Laura Julstrom, BA

Are you or someone you love trying to start a family or have another baby?  Taking a few preventative measures today might make it easier to get pregnant and have a healthy baby. 

A new study suggests that men or women exposed to heavy metals in their environment makes it more difficult for a woman to get pregnant.  The researchers were headed by Germaine M. Buck Louis, who works at the National Institute of Child Health and Human Development, which is part of NIH.   The study is called the LIFE Study, which is short for the Longitudinal Investigation of Fertility and the Environment.

Toxic Metals

There are many “heavy metals” that are used in products in everyone’s home, such as non-stick pans, glazed ceramics, pesticides, soaps, plastic toys^[1]., eye shadow ^[2], and lipstick^[3]. Examples of heavy metals include lead, cadmium, and mercury. Although these are “natural” elements, they can be harmful to your health, especially over a long period of time or in high doses.^[4]

Most people have small traces of heavy metals in their blood, but some of us are exposed more often and to greater amounts than other people, because of where we live and what we do. We should be aware of the ways we come into contact with these metals, and find ways to limit our exposure.

There are ways to reduce your exposure to heavy metals, even if you work in or live close to a factory that makes products containing cadmium (batteries, metal coatings, and plastics).  If you live in a home built before 1978, you might be exposed to lead in the paint in your house.^[5] Renovation or construction in these homes releases contaminated particles that can be inhaled or absorbed through the skin.  Fish, plants, and animals absorb cadmium from the environment and so all foods contain at least low levels of the metal.  People can also be exposed to toxic metals in cigarette smoke. ^[6]  Smoking or being around others who smoke increases cadmium levels in your body.^[7]This is yet another reason to avoid cigarettes.

Cadmium, Lead and Pregnancy Delay

A couple’s fertility depends on the fertility of both the man and the woman. Both male and female fertility influence how long it takes for a couple to get pregnant.  The LIFE Study’s data show that if either a man or woman is exposed to cadmium, that can delay a woman’s chances of getting pregnant.^[8]

Other metals are also influential.  The more lead there is in a man’s blood, the longer it will take his wife to get pregnant because lead lowers a man’s sperm count and also reduces the mobility of the sperm. ^[9]  Lead or cadmium can affect a women’s reproductive hormone levels and this might make it more difficult to conceive. ^[10]

Protect Yourself

If we educate ourselves and others and take preventative steps to protect our health and safety, we can reduce our exposure to heavy metals that damage our health.  Here are some suggested strategies:

• Quit smoking and avoid being around tobacco smoke.
• Only use cold tap water for drinking and cooking,^[11] even if you plan to boil it.
• If you work in a place where heavy metals are used, make sure your employer provides personal protective equipment when necessary and always remove your work clothes and shower before returning home.
• Have your pre-1978 home tested for lead paint indoors and outdoors.
• If possible, have trained professionals remove or cover lead paint in your home, and make sure they do it the right way.^[12] Visit the U.S. Consumer Safety Commission website for guidelines (http://www.cpsc.gov/cpscpub/pubs/5054.html).
• If you are concerned about lead in your home or community contact the National Lead Information Center by phone at 1-800-424-LEAD or at http://www.epa.gov/lead/pubs/nlic.htm for more information.

1 Occupational Safety & Health Administration. Chemical Identification, Production and Use of Cadmium. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=818&p_table=PREAMBLES Accessed February 23 2012.

2 Sainio EL, Riitta J, Hakala E, Kanerva L. Metals and arsenic in eye shadows. Contact Dermatitis. 2000; 42(1): 5-10.

3 U.S. Food and Drug Administration. Lipstick and Lead: Questions and Answers. http://www.fda.gov/cosmetics/productandingredientsafety/productinformation/ucm137224.htm   Accessed February 23 2012.

4 Occupational Safety & Health Administration. Toxic Metals.  http://www.osha.gov/SLTC/metalsheavy/index.html  Accessed February 23 2012.

5 U.S. Consumer Product Safety Commission. CPSC Announces Final Ban on Lead-Containing Paint: Release # 77-096. http://www.cpsc.gov/cpscpub/prerel/prhtml77/77096.html.  Published September 1977.  Accessed February 23 2012.

6 National Institute of Child Health and Human Development. NIH study links high levels of cadmium, lead in blood to pregnancy delay. http://www.nih.gov/news/health/feb2012/nichd-08.htm.  Published February 2012.  Accessed February 23 2012.

7 Office of the Surgeon General. Consequences of Involuntary Exposure to Tobacco Smoke: Report of the Surgeon General, U.S. Department of Health and Human Services. http://www.surgeongeneral.gov/library/secondhandsmoke/factsheets/factsheet9.html.   Revised January 2007. Accessed February 24 2012. 

8 Buck Louis GM, Sundaram R, Schisterman EF, Sweeny AM, Lynch CD, Gore-Langton RE, Chen Z, Kim S, Caldwell KL, & Barr DB. Heavy metals and couple fecundity, the LIFE Study. Chemosphere. 2012; In press.

9 Apostoli, P, Kiss, P, Porru S, Bonde, JP, Valhoorne, M, and ASCLEPIOS Study Group. Male reproductive toxicity of lead in animals and humans. Occupational and Environmental Medicine. 1998; (55): 364-374.

10 Pollack AZ, Schisterman EF, Goldman LR, Mumford SL, Albert PS, Jones RL, Wactawski-Wende J. Cadmium, Lead, and Mercury in Relation to Reproductive Hormones and Anovulation in Premenopausal Women. Environmental Health Perspectives. 2011; 119 (8): 1156-1161.

11 Centers of Disease Control and Prevention. Lead: Prevention Tips. http://www.cdc.gov/nceh/lead/tips.htm. Accessed February 23 2012.

12 U.S. Consumer Safety Commission. What you should know about lead based paint in your home: Safety Alert. CPSC Document #5054. http://www.cpsc.gov/cpscpub/pubs/5054.html.  Accessed February 23 2012.

February 10, 2012

I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families. Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies.

Our Center has expertise in evaluating the safety and effectiveness of medical products, and specifically treatments for depression.  In addition to my graduate degree in public health from Columbia University, I have experience working with substance abusers in harm reduction and drug prevention programs.

I am here today to express our support for the FDA’s position that the available scientific evidence does not support reclassifying Cranial Electrotherapy Stimulators or CES. The Class III designation for CES for the indications of insomnia, depression or anxiety is warranted.

The studies that have been conducted on CES have conflicting results, with the more rigorous studies generally showing no advantage over placebo.

• Overall, the studies are marred by small sample sizes and inconsistencies that make them inappropriate to combine in meta analysis or to compare.
• Only 5 out of the 39 studies used DSM criteria to diagnose depression, anxiety or insomnia, which is a major failure of these studies.
• The studies fail to establish which patients with what kind of mental disorder or what kind of substance abuse are most likely to benefit in what way.
• The studies fail to establish the appropriate dose or even the appropriate placement of electrodes.
• What the available evidence does establish is that in studies where there was a control group, the placebo was often as effective as the treatment. The good news for those in the placebo arm is that they got some relief from their symptoms without the risk of seizure and without experiencing side effects like blurred vision, headaches or skin irritation. Although having substantial benefits from placebo is not unusual in studies of depression, that is not a justification for considering CES effective.

I am particularly disturbed by the lack of rigor in the studies on adult substance abuse patients. As the FDA correctly points out, “there are… differences in situational depression, anxiety, or insomnia related to chemical withdrawal versus these conditions as underlying clinical diagnoses.”

Given the limited success of evidence-based substance abuse treatment and the high rate of relapse, the last thing substance abuse patients need are devices that make promises they can’t deliver on, and which have risks that outweigh the rare and rarely statistically significant benefits. And, that would be a concern for patients with depression as well.  If a patient has already failed in attempting treatment with medication, it will contribute to feelings of hopelessness to also fail using CES, especially since most patients would consider electrical stimulation of the brain as a more radical treatment.

All of us share the desire to have more treatment options for patients.  But the FDA is not supposed to allow snake oil on the market.  We do patients no favors by allowing the sale of medical products whose effectiveness is questionable, especially when more effective treatments are available.  And, even more problematic, when the  product has risks such as seizures, blurred vision, and adverse effects from electrical stimulation of the brain.

In conclusion, it is not possible to conclude that CES provides a meaningful improvement compared to placebo for insomnia, depression, or anxiety.  Perhaps some patients would benefit in some way, but the scientific evidence does not adequately define a clinically accepted target population for whom the benefits of CES outweigh the risks in the treatment of insomnia, depression, or anxiety.  Since available valid scientific evidence does not demonstrate that CES is effective in treating those symptoms, any risks are unacceptable.  And CES clearly has substantial risks.

Under these circumstances, it would be unethical to clear CES for market based on a 510(k) application with controls such as subjective reports from the physicians who are paid for treatment and to patients who are clearly vulnerable to placebo effects.  What is needed is scientific evidence that CES is more effective than placebo, and that the benefits outweigh the risks.  A PMA is needed to establish whether or not that is true.  Without solid scientific evidence, it is impossible to conclude that there is a reasonable assurance of effectiveness or the absence of unreasonable risk of illness or injury.

Brandel France de Bravo, MPH and Diana Zuckerman, PhD

The Advisory Committee agreed with us and the majority recommended not to reclassify cranical electrotherapy stimulation for insomnia, depression, and anxiety as a “moderate risk” rather than “high risk” device.

Updated February 2012

An important step in keeping children safe from many childhood diseases is to make sure they are immunized on time. Below is the recommended childhood immunization schedule for January-December 2012. The schedule is approved by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American Academy of Family Physicians.

Vaccines are not 100% risk free, and a small proportion of children may have a bad response to a vaccine.  However, not being vaccinated carries more risks.  That is why all of the major health organizations mentioned above agree that the risk of not having a vaccine, to your child and to the public health for all children, is greater than the risk of the vaccine itself.

The one study that suggested a link between the Mumps, Measles, Rubella (MMR) vaccine and autism was declared a fraud and the study’s author has been barred from medical practice.

Concerns about the safety of mercury-based preservative, thimerosal, resulted in thimerosal being removed or reduced to trace amounts from all vaccines for children 6 and under (except for the flu vaccine–see below) since 2001.

Vaccine-Preventable Diseaes and the Vaccines that Prevent Them (To read more aboust each of the diseases listed below, visit this CDC website here)

Hepatitis B (Hep B vaccine): Three doses of the hepatitis B vaccine are recommended for childern to be protected against hepatitis B infection.

Dose #1: given at birth
Dose #2: given at 1 to 2 months (but at least one month after the first dose),
Dose #3: given at 6 to 18 months (but at least 4 months after the first dose and 2 months after the second dose).

If your child has not previously received 3 doses of the vaccine, he or she should start or complete the series at 11 to 12 years.

Rotavirus Vaccine (RV): Three doses are recommended.

Dose #1: given at 2 months
Dose #2: given at 4 months
Dose #3: given at 6 months

Vaccination should not be started for infants past the age of 15 weeks.
The maximum age for the final dose in the series is 8 months 0 days

Diphtheria, Tetanus, Acellular Pertussis (DTaP): Five doses of DTaP are recommended.

Dose #1: given at 2 months
Dose #2: given at 4 months
Dose #3: given at 6 months
Dose #4: given between 15-18 months
Dose #5: given between 4-6 years

Later routine diphtheria toxiods (Td) boosters are recommended every 10 years after the age of 11.

H. influenzae type b (Hib): It is recommended that children receive four doses of the Hib vaccine.

Dose #1: given at 2 months
Dose #2: given at 4 months
Dose #3: given at 6 months
Dose #4: given between 12-15 months

Polio (IPV): Children should receive four doses of IPV vaccine.

Dose #1: given at 2 months
Dose #2: given at 4 months
Dose #3: given between 6-18 months
Dose #4: given between 4-6 years

Influenza (seasonal): The inactivated flu vaccine should not be administered before 6 months, while the live flu vaccine is given to healthy children aged 2 years and older (i.e., those who do not have underlying medical conditions).

Pneumococcal Conjugate (PCV): PCV is recommended for all children younger than 5 years. The schedule recommends that PCV be given along with other childhood vaccines.

Dose #1: given at 2 months
Dose #2: given at 4 months
Dose #3: given at 6 months
Dose #4: given between 12-15 months

One does is recommended for children aged 24 to 59 months who are not completely vaccinated for their age.

One dose of PCV is recommended for children aged 24 to 59 months who are not completely vaccinated for their age.  The CDC also recommends a single supplementary dose of PCV13 for children of 14-59 months who have been completely vaccinated.

Measles, Mumps, Rubella (MMR): Two doses of MMR vaccine are recommended.

Dose #1: given between 12-15 months
Dose #2: given between 4- 6 years. (If 4 weeks have passed since the first dose, the second dose may be given during any doctors visit)

Children who have not previously received the second dose should complete the schedule at 11 to 12 years.

Children aged 6-11 months should receive the MMR vaccine if traveling internationally, according to the updated 2012 schedule.  The vaccine should be administered to this same group at age 12 months, and again between the ages of 4-6, with at least 4 weeks between doses.

Varicella (Var) (chicken pox): Two doses of the chickenpox vaccine are recommended.

Dose #1: given between 12-15 months.
Dose #2: given between ages 4-6.

If your child has not previously received the vaccine, he or she should receive the vaccine at 11 to 12 years.

Hepatitis A (Hep A): Two does of the Hep A vaccine are recommended.

Dose # 1 and dose #2: given between 12- 24 months, with at least 6 months between the two.

It can also be administered from 4 to 6 years, or from 11 to 12 years for high risk groups.

Please note that this vaccine is only recommended in selected states and/or regions. To check if it is recommended in your area, contact your local public health authorities.

Older Children

Tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap): Tdap is recommended as a booster immunization for adolescents.

Dose# 1: given between 11-12 years, if at least 5 years have elapsed since the last does of DTP, DTaP, or DT.

Later routine Td boosters are recommended every 10 years.

Human papillomavirus (HPV): Human papillomavirus is commonly spread through sexual activity. Certain strains of the virus can cause cancers, including cervical, vulvar, vaginal, penile, anal, and oropharyngeal (part of the throat); other types cause genital warts in both men and women.

Cervarix and Gardasil are the 2 approved HPV vaccines. Both protect against HPV 16 and 18, the strains known to lead to most cervical cancers; they also provide more limited protection against certain other HPV-associated cancers such as vulvar, vaginal, penile, anal, and oropharyngeal.  Cervarix is approved only for females; Gardasil is approved for use with both males and females. Gardasil also protects against HPV types 6 and 11, which can cause genital warts.

The 2012 vaccine schedule recommends a 3-dose series of Gardasil or Cervarix for girls between the ages 11 and 12, and a 3-dose series of Gardasil for boys between the ages of 11 and 12. There should be 4-8 weeks between the first 2 doses; the third dose should be administered 6 months after the 2^nd dose. The minimum age for the vaccine is 9 years, and the CDC recommends that it be given before the age of 26.

You can read more about the HPV vaccine here.

Experts at the National Research Center for Women and Families are concerned that while the HPV vaccine may be quite safe, data proving its long-term efficacy is still lacking. Gardasil and Cervarix are very expensive vaccines-the most expensive on the schedule-and yet we still do not know if and when a booster shot will be required. Cost-effectiveness and safety can not be fully evaluated without knowing how long the vaccine’s protection lasts. One worry is that children who get the vaccine when they are 11 or 12 may end up having  nadequate protection against HPV when they become sexually active teenagers. For this reason, some parents may decide to delay their children’s vaccination against HPV until they are a little older and more information on the vaccines’ duration and safety are available. Whatever parents decide-to vaccinate or not to vaccinate-starting at age 21, young women must get regular Pap smears,  a test used to screen for cervical cancer (to find out more, read Cervical Cancer Screening: The Key to Prevention on our Cancer Prevention and Treatment Fund Web Site).

Meningococcal Conjugate Vaccine (MCV): The meningitis vaccine can be administered after the age of 2. Recommended for previously unvaccinated college entrants who will live in dormitories. One dose will suffice for healthy college students whose only risk factor is dormitory living.

What should you do if your child is having a serious reaction to a vaccine?

If you think your child is having a persistent or severe reaction to a vaccine, you should call your doctor or take your child to a doctor immediately. It is important to write down what happened and the date and time it happened. You should also contact the Vaccine Adverse Event Reporting System (VAERS) or ask your doctor, nurse, or health department to do so.

What is VAERS?

The Vaccine Adverse Event Reporting System, which is sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), collects and analyzes information from reports of possible adverse events that occur following vaccination. VAERS encourages reporting of any clinically significant adverse event that occurs after the administration of any vaccine licensed in the U.S., even if it is not certain that the reaction was caused by the vaccine.

There are many different types of events that can occur after vaccination. About 85% of VAERS reports describe mild reactions such as fever, local reactions, episodes of crying or mild irritability, and other less serious events. Approximately 15% of the reports describe serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death.

In 1986, Congress asked the Institute of Medicine to conduct a scientific review of the possible adverse events following commonly used childhood vaccines. The Institute published two reports based on its findings; both concluded that adverse events caused by vaccines are rare.

For more information about VAERS, you can:

1.                   send email inquiries to info@vaers.org
2.                   visit the VAERS website at http://www.vaers.org
3.                   call the toll-free VAERS information line at 800-822-7967
4.                   fax inquiries to the toll-free information fax line at 877-721-0366

To find out if a certain vaccine adverse event has ever been reported to VAERS, send a written information request to:
Food and Drug Administration
Division of Freedom of Information (HFI-35)
Office of Shared Services
Office of Public Information and Library Services
5600 Fishers Lane
Rockville, MD 20857
Phone: 301-443-2414
You can also fax requests to: 301-443-1726

Cancer is not the only risk of polyurethane foam. The body can have a very bad immune reaction to the polyurethane, and since the woman’s scar tissue grows into the foam, the implants can be almost impossible to remove. When these implants are taken out for any reason, it is not unusual for some of the woman’s own breast tissue to be removed as well, leaving her with smaller breasts than she had before breast implants. Her breasts may also be deformed from the explant surgery.

FDA can be proud that they did not allow Silimed or PIP breast implants to be sold in the U.S. in recent years. Unfortunately, all of Europe was forced to allow Silimed implants on the market after German regulators awarded the CE mark, which indicated they met European quality standards. How did this happen? It’s simple; Europe requires almost no evidence of safety for medical devices, not even for implants. These lower standards have hurt tens of thousands of women with breast implants, and millions of men and women with other types of implants that were not tested in clinical trials.

To learn more about the Silimed implant scandal, please read this article in the Daily Mail.

Here’s what President Obama said:

“We’ve all paid the price for lenders who sold mortgages to people who couldn’t afford them, and buyers who knew they couldn’t afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices, don’t destroy the free market. They make the free market work better.”

To read the State of the Union address in full, please click here.

Here’s what Consumers Union, one of our coalition partners, said:

This isn’t science fiction. Millions of medical devices including artificial hips, surgical mesh, contact lens solution, heart stents, and pacemakers are being recalled – 700 different products a year.

And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were “similar” to products already on the market.

Tell Congress we don’t want to be guinea pigs anymore!

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren’t safety tested before being sold nor are they routinely tracked afterward to identify safety problems.

For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate, and leaving potentially deadly metal fragments in the body. Countless patients had to undergo a second, painful ‘revision’ surgery.

It’s time safety standards for medical devices are as strong as those for prescription drugs! Email your members now!

The device industry has unleashed an army of lobbyists and they don’t want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family.

Sincerely,
Lisa McGiffert
SafePatientProject.org
Consumers Union, policy and action from Consumer Reports
506 West 14th St., Suite A
Austin, Texas 78701

The U.S. Consumer Product Safety Commission tightened standards and safety regulations for cribs earlier in 2011, but you may still want to think twice before you tuck in your baby at night.  While the Commission required that cribs be sturdier, it is actually the mattress that may be putting children’s health in jeopardy.  A recent study conducted by Clean and Healthy New York, an organization promoting safer environments, reported that of the 190 crib mattresses investigated, 72% contained one or more chemicals that have been linked to health risks.^[1]

A mattress is usually composed of four parts: the core, a layer of padding, a layer of fire-resistant material, and a cover made from fabric.  Each of these four layers is made from materials that may contain potentially harmful chemicals.  Clean and Healthy New York investigated polyvinyl chloride (PVC), a petroleum-based plastic used in the cover of mattresses to make them waterproof and bacteria-resistant, and polyurethane foam, which is used in the core of mattresses and is also petroleum-based.  Although PVC is widely used in household products, it is one of the most toxic types of plastic.  In fact, the chemicals that make up PVC plastic have been known to leach into food and pose significant threats to the environment.  PVC is made from chlorine and other chemicals that can cause cancer, including phthalates that may also cause asthma or allergies.^[2] Polyurethane foam is dangerous because over time it breaks up into small dust-like particles that once inhaled can potentially cause asthma, skin irritations, or cancer.

Despite these risks, the part of the mattress that is of greatest concern is the fire-resistant layer.

As a result of new standards for mattresses set by the Consumer Product Safety Commission in 2007, mattress manufacturers have taken measures to make mattresses more fire-resistant.^[3] Unfortunately, there are few restrictions on the types of fire-resistant materials that can be used in mattresses.  This means that mattress companies can use chemicals with health risks.  Of the 28 mattress manufacturers that Clean and Healthy New York reviewed, 14 of them either used potentially harmful chemicals in their mattresses or refused to disclose their chemicals.^[1] The most dangerous chemical compounds used were polybrominated diphenyl ethers (PBDEs), a class of halogenated flame retardants (HFRs), which are designated by the Environmental Protection Agency as possible human carcinogens^[4] that may pose risks to the immune system or thyroid gland.^[4],^[5]

Figuring out which mattresses are safest for children and which to avoid can be difficult. Parents may have a hard time finding out what chemicals lurk in their baby’s mattress because manufacturers sometimes make labels hard to find or “green wash” their products when marketing them by deceptively emphasizing that environmental standards were used.  While laws require mattress companies to place labels directly on the product to describe the materials and chemicals used, the labels are often hidden from consumers, and mattresses are instead presented as safe and environmentally-friendly.  Additionally, mattress manufacturers attempt to conceal the health risks posed by chemicals in their mattresses by advertising or inventing certifications from trade organizations that support their products rather than evaluating the possible risks to consumers.  These certifications seem to focus on the manufacturers’ attention to safety and the environment while masking the potential health risks for consumers.  While PVC and polyurethane foam are widely-used chemicals, their presence in crib mattresses is worrisome given an infant’s small size, vulnerability, and the amount of time spent sleeping.  While the average adult hopes to have 8 hours of sleep a night, infants usually spend 12-14 hours sleeping each day.^[6] Furthermore, infants and young children have been shown to be at greater risk from environmental toxins because their bodies are still developing rapidly and their premature kidneys and liver may not detoxify substances in the same ways adults can.^[7]

Tips for Buying Safer Crib Mattresses

In light of these concerns, here are a few tips when purchasing a crib mattress:

• Third-party certifications that are developed by government agencies or non-profits are the most trustworthy.  Clean and Healthy New York has compiled a list of legitimate certifications to look for.
• These certifications are often only for parts of the mattress, not the whole product, so carefully examine certification documents as well as the labels.  If a mattress’s labels are hidden, visit the mattress company’s website or contact the company for information about the mattress’s contents when researching which product to buy.

Support Legislation that Keeps Families Safe from Dangerous Chemicals

The best way to ensure better standards for crib mattresses is to show support for policies that safeguard children’s health.  Manufacturers respond to consumers, and consumers are making it clear that they want toxic-free mattresses and full disclosure about the materials and chemicals found in them. If you are worried about the toxic chemicals that are currently unregulated in a range of household products, there is pending legislation in Washington, D.C. that addresses this important issue.  Senators Frank Lautenberg, Barbara Boxer, Amy Klobuchar, and Charles Schumer are championing The Safe Chemicals Act of 2011,^[8] which attempts to modernize the Toxic Substance Controls Act (TSCA) that currently governs the use of chemicals in consumer goods.

The Safe Chemicals Act of 2011 would:

• Require chemical companies to provide the Environmental Protection Agency (EPA) with more extensive data on the chemicals they produce
• Require the EPA to focus resources on the chemicals that are most likely to cause harm
• Expedite action to reduce the risk from chemicals of highest concern
• Reassess the safety of questionable chemicals currently approved for the market
• Promote efforts towards innovative chemistry that is green and safe
• Provide broad public access to reliable chemical information by establishing an EPA public database that will contain chemical information submitted to the EPA and decisions made by the EPA about certain chemicals

To take action and support the Safe Chemicals Act of 2011, visit the Safer Chemicals, Healthy Families website for more information.

The Bottom Line

Despite some risks, a crib that is free of pillows, thick blankets or other objects that could cause suffocation is still the safest place for an infant to sleep. When infants sleep with their parents they are at risk for the parents rolling over them and causing them harm. To view more crib safety tips, please visit the U.S. Consumer Product Safety Commission’s Crib Safety website for tips and videos on how to put your baby to sleep safely.

1 Clean and Healthy New York. The Mattress Matters: Protecting Babies from Toxic Chemicals While They Sleep. New York: Clean and Healthy New York and American Sustainable Business Council; 2011. Print.

2 Jaakkola JJK, Knight TL. The Role of Exposure to Phthalates from Polyvinyl Chloride Products in the Development of Asthma and Allergies: A Systematic Review and Meta-analysis. Environ Health Perspect. 2008;116(7):845-853.

3 Consumer Product Safety Commission. Standard for the Flammability (Open Flame) of Mattress Sets: Final Rule. March 2006. http://www.cpsc.gov/businfo/frnotices/fr06/mattsets.pdf. Accessed January 13, 2012.

4 US Department of Health and Human Services. Toxicological Profile for Polybrominated Biphenyls and Polybrominated Diphenyl Ethers. September 2004. http://www.atsdr.cdc.gov/ToxProfiles/tp68.pdf. Accessed January 13, 2012.

5 Zhou T, Taylor MM, DeVito MJ, Crofton KM. Developmental Exposure to Brominated Diphenyl Ethers Results in Thyroid Hormone Disruption. Toxicological Sciences. 2002;66(1):105-116.

6 Mindell JA, Owens JA. A Clinical Guide to Pediatric Sleep: Diagnosis and Management of Sleep Problems. Philadelphia: Wolters Kluwer and Lippincott Williams & Wilkins; 2010. Print.

7 Bearer CF. Environmental Health Hazards: How Children Are Different from Adults. The Future of Children: Critical Issues for Children and Youths. 1995;5(2):11-26.

8 The Safe Chemicals Act of 2011. http://lautenberg.senate.gov/assets/SafeChem-Summary.pdf. Accessed January 13, 2012.

By ANEMONA HARTOCOLLIS

Emily Moore at 202 223 4000 or EM@center4research.org

New Review Shows FDA is Missing Crucial Safety Information on Breast Implants

Washington, D.C.–As the scandal about dangerous breast implants spreads to many countries across the globe, the FDA can be proud that the agency did not approve implants made by that company, France’s Poly Implant Prothese (PIP).

A closer examination of the data regarding the FDA-approved breast implants made by Mentor and Allergan, however, indicates numerous errors and missing information in the FDA’s most recent research summary (published online in June 2011), as well as in the information the agency provided to their Advisory Panel that met to discuss breast implants in August 2011.

In an 11-page summary provided to the FDA by the National Research Center for Women & Families on January 5, 2012, the Center pointed out their concerns about “missing information and inaccurate or misleading data that were provided to the FDA Advisory Panel on breast implants and that are included (or missing) in the June 2011 summary on the FDA web and in other recent FDA materials.” The Center raised the following concerns and questions

• Missing information about signs and symptoms of connective tissue disease from 2005 and the most recent follow-up data, and an inaccurate summary of earlier findings
• Missing information about poor outcome on Quality of Life measures from 2005, and missing follow-up data
• Inaccurate cumulative complication rates for at least some outcomes
• Inaccurate and misleading presentation of rupture data, which should be presented per patient rather than per implant.
• Questions about which complications are presented per implant or per patient and questions about whether women with complications at 3 or 4 years were excluded from the 8- and 10-year follow-up samples.

As NRC President Dr, Diana Zuckerman pointed out: “Many of these issues were raised by our Center before the August meeting or during the public comment period during the meeting, but 5 months later they have still not been corrected or addressed.   For that reason, we have written a more detailed analysis with all the documentation FDA needs (based on FDA’s own documents) to review these matters.  As we have shown in our analysis, the companies’ own data indicate that it is unlikely that breast implants offer the quality of life benefits promoted by plastic surgeons and manufacturers, and at the same time their risks are more serious and probably more systemic than patients have been told.”

Key Members of Congress have also expressed concerns about the reported errors and the implications for women’s health.  Senator Olympia Snowe (R-Maine) remarked “When making such a significant medical decision, patients rightfully deserve and fully expect to have a complete picture of the risks and benefits of these implants.  Regrettably, the effort put forward on post-market studies thus far has been severely lacking, and these critical questions on complications and rupture rates must be answered without delay.”

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For more Information regarding Senator Snowe’s concerns, contact Chris_Averil@snowe.senate.gov

For information regarding the concerns of Rep. Rosa DeLauro (D-CT), contact Kaelan.Richards@mail.house.gov

AP NEWS. Matt Perrone, AP Health Writer.

WASHINGTON (AP) – Consumer safety advocates are questioning the Food and Drug Administration about incomplete and seemingly erroneous data used to support the safety of silicone breast implants in an agency review last year.

The FDA concluded last summer that silicone-gel implants are basically safe as long as women understand they come with complications. The agency reported that one in five women who get implants for breast enhancement will need to have them replaced within five years.

The National Research Center for Women and Families issued a letter asking why the FDA did not present information showing that women reported lower emotional, mental and physical well-being after implantation. Additionally, the group questions why figures submitted by implant manufacturers appear to show implant complications declining over time. Implants are known to fail over time.

WASHINGTON — Consumer safety advocates are questioning the Food and Drug Administration about seemingly incomplete and erroneous data used to affirm the safety of silicone breast implants last year.

The FDA concluded last summer that the silicone-gel implants are basically safe as long as women understand they come with complications. More than one in five women who get implants for breast enhancement will need to have them replaced within five years, the agency’s report concluded.

In August, an outside panel of physicians affirmed the FDA’s decision that the devices should remain available for both breast enhancement and reconstruction.

But the National Research Center for Women and Families says the FDA did not present information that showed women reported lower emotional, mental and physical well-being after implantation. Additionally, the group questions why figures presented by the FDA appear to show implant complications declining over time. The implants are known to fail over time.

“This shows problems with the data, since the complication rates are reported to be cumulative and should therefore stay the same or increase over time,” states Diana Zuckerman, the group’s president, in a letter to the head of FDA’s medical device division.

Most of the FDA’s data on the safety and effectiveness of breast implants comes from long-term studies conducted by the two U.S. manufacturers of the devices, Allergan Inc. of Irvine, Calif., and Mentor, a unit of Johnson & Johnson, based in New Brunswick, N.J.

When the FDA reviewed the initial applications for the devices in 2005, women using Allergan’s implants scored lower on nine out of 12 quality-of-life measures, including mental, social and general health. Women did report higher scores on measures of sexual attractiveness-body esteem.

Women implanted with J&J’s implants also scored worse on measures of physical and mental health. In the 11-page letter, Zuckerman questions why that information was not presented at FDA’s public meeting in August.

“Breast implants are widely advertised and promoted as a way to increase women’s self-esteem and positive feelings about themselves,” said Zuckerman, in an interview with the Associated Press. “But the implant companies’ own data, which the FDA made public in 2005 but ignored last year, shows the opposite.”

Silicone gel breast implants have traveled a long, winding regulatory path at the FDA over the last 20 years. The FDA banned the silicone-gel type in 1992 amid fears they might cause cancer, lupus and other diseases. For more than a decade, only saline-filled implants were available. But when research ruled out most of the disease concern with silicone, regulators returned the implants to the market in 2006 — with the requirement that manufacturers continue studying patients to see how they fare long-term.

When the FDA revisited the devices’ safety last year they relied on eight and 10-year follow-up data from J&J and Allergan, respectively. This followed up on similar data submitted in 2005.

Breast implants are known to rupture and break down over time. But Zuckerman points out in her letter that the company data seem to defy this trend, with complication rates falling over time.

For instance, Allergan’s reported rate of swelling among patients fell from 23 percent in 2005 to 9 percent reported in 2011. Rates of scarring similarly fell from 8 percent to 4 percent.

“This again raises questions about the accuracy of reporting, and whether patients with complications were excluded from the 10-year sample,” writes Zuckerman.

FDA staffers did not immediately respond to a request for comment Thursday.

The questions about FDA’s review of breast implants come amid a wave of recalls and warnings over similar devices across Europe and South America. The implants from French company Poly Implant Prothese are being pulled from the market amid fears they could rupture and leak silicone into the body.

French investigators say the now-defunct company used cheap industrial silicone, not medical-grade silicone, and that more than 1,000 women in France have had one or two implants burst. French health officials have agreed to pay for an estimated 30,000 women in France with the implants have them removed.

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