Atkins, Augmentation and the FDA

1. Atkins, Augmentation and the FDA Finding Factual Information About Today’s Top Health Trends Sally Patrick Valeri Craigle Nancy Lombardo Spencer S. Eccles Health Sciences Library

2. What is health? • Quality of life? • A positive self-image? • Conducting out daily lives in comfort? • Energy to do the things we want to do? • The absence of pain and disease?

3. In pursuit of the APPEARANCE of health • Body shape and proportion • Femininity/masculinity • Virility • Strength • Energy • Youth

4. The reality of health in the United states • Obesity • 60 million obese, 9 million severely obese. (AOA, 2005) • Cancer • Men: 1 in 2 lifetime probability of developing cancer • Women 1 in 3 lifetime probability of developing cancer • Mental Health • Eating disorders (~7 million girls/women) • Environmental Toxicity • Substance abuse

5. "Feeling good about the way they look is high on the list of priorities for many Americans." ASAPS President Robert Bernard, MD, of White Plains, NY

6. Health Trends • Today’s most popular health trends: • Fad Diets • 91% of women on a college campus, diet "often" or "always." (Kurth et al., 1995) • Elective plastic surgery • Up 20% from 2002-2003 (American Society for Aesthetic Plastic Surgery) • Pharmaceuticals • People are increasingly relying on pills to fix their health problems

7. Would these health trends be so pervasive in society if the public had more factual information?

8. Health Information for the Public • The role of the information professional: • What we can do: • Facilitate the discovery of quality, reliable information • Help people think critically about health information and their sources • Guide people to be more proactive in their own health care • What we can’t do • Make decisions for health consumers about their own health choices

9. Common Sources of health information • The Internet • Family and Friends • Physician/Health care provider • The medical literature • Language is difficult • Health consumers now have a wealth of medical information written for them

10. How do you check the reliability of information? Who runs this site? Who pays for the site? What is the purpose of the site? Where does the information come from? What is the basis of the information? How is the information selected? How current is the information? How does the site choose links to other sites? What information about you does the site collect, and why? How does the site manage interactions with visitors? 10 Things to Know about Evaluating Medical Resources on the Web (National Center for Complementary and Alternative Medicine)

11. Finding Factual information • Dietary fads Sally Patrick • Plastic Surgery/Elective Breast Augmentation Valeri Craigle • Pharmaceuticals and the FDA Nancy Lombardo

12. Atkins, Augmentation & the FDA:FAD DIETS Sally M. Patrick, M.L.S. Project Director Utahealthnet Spencer S. Eccles Health Sciences Library University of Utah Utah Library Association May 12, 2005

13. We’re All Confused!

14. My Health/My Responsibility We are swimming in “beauty” media with little evidence-based promotion of health • http://www.MyPyramid.gov • US Dept of Agriculture’s most recent attempt to personalize nutrition

15. What is a Fad Diet? • Promises dramatic results • No long term success • Not balanced/unhealthy • Based on your insecurities • Much Marketing/Little Science • Go in and out of fashion

16. Some Common Fad Diets • Diet Type • Controlled Carbohydrates • Dr. Atkins’ New Diet Revolution • The Carbohydrate Addict’s Diet • Protein Power • Sugar Busters • The Zone

17. Some Common Fad Diets • Diet Type • High Carbohydrate/Low Fat • Dr. Dean Ornish: Eat More, Weigh Less • The Good Carbohydrate Revolution • The Pritikin Principle • Controlled Portion Sizes • Dr. Shapiro’s Picture Perfect Weight Loss • Volumetrics Weight Control Plan

18. Some Common Fad Diets • Diet Type • Food Combining • Fit for Life • Suzanne Somers’ Somerizing • Liquid Diets • Cambridge Diet • Slim-Fast

19. Some Common Fad Diets • Diet Type • Diet Pills/Herbal Remedies • Dexatrim Natural • Hydroxycut • Metabolife 356 • Other • Eat Right For Your Type: The Blood Type Diet • Macrobiotics • May Clinic Diet (not endorsed by the clinic)

20. If fad diets don’t work, why are they so popular? • People willing to try anything to look/feel better regardless of true health • Promoters take advantage of get slim quick ethic with little effort required • Some do lose weight but cannot maintain-mostly water & lean muscle, not body fat-regain

21. Weight Management & Good Nutrition • Eat breakfast & don’t skip meals • Eat a variety of foods for daily nutrients • Limit daily intake of: saturated fat, cholesterol, sodium and sugar • Limit liquid calories-whole fruits rather than sugar enhanced juices • Watch portion size • Exercise on a regular basis-calories in>calories out • Aim for a more physically active lifestyle including 30-60 min./4-6 times per week

22. Resources for Good Nutrition… • Mayo Clinic/Healthy Living/Food & Nutrition http://www.mayoclinic.com/findinformation/conditioncenters/ centers.cfm?objectid=000851DA-6222-1B37 8D7E80C8D77A0000 Basics of healthy diets, food & health connection & tips for shopping & cooking

23. Resources for Good Nutrition… • U.S. FDA-Center for Food Safety & Applied Nutrition http://www.cfsan.fda.gov/~dms/foodlab.html “How to Understand & Use the Nutrition Facts Label”

24. Resources for Good Nutrition… • MedlinePlus - http://medlineplus.gov/ Reliable nutrition/diet information for consumers Special resources for senior health

25. Resources for Good Nutrition… USDA National Agricultural Library/Food & Nutrition Information Center http://www.nal.usda.gov/fnic/index.html Educational materials, government reports, research papers and a consumer’s corner Special resources for those who work with kids

26. Resources for Good Nutrition… • American Heart Association/Diet & Nutrition http://www.americanheart.org/presenter.jhtml?identifier=1200010 Healthy lifestyles, dietary recommendations and “Delicious Decisions”

27. Resources for Good Nutrition… • USDA National Agricultural Library http://www.nutrition.gov Gateway to nutritional information and research from the federal government Includes information on dietary supplements, food allergy & safety, sports & exercise

28. Resources for Good Nutrition… • American Academy of Family Physicians/Healthy Living/Food & Nutrition http://familydoctor.org/x5242.xml Easy to use and complete site for general nutrition, kids & nutrition, improving your nutrition

29. Resources for Good Nutrition… • Public Citizen/Health Research Group/Food Information Center http://www.citizen.org/hrg/food/index.cfm National non-profit public interest organization Food information/Safety-dyes, irradiation, labeling, infant formula, etc

30. Atkins, Augmentation & the FDA:Breast Augmentation Valeri Craigle, Project Coordinator Neuro-Ophthalmology Virtual Education Library (NOVEL) Spencer S. Eccles Health Sciences Library University of Utah Utah Library Association May 12, 2005

31. The Headlines • Breast implants don’t cause serious illnesses, panel says (4/13/1999) • Dow Corning Corp. has offered 3.2 billion to settle silicone breast implant lawsuits • FDA approves saline breast implants (05/11/2000) • FDA study shows silicone breast implants rupture (05/18/2000) • FDA rejects silicone breast implant request (1/8/2004) • FDA to reconsider silicone implant ban (4/8/2005) • FDA panel recommends lifting implant ban (4/13/2005)

32. Breast augmentation in the US • Augmentation facts • Caucasian Women aged 19-34 have the highest rate of breast augmentation surgery • 150,208 augmentations last year • 54% of all augmentations in this age group • 51% have complications/follow up surgery (440,000 women brought suit against Dow Corning in 1999) • 20-30% eventually have implants permanently removed • Third most performed cosmetic surgery in the US • Each year, numbers are up 8-10%

33. Primary sources of information for this age group • Peers • Friends • Co-workers • Family members • The Internet • The media • Television • Magazines • Health Care Provider

34. The Power of the Media

35. On Television • Dr. 90210 • Extreme makeover • I want a famous face • The Swan • Fear factor

36. In the magazines

37. A hypothetical Scenario A young woman has several friends who are getting breast implants. She is starting to think she wants them too, but she has a lot of questions. She goes looking for information

38. She goes to the Web first • The first result in Google: Implantinfo.com

39. The possible appeal of this site • Site designed by a “peer” (Nicole) • Attractive/well-organized design • Satisfaction survey! (94% satisifed) http://www.implantinfo.com/inforesources/implantsurvey.pdf • Stories from women who have gone through it • Sponsors are Doctors

40. What are the dangers of this site? • Sponsors are Doctors (Plastic surgeons) • Information is dated • Information is not objective • The “Information Resources” and “Research” section contain selective information based on Nicole’s biases

41. Ok, what does the Gov’t say? • The FDA’s Breast implant Web site, Comsumer Handbook: • http://www.fda.gov/cdrh/breastimplants/ • Making an Informed Decision (Inamed!): Saline-Filled Breast Implant Surgery http://www.fda.gov/cdrh/breastimplants/labeling/inamed_patient_labeling_5900.html

42. FDA’s list of possible complications • • Delayed wound healing • • Redness/bruising • • Extrusion • Rupture/deflation • Galactorrhea • Scarring • Granuloma • Seroma • Hematoma • Unsatisfactory style/size • Iatrogenic injury/damage • Wrinkling/rippling • Infection, including Toxic Shock Syndrome • Asymmetry • Inflammation/irritation • Breast pain • Malposition/displacement • Breast tissue atrophy • Necrosis • Calcification/calcium deposits • Nipple/breast sensation changes • Capsular contracture • Palpability/visibility • Chest wall deformity • Ptosis

43. Other FDA findings • Reoperation is 20-26% at 5 years for augmentation patients (Mayo Clinic study) • Silicone rupture rate across studies is – 3-77% ???!!! • Connective tissue diseases and neurological disorders are reported by women who have implants, but no relationship can be proven

44. Evaluating the FDA’s Findings • The GOOD • Multidisciplinary scientific oversight • Anesthesiologists, pathologists, epidemiologists, oncologists etc… • FDA studies claim to be all inclusive • All patient records are included, nothing (that we know of) is left out of their studies • The BAD • The FDA’s recommendations are confusing/ambiguous • Lack of consistency in recommendations • Information on the Web site is dated • The Ugly • Inamed and Mentor (Manufature wars) make it difficult to determine what the FDA’s position is

45. Trusted resources (MedlinePlus.org)Non-profit • The Implant Information Project of the National Research Center for Women & Families http://www.breastimplantinfo.org/ • National Cancer Institute Breast Implant study (only covers breast cancer and connective tissue disorder info: http://www.cancer.gov/newscenter/siliconefactsheet • For teens: Can I make my breasts larger? http://www.kidshealth.org/teen/expert/body/larger_breasts.html

46. …With a grain of saltSites sponsored by plastic surgeons, or implant manufacturers • http://mentor4me.com • http://www.ebreastaug.com • http://www.breastimplants411.com/ • http://www.inamed.com • http://inplantinfo.com

47. In General • Our young woman needs to know who is funding the studies and sponsoring the Web sites: • Plastic surgeons • Implant manufacturers • Special interest groups • The government • Look beyond the headlines: • NCI Study Finds No Long-Term Health Effects from Breast Implants • NCI Study Finds No Conclusive Evidence that Breast Implants Affect Development of Connective Tissue Disorders

48. Another consideration: Cost • There is no definitive source of info on cost, but in general: • Surgeon’s fee From $1,600 – 6,000 • Price depends on the state she lives in • This price does not include anesthesia, hospital costs, or the implants themselves • Implant removal 20,000 (out of pocket)

49. Based on the information our young woman has received from all of these sources, what can she say she is certain about?

50. A LOT of women are getting breast • Many women are satisfied with their implants • Implants do NOT last a lifetime • The SAFETY of implants has not been proven or disproven • There are HEALTH RISKS associated with Breast augmentation • Insurance companies WILL NOT COVER elective augmention or elective removal of implants • Additional medical care will be required in the future