By Steven ReinbergHealthDay Reporter Latest Cancer News
TUESDAY, July 24 (HealthDay News) — those who bronze themselves in tanning beds face a 20 percent increased risk of skin cancer, and that raised risk reaches 87 percent if they start before they are 35 years old, new research indicates.
The European study also estimates that one in every 20 cases (5.4 percent) of the most lethal form of skin cancer, melanoma, can be attributed to tanning bed use.
“Indoor UV tanning devices are real carcinogenic devices, and people should be advised not to attend indoor tanning parlors or to buy them for private use,” said lead researcher Philippe Autier, director of the International Prevention Research Institute in Lyon, France.
The U.S. Food and Drug Administration is considering a ban on tanning beds for anyone under the age of 18. Bans are already in place in Brazil and new South Wales and the idea is gaining popularity in France, Autier said.
Study co-author Mathieu Boniol, who is also from the International Prevention Research Institute, added that “as the use of these devices produces no positive effect to health, it is now in the hands of policy makers to decide how to manage, minimize or remove this risk.”
The report was published online July 24 in the BMJ.
To determine the relationship between tanning beds and skin cancer, the researchers analyzed 27 studies published between 1981 and 2012. In all, they identified more than 11,000 cases of skin cancer.
This process, called a meta-analysis, attempts to find patterns across several studies to uncover connections between unrelated research.
Of the almost 64,000 new cases of melanoma in Western Europe each year, more than 3,400 can be blamed on tanning bed use, the researchers calculated. Tanning bed use is also estimated to cause 800 deaths from this deadly cancer annually, the team added.
Since the use of tanning beds is relatively new and there is need for more research, the risk might be even greater, the researchers noted.
Dr. Jeffrey C. Salomon, an assistant clinical professor of plastic surgery at Yale University School of Medicine, said that “this study validates the previous studies and adds new risks to the ever growing knowledge of the downside of tanning beds.”
Parents should not only be concerned about their children using tanning beds, they should avoid using these devices themselves, he said.
“Tanning beds are worse than the sun for risk of melanoma based on these results,” Salomon said. “The risks from tanning beds are real, the untoward results can be dire, and the ultimate solution may require total prohibition.”
Not everyone agrees, however. John Overstreet, executive director of the industry group the Indoor Tanning Association, took exception to the findings.
One cannot compare tanning in Europe to the United States, he said. “Commercial tanning salons in the United States are a different matter altogether,” he said.
“The United States Food and Drug Administration has conducted tests to determine the amount of ultraviolet radiation required to burn persons with a variety of different skin types, and requires that all tanning equipment used in the United States carry labels specifying the recommended exposure times for each skin type, which have been calculated to prevent burning,” Overstreet explained.
Enforcement of the FDA recommendations is left to the individual states, he noted.
“Most states have strict enforcement, requiring on-site records to be kept of each customer session listing name, date of session, skin type, type of equipment used, and length of exposure, so that state inspectors can assure compliance with regulations. Burning of customers in these states is virtually nonexistent,” Overstreet said.
SOURCES: Mathieu Boniol, Ph.D., Philippe Autier, M.D., M.P.H., director, both International Prevention Research Institute, Lyon, France; John Overstreet, executive director, Indoor Tanning Association, Washington, D.C.; Jeffrey C. Salomon, M.D. assistant clinical professor of plastic surgery, Yale University School of Medicine, new Haven, Conn.; July 24. 2012, BMJ, online
WASHINGTON (AP) — Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.
The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. but recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.
While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.
“I do not use metal-on-metal hips, and I can see no reason to do so,” said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.
For decades nearly all orthopedic implants were coated with plastic or ceramic. but in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.
But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. that information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.
The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.
About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J’s recall of 93,000 metal hips in 2010.
FDA’s experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. however, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals
For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.
If the FDA ultimately follows the group’s advice, U.S. recommendations would be less involved than those already in place overseas.
Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.
FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.
“The truth is there are different types of hips and different types of patients,” said Dr. William Maisel, FDA’s chief scientist for devices, in an interview last week. “Understanding the characteristics of patients who experience adverse events is very important.”
Women and overweight people are among the groups that are more likely to have an implant failure.
With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.
FDA scientists say the studies will help “fill in the blanks” on a number of scientific questions, including the long-term effects of metal particles.
But public health advocates say it could take a decade before that information is available.
“Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical,” said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. “If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”
IRVINE, Calif., Apr 13, 2012 (BUSINESS WIRE) –Allergan, Inc. /quotes/zigman/217110/quotes/nls/agn AGN +0.48% announced today that April 15, 2012 will mark the 10-year anniversary of the U.S. Food and Drug Administration’s (FDA) approval of BOTOX® Cosmetic (onabotulinumtoxinA) to improve the look of moderate to severe frown lines between the eyebrows in patients age 18-65.
“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.(1, 2”)
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.
“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.
In the decade since BOTOX® Cosmetic was approved, aesthetic specialty physicians — which include dermatologists, oculoplastic surgeons and facial plastic surgeons — have developed extensive experience in the art and science of administering BOTOX® Cosmetic to yield predictable results for their patients. these physicians have performed approximately 11 million BOTOX® Cosmetic treatment sessions since 2002 and have also contributed to the extensive clinical database demonstrating the safety and efficacy of the drug.
“The approval of BOTOX® Cosmetic in 2002 dramatically changed our ability to treat our patients by giving them an effective option to treat the appearance of moderate to severe vertical frown lines with a minimally invasive procedure,” said Susan Weinkle, MD, president of the American Society for Dermatologic Surgery. “BOTOX® Cosmetic has become more accepted by the public, and this treatment has brought more patients into aesthetic practices to learn about other treatments available.”
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.
In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan’s clinical trials.(3) 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).(4) With approximately 2,500 articles on BOTOX® and BOTOX® Cosmetic in scientific and medical journals,(5) BOTOX® neurotoxin is one of the most widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
— to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease who still have leakage or experience too many side effects after trying an anticholinergic medication.
— to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
— to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
— to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
— to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
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).
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to treat increased stiffness in upper-limb muscles other than those in the elbow, wrist, and fingers, or to treat increased stiffness in lower-limb muscles. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX® Cosmetic:
— Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
— Spread of toxin effects. the effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. if this happens, do not drive a car, operate machinery, or do other dangerous activities
there has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, urinary incontinence in adults with overactive bladder due to neurologic disease, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.
do not take BOTOX® or BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® or BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
the dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. these include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® or BOTOX® Cosmetic.
Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for upper limb spasticity.
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.
Human albumin and spread of viral diseases. BOTOX® and BOTOX® Cosmetic contain albumin, a protein component of human blood. the potential risk of spreading viral diseases (eg, Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; pain or burning with urination, frequent urination, fever, have problems emptying your bladder on your own and are being treated for urinary incontinence, are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. using BOTOX® or BOTOX® Cosmetic with certain other medicines may cause serious side effects. do not start any new medicines until you have told your doctor that you have received BOTOX® or BOTOX® Cosmetic in the past.
especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For BOTOX® and BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide click here.
about Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. from our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
Forward-Looking Statements
this press release contains “forward-looking statements,” including the statements by mr. Pyott, Dr. Roth and Dr. Weinkle, and other statements regarding the safety, effectiveness and adverse events associated with BOTOX® Cosmetic. these statements are based on current expectations of future events. if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan’s expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning the above-referenced risk factors and other risk factors can be found in press releases issued by Allergan, as well as Allergan’s public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s 2011 Annual Report on Form 10-K. Copies of Allergan’s press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714-246-4636.
(1) BOTOX Cosmetic Quantitative Consumer Segmentation 2002, Pg 10 (2) Allergan data on file; 6MM BOTOX® Cosmetic Considering, Pg 1 (3) Allergan data on file; Medical Affairs (4) Allergan data on file; Global Regulatory Affairs (5) Allergan data on file; Global Literature & Information Services
These statements have not been evaluated by the Food and Drug Administration. Isagenix products are not intended to diagnose, treat, cure, or prevent any disease. the weight-loss testimonials presented apply only to the individuals depicted, cannot be guaranteed, and should not be considered typical. An unpublished 2008 university study showed a statistically significant weight loss of seven pounds during the first Isagenix nine days of the Cleansing and Fat Burning System. this website is operated by an independent Isagenix distributor.
Safety Disclaimer: if you are pregnant, nursing, diabetic, on medication, have a medical condition, or are beginning a weight control program, consult your physician before using Isagenix® products or making any other dietary changes. Discontinue use if allergic reaction occurs
Weight Loss Disclaimer:Weight-loss results may vary. in a recent study, participants averaged a weight loss of 7 pounds at the completion of their first Isagenix® 9 Day Program. Always consult your physician before making any dietary changes or starting any nutrition, weight control or exercise program.
Representative Edward Markey (Democrat) continues with his fight against bisphenol A—BPA—by introducing a bill banning the use of the hazardous chemical substance in food and drink containers, said The Boston Globe.
Markey’s bill, noted The Boston Globe, seeks to ban BPA in all reusable containers as well as in the plastic lining of canned foods and disposable containers and to mandate that the U.S. Food and Drug Administration (FDA) look at other substances in beverage and food containers, limiting use if the agency finds that they present a health risk.
“Feeding time for babies should be laced with love not laced with chemicals. Parents have enough to worry about without wondering if the bottles they use to feed their children are safe or if the can of formula they have warmed up is harmful to their health,” Markey said in a statement, quoted The Boston Globe. “This legislation will help keep BPA out of our bodies while also ensuring that all food and beverage containers are free from dangerous chemicals,” Markey added.
During Congress’s last session, The Boston Globe explained, the House passed a food safety bill containing the Representative’s provision concerning the FDA’s study of BPA; however, that provision was removed from the Senate’s version.
Several countries—Canada, France, and Denmark—have banned BPA in baby bottles and several states and entities limit the toxin’s use.
Trade group, the American Chemistry Council’s Polycarbonate/BPA Global Group, not surprisingly disagreed with legislation restricting the chemical saying, “Regulatory agencies around the world, including FDA, have evaluated the science and support the safety of BPA in materials for food contact products, including products intended for use by children,” said Steve Hentges, quoted The Boston Globe.
In fact, hundreds of studies have linked BPA to toxic injury and life threatening ailments, including cardiovascular disease, intestinal problems, brain cell connection interference, increased risks of reproductive and immune system diseases and disorders, problems with liver function testing, interruptions in chemotherapy, and premature puberty. we have also long written about BPA’s links to PCOS, female fertility issues, erectile dysfunction, and male sexual problems.
Most recently, in response to mounting consumer concern and what Sustainable Business described as “Congressional inaction,” legislators from 30 states and the District of Columbia announced legislation to protect Americans from dangerous chemicals, including BPA. although industry has funded heavy opposition, 18 state legislatures passed 71 chemical safety laws since 2008 with “overwhelming, bipartisan margin,” wrote Sustainable Business. more passages are expected in 2011.
Despite tremendous public support for increased regulation concerning toxic chemicals, Congress has acted on the side of industry. but, policies under consideration this year in the state legislatures include comprehensive laws in nine states to change chemical regulation at the state level and BPA phase-outs in at least 17 states, to name just two.
BPA is a plastic hardening chemical whose ubiquity is legendary.
I ask this question because last week there was a widely reported story about a warning that the FDA issued regarding breast implants. indeed, on Wednesday, our press people were circulating copies of the advisory and asking if any of us were available to comment to the press before the evening news deadlines. Unfortunately (or fortunately, depending on your point of view), I was holed up for our NCI site visit rehearsal and thus in essence unavailable. so it was that the national media missed its opportunity to hear me opine my wisdom on the matter to a breathlessly waiting nation. Talk about dodging a proverbial bullet (our nation, that is). be that as it may, this FDA advisory led to stories in the media like this one by ABC News, FDA Reports Link between Breast Implants and a Rare Cancer:
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.
This is the sort of epidemiological question that drives physicians and scientists crazy. the reason is quite simple. ALCL is a rare type of non-Hodgkin’s lymphoma (NHL). indeed, it is classified as a “rare disease,” which for purposes of U.S. policy is defined as affecting less than 200,000 Americans. in actuality, ALCL affects far fewer Americans than that. according to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI), approximately 1 in 500,000 women is diagnosed with ALCL in the the U.S. every year. ALCL of the breast is even more rare, with 3 in 100 million women per year being diagnosed with the disease. not surprisingly, that means it’s incredibly hard to get enough patient numbers to make firm conclusions regarding whether the risk of ALCL is truly higher in women with breast implants, and the FDA report, Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses, reflects this uncertainty.
Reading the FDA’s report, I was struck by how little there evidence is one way or the other because of the relative rarity of the disease. Basically, the evidence portion of the FDA report concentrates on case studies and the three existing studies that tried to determine whether there is an association between breast implants and ALCL. Given that the report strikes me as being pretty accessible to the lay person, I recommend reading it, because it reveals a careful sifting of the thin gruel of evidence and how the FDA came to its decision to issue this warning. I’ll try to summarize its 21 pages for you and give you my take on the studies used to justify the warning, but go to the full report for details.
The FDA performed a review of the scientific literature. This included a search of PubMed, Embase, Web of Science, Cambridge Scientific Abstracts (CSA), EBSCO, and BIOSIS for published papers and abstracts about ALCL and breast implants. after duplicates were accounted for, the FDA found that the entire world scientific literature has reports of 34 women with breast implants who were diagnosed with ALCL of the breast. As pointed out above, the number might be as high as 60, as is described in the report:
in a thorough review of scientific literature published from January 1997 through May 2010, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. the FDA’s adverse event reporting systems also contain 17 reports of ALCL in women with breast implants. Additional cases have been identified through the FDA’s contact with other regulatory authorities, scientific experts, and breast implant manufacturers. in total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. the exact number is difficult to verify because reports from regulatory agencies and scientific experts often duplicate those found in the scientific literature.
It’s estimated that there are between 5 and 10 million women in the world with breast implants. Given these numbers, the number of women with breast implants who have developed ALCL of the breast is higher than would be expected from SEER data alone. moreover, another thread of association that is concerning derives from the spatial pattern noticed in these case reports:
of the 34 cases, the median time from breast implant placement to ALCL diagnosis was 8 years, with a range from 1 year to 23 years. Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as persistent seromas, capsular contractures, or peri-implant masses warranting breast implant revision operations. in each case, lymphoma cells were found in the effusion fluid (seroma) surrounding the implant, in the fibrous capsule, or within a peri-implant mass. Typically, there was no invasion beyond the fibrous capsule into the breast parenchyma.
It should also be noted that it couldn’t be determined whether there was a higher risk of ALCL that could be attributed to silicone versus saline implants, as twenty-four had silicone implants, seven had saline, and the type of implants was unknown. Similarly, there didn’t appear to be a correlation between the indication for implant placement and the risk of ALCL. of the 34 cases, eleven patients had their implants placed for breast reconstruction, nineteen patients received implants for breast augmentation, and in four cases no reason for placement of the implants was reported.
Unfortunately, these case reports are not particularly illuminating.
Given that, perhaps the epidemiology will be more revealing. Except that it isn’t. There are only three studies cited looking at whether there is an association between the presence of breast implants and ALCL of the breast. There were no prospective cohort studies. indeed, all three studies were in essence retrospective studies. of these, only one of them was designed to look specifically at a correlation between breast implants and ALCL of the breast, rather than observations of non-Hodgkin’s lymphoma and other cancers in women with breast implants. This study (de Jong et al, 2008) is an individually matched case-control study that mined a nationwide population cancer database from the Netherlands. Since 1971, all reports on cytological and pathological diagnoses generated by every pathology department in the Netherlands have been stored in a central database (PALGA, Pathologisch Anatomisch Landelijk Geautomatiseerd Archief).
Going to show that lymphoma of the breast is a rare entity, between 1990 and 2006, only 429 cases of histologically proven lymphoma of the breast were found, and, of the 389 women eleven had a diagnosis of ALCL. using these cases as the basis, de Jong et al performed an individually matched case-control study thusly:
Subsequently, we performed an individually matched case-control study, nested in the same cohort of 389 female patients. for each case patient with ALCL in the breast, we attempted to select 3 to 7 controls with other lymphomas in the breast, matched on age at diagnosis (±5 years) and year of diagnosis (±2 years). for all 47 potential controls, we obtained pathology reports. Furthermore, for all cases and controls, we sent a standardized questionnaire to the treating physician to obtain information on medical history, including previous malignancies, staging results, and presence of a breast prosthesis, including mammography results.
Conditional logistic regression analysis was performed to estimate the odds ratio (OR) of ALCL associated with breast prosthesis, using EGRET for Windows, 1999 (CYTEL inc, Cambridge, Massachusetts).21 the OR was used as a valid risk estimate of relative risk and is therefore referred to as such. An estimate for absolute risk was made based on breast prosthesis sales figures for 1999 to extrapolate the number of women with breast prostheses.
Based on this analysis, de Jong et al estimated the odds ratio of ALCL associated with breast implants to be 18.2 (95% CI 2.1-156.8). what this means is that the odds of having a breast implant were 18.2 times higher in ALCL patients than in the control lymphoma patients. Personally, I have a few problems with this analysis. First, the matching was done on only two criteria, age and year of diagnosis. Although there was no statistically significant difference in age between the groups, there’s no way of knowing if there were any confounding factors that were associated with ALCL of the breast. the numbers are just too small. consequently, it’s hard to say much about this series except that it is suggestive that there is an elevated risk of ALCL due to breast implants. As the authors themselves say:
although an 18-fold increased odds for the development of a specific lymphoma in the breast may cause significant concern among women with breast prostheses, it should be realized that the absolute risk remains very low due to the exceedingly rare occurrence of ALCL in the population (estimated incidence at all sites 0.1/100,000 per year).
Which is about one in a million. even if the estimate made by de Jong et al is accurate, that would put the risk at around 18 in a million.
As for the other two studies, they’re not exactly studies. One (Brinton et al) is a systematic review of the literature looking for evidence of an association between breast implants and cancers at other sites. Brinton et al concluded that breast lymphomas in women with breast implants tend to be associated with the periprosthetic capsule, or in proximity to the implant. moreover, in the general population, breast lymphomas tend to be a rare entity and most are of B-cell origin. in contrast, breast lymphomas in women with implants tend to be of T-cell origin. the second, Lipworth et al, examined five long term studies of women with breast implants including 43,000 women to assess the risk of lymphoma in these women. This review actually found that there was a slightly decreased risk of lymphoma in women with breast implants, but, as the FDA report noted, it had a at least two weaknesses. First, all the studies began following women more than 35 years before the study, and the entity of ALCL was not defined pathologically until 1985. Second, the number of women studied was inadequate to rule out a rare relationship between breast implants and ALCL.
As you can see, the evidence for a link between ALCL and breast implants is fairly sparse. of the evidence, de Jong et al is probably the most suggestive, but even it is relatively weak, at least based on numbers alone. However, another piece of evidence comes from the characteristics of implant-associated lymphomas. More suggestive is the observation that such lymphomas were either found by the aspiration of lymphoma cells in the fluid surrounding the implant (it’s not uncommon for implants to have a fluid collection surrounding them) or in the connective tissue capsule that develops around many breast implants. Add this to the seeming statistical association between breast implants and ALCL, and there might just be something there. It’s not possible to conclude with any degree of certainty that there is such a risk right now; there are simply too few cases and ALCL is too rare, both in the general population and in women with breast implants.
Despite the controversy over the years over breast implants, particularly silicone breast implants, there has been no convincing evidence of a link between systemic diseases, such as autoimmune diseases or cancer. indeed, since the 1990s, there have been at least a dozen comprehensive systematic reviews looking at a potential link between silicone breast implants and systemic diseases (conveniently listed at Wikipedia), none of which have found convincing evidence for a link. in 2006, Brinton et al found an increased risk of death from lung cancer and suicide in women with implants, but these risks were attributed to increased smoking and psychiatric disorders in women who have implants placed.
This report from the FDA suggests that there might be an increased risk of a rare cancer in women with breast implants, but the numbers are so low that it’s difficult to conclude anything with much certainty, which is why the FDA concludes:
There is a possible association between breast implants and ALCL.
At this time, it is not possible to identify a specific type of implant associated with a lower or higher risk of ALCL.
There is uncertainty about the true cause of ALCL in women with breast implants.
Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. because ALCL is so rare, even in breast implant patients, 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.
These are reasonable conclusions based on the current state of the evidence, which is inconclusive at best, weak at worst. Given the high degree of uncertainty, what the FDA has done is not entirely unreasonable, although one could argue that it’s a tad alarmist. Basically, the FDA wants clinicians to consider ALCL in women with implants who have persistent seromas (fluid collections) around their implants, recommending that seroma fluid be sent for cytological analysis to rule out lymphoma. in addition, the FDA recommends that any confirmed cases of ALCL associated with implants be reported and is establishing a registry in collaboration with the American Society of Plastic Surgeons to track cases of implant-associated lymphoma. even this might not be able to detect or confirm a link between implants and ALCL, given the rarity of the disease, but it is a start.
Even accepting the most pessimistic assumption, namely that there really is a significantly elevated risk of ALCL in women with breast implants due to the implants, which has been suggested but not by any means established, this risk, if it exists, should be put into perspective. for example, it should also be noted that, based on what we know, in women who choose implants for reconstruction after breast cancer surgery, the risk of recurrence of their breast cancer is orders of magnitude greater than any theoretical risk of ALCL due to implants. indeed, in women who have never had cancer and choose implants for breast augmentation, the risk of developing breast cancer is also orders of magnitude higher than of developing ALCL. There is no evidence that implants increase the risk of breast cancer or breast cancer recurrence after breast cancer surgery.
In fact, the most significant risk due to breast implants is not the risk of systemic diseases, such as autoimmune diseases or cancer. far more significant is the rate of local complications, such as capsular contracture or implant rupture. Due to such complications, many women with implants require reoperation. indeed, reoperation rates have been estimated to be as low as 3% after seven years to as high as 20% over three years. These are by far the most significant risks due to breast implants.
I have observed in the past that the controversy over the safety of silicone breast implants is a lot like the manufactroversy regarding vaccines in that no amount of evidence will sway those who have become convinced that implants are responsible for a wide variety of autoimmune and other systemic diseases. On the other hand, I must concede that the local complications due to rupture or scarring can in some cases be quite disfiguring and debilitating. this newly reported association between implants and ALCL doesn’t really change that assessment, given how tiny the risk is, even at its worst assessment. Surprisingly, I haven’t seen anything on NaturalNews.com or Mercola.com about the FDA report yet. maybe the report won’t be used as the basis for another campaign of fear mongering.
Naaaaah. It’s just a matter of time.
<a href="http://scienceblogs.com/insolence/2011/01/breast_implants_and_a_rare_cancer_did_th.php?utm_source=networkbanner&utm_medium=linktag:news.google.com,2005:cluster=http://scienceblogs.com/insolence/2011/01/breast_implants_and_a_rare_cancer_did_th.php?utm_source=networkbanner”>Breast implants and a rare cancer: Did the FDA go far enough? : Respectful Insolence
The U.S. Food and Drug Administration (FDA) is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.
Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. the drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. the FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.
“Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “It is important that people know to keep both children and pets away from the product to minimize exposure,” Dr. Beitz added.
Evamist was FDA approved in 2007. from July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages three to five years of age. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males.
Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.
Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child’s skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product.
If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.
At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. the FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.
Consumers and health care professionals should report any side effects from Evamist by using the FDA’s MedWatch Adverse Event Reporting program at fda.gov/MedWatch or by calling 800-332-1088.
New Delhi, Jul 19 : The Health Ministry today issued an advisory asking general public to refrain from using ‘dietary supplements’ which contained steroids due to the risk involved in usage of such products including acute liver injury and infertility.
”It has been brought to the knowledge of Food Safety and Standards Authority of India by Food and Drug Administration of Unites States of America that there is a possibility of entry of some products containing Steroid/Steroid-like substances in India as ‘Dietary Supplement’,” the ministry said. these products were subjected to class-I recall in United States as some of these were marketed without an approved new Drug Application or a Generic Drug Application but most were marketed as ‘Dietary Supplement’. however, the products were found to be containing steroid or steroid-like substances making them unapproved new drug. Most of these products were distributed through internet rather than through a distributor network, it pointed out. ”Steroid containing products present a risk of acute liver injury to product users. In addition, steroids may cause other serious long-term adverse health consequences in people including children. these may include male infertility, masculinisation of women, breast enlargement in males, short stature in children, adverse effects on blood lipid profile and increased risk of heart attack and stroke and death,” it pointed out and asked people to refrain from using them. A complete list of these products may be seen at the website of the Authority fssai.gov.in under the item ‘Advisories’. it can also be seen at fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm188929.htm, the ministry said.
Copyright © 2012 HealthDay. all rights reserved.
