports 2011 Financial Results

Chocolate Milk Recall for Alkaline Phosphatase Contamination

After Alkaline Phosphatase was found in a number of dairy products produced by the Oak Farms Dairy plant in Waco, Texas, the company initiated a recall of some chocolate milk products. the recall involves half-gallon plastic bottles of whole chocolate milk and half-pint paper cartons of whole chocolate milk and 1% chocolate milk, the U.S. Food and Drug Administration (FDA) just announced.

The presence of Alkaline Phosphatase was discovered in samples during routine testing. To date, Oak Farms Dairy has not received any reports of illness related to the affected product and is removing the product from the market. No other Oak Farms Dairy products are affected by this recall and, specifically, this recall does not impact any Oak Farms Dairy products in Dallas or Houston.

All packaging, regardless of size or type, is printed with a “BEST BY” or “SELL BY” date of March 22, 2011—printed as MAR 22 on paper half pints, 03/22/11 on plastic half gallons—and a plant code of 48-3302. Distribution was limited in scope; therefore, said Oak Farms Dairy, consumers should only be concerned with products carrying the following Individual Universal Product Codes (UPCs) and plant code 48-3302:

• ½-Gallon Plastic: Chocolate-WHOLE, UPC number 4127100724, date 03/22/11, plant code 48-3302.• ½-Pint Paper: Chocolate–WHOLE, UPC number 7002635006, date MAR 22, plant code 48-3302.• ½ Pint Paper: Chocolate–1%, UPC number 7002635007, date MAR 22, plant code 48-3302.

Alkaline Phosphatase is an enzyme naturally present in raw milk and that is not present in milk that has been sufficiently pasteurized. Records reflect, and subsequent testing confirms, that this issue was limited in scope to product processed during a two-hour window. the company has confirmed that all pasteurization equipment was performing to standard, and the Texas Department of State Health Services returned to the plant and found the pasteurizer, pressure differentials, and flow rates operating normally. the cause of the positive test result is under investigation.

Because the presence of Alkaline Phosphatase in milk suggests the milk may not have been pasteurized sufficiently, it is possible that pathogens were present in the raw milk to begin with, including Salmonella, Campylobacter, Listeria, and/or E. coli. because these pathogens may have survived, it is important to note that, if ingested, they could cause gastrointestinal infection and related complications of food poisoning.

The recall involves approximately 64,000 units of the affected product, which was distributed in Texas in San Antonio, Austin, Waco, Temple, Killeen, Hillsboro, Mexia, Wichita Falls, Lindale, and Jacksonville, as well as through numerous retail outlets, schools, and food service settings. the company is actively notifying customers and is in the process of retrieving the affected product.

Consumers in possession of this product should not consume it and should discard it. Consumers may return the product package to the place of purchase for a full refund or exchange. Oak Farms can be reached, toll-free, at 1-800-681-2249.

Chocolate Milk Recall for Alkaline Phosphatase Contamination

FAT ZAPPER: Should we dare to believe it really works?

SAN ANTONIO – Developers of a new device claim it can melt fat away without surgery. Recently approved by the Food and Drug Administration for safety, Zerona supposedly zaps fat with lasers. but does it really work?

KENS 5 followed Shirley Wood thorough the process to see the results.

Wood takes care of herself, exercising regularly and watching what she eats.  but keeping her weight down has become a struggle.

"I think just as you get older it’s harder to lose, especially in your midsection," said Wood.

Hoping to get rid of a few extra inches, Wood is turning to Zerona, the newest fat-fighting tool at the doctor’s office. She has a realistic goal for what Zerona can accomplish.

"I’m turning 50 next month and I’ve got a  goal of decreasing a dress size," Woods said.

Zerona is a non-invasive procedure that uses low-level lasers to contour the body and melt fat around the waist, hips and thighs.

"The laser makes the fat go into the circulation so you need to flush it out. You have to drink lots of water," explained plastic surgeon Dr. Michael Decherd, who is using Zerona on Wood.

The treatment consists of six sessions over two weeks. 

Cold laser beams circle the mid-section 20 minutes on the front, 20 on the back.

"You don’t feel a thing. It really is painless," said Wood as she underwent the treatment.

Recently approved by the FDA, Zerona guarantees you will lose three inches. If not, a patient can continue treatment until they do.

"People are absolutely loosing inches. That being said, it’s not surgery results. Basically clothes fit better," said Decherd.

And it’s not surgery prices. 

The average price for six Zerona treatments is $1,500.  Liposuction starts at $3,500. 

No down time also makes Zerona an attractive choice for some.

"It’s not invasive, that was important to me. I don’t think anyone likes to be put under," said Wood.  

Two weeks after she started, we were there for Wood"s last treatment where she was measured for results. Wood was pleasantly surprised.

Her waist dropped from 37 and a half inches to 33.  overall.she lost nine inches off her waist, hips and thighs.

"I’m so excited! Nine inches, that’s awesome," said Wood.  

And she met her birthday goal.

"these pants are almost a size smaller than I was wearing before. It’s almost too good to be true. but you were there for the measurements, and obviously  it’s not too good to be true.  It really does work," said Wood.

FAT ZAPPER: Should we dare to believe it really works?