EGG DONATION IN GREECE: ALL YOU NEED TO KNOW


Assisted reproduction techniques help thousands of couples with infertility to circumvent their problem and become parents. Nevertheless, when it is not possible for a woman to conceive due to poor egg quality or from having no eggs at all, she may still become pregnant by using eggs from a donor.

The first pregnancy with egg donation was reported in 1983, and ever since, more and more women are choosing this procedure to achieve their dream of having children. The main reason for this trend is that women are increasingly postponing childbearing until later on in life, when their fertility is often reduced; another reason is that over the years, the process has become highly successful due to recent technologies advances and improved freezing techniques.

What is egg donation?

Egg donation is a form of assisted reproduction by which a woman donates her ova to enable another woman to conceive. These oocytes are fertilized by the recipient’s husband sperm, or alternatively by a donor sperm.

The resulting embryos are transferred into the recipient uterus, which has been adequately prepared to receive them. The difference with routine in vitro fertilization (IVF) is that the egg donor is not the recipient; that is, they are two different women.

If pregnancy occurs, the recipient will have a biological but not a genetic relationship to the child, and her partner (if he provided the sperm) will be both biologically and genetically related.

What are the indications for egg donation?

Egg donation may be considered in the following situations:

  • Premature ovarian insufficiency: a condition in which menopause begins earlier than usual, usually before the age of 40 years old. In most cases the cause is unknown, but it may be the result of certain diseases, chemotherapy, radiotherapy or surgical removal of the ovaries. Egg donation is also suitable for women who were born without ovaries.
  • Low ovarian reserve: when there is a decrease in the number of eggs, resulting in reduced chances of pregnancy. Generally, this is due to advanced reproductive age, as the number of oocytes -and therefore fertility- decreases rapidly after the age of 35-40 years old.
  • Genetically transmitted diseases: women affected by, or carriers of a significant genetic disease who would prefer not to pass this disease on to their child.
  • Previous history of failure with IVF: especially when egg quality seems to be the problem.

Who are the egg donors?

1) Anonymous, voluntary donors: According to the Greek law, candidate egg donors are covered by anonymity and are required to sign a specific consent for the donation of their genetic material. In order to accept a woman into an egg donation program she should meet the following requirements:

  • Age between 18 and 35 years old.
  • She should be healthy, non-smoker, with no personal or family history of genetic diseases.

By law, the donor receives financial compensation only for the loss of working days, travel and other expenses incurred during the treatment cycle in which she participates. In any case, egg donation is an altruistic, anonymous and voluntary act.

2) Egg sharing: Women undergoing IVF may agree to donate their surplus oocytes to other women with infertility.

3) Known donor: a person who is known to the recipient, usually a close relative of friend. According to the Greek law, oocyte donation is an anonymous procedure, that is, the donor has no access to the child born, nor the recipient to the donor. Therefore, in Greece the donation of ova to known persons is forbidden by law.

Evaluation of the egg donor


Each candidate donor, after being fully informed about the egg donation program, completes a thorough questionnaire on her family, medical and psychological history. In addition, she is the subject of a series of exams to determine whether her health is in good condition and she can respond properly to the hormonal therapy.

The evaluation involves a comprehensive physical and gynecological examination, as well as the assessment of her psychological and mental status, her genetic material and reproductive system.

In addition, donors undergo the following laboratory testing:

  • Blood type and Rhesus
  • Hepatitis B & C
  • HIV 1 & 2
  • Syphilis
  • Hemoglobin electrophoresis
  • Sickle cell trait testing
  • Cystic fibrosis (CF) mutation
  • Fragile X testing
  • Conventional karyotype. It is also possible to a perform a molecular karyotype, upon request of the recipient couple.

A donor is ineligible if either the questionnaire or the screening tests indicate the presence of risk factors, or clinical evidence of an infectious or genetic disease.

Evaluation of the recipient couple 


Adequate screening and preparation of the recipient couple are essential for the success of an egg donation program.

According to the Greek law, a woman is considered suitable to receive oocytes when her uterus has normal morphology and functionality and has not exceeded the age of 50 years.

The evaluation of the recipient couple is similar to that of couples undergoing routine IVF. First, the physician obtains a thorough medical history from both partners.

The assessment of the woman includes an in-depth physical and gynecological examination, a detailed pelvic ultrasound and laboratory testing. Briefly, the ovarian function, her blood group, and exposure to certain infections are examined. In addition, a Pap smear test and cultures for certain microbes (Neisseria gonorrhoeae, Chlamydia trachomatis, etc) are obtained.

In some cases, the uterine cavity is evaluated with hysterosalpingography (HSG), sonohysterography or hysteroscopy. If the woman is over 45 years old, a more thorough assessment of her cardiac function, pregnancy-induced hypertension and gestational diabetes risk are recommended. The effect of advanced maternal age on pregnancy will be discussed extensively, as well as any medical conditions that may affect pregnancy.

An embryo transfer trial before the actual procedure (“mock” embryo transfer) is strongly recommended. It allows to determine the best way to place the embryos into the uterus, and ensures that there are no unexpected obstacles along the way. Sometimes the cervix is very narrow and hinders the transfer of the embryos into the uterus; this may result in significantly reduced chances of pregnancy. In case of a narrow or distorted cervical canal, a cervical dilation may be recommended.

A treatment trial in a previous cycle with the same medications used for the endometrial preparations is proposed when possible, in order to assess the uterine response to hormone therapy.

The male assessment includes a semen analysis, blood group and genetic testing, among other exams.

According to the Greek law, the recipient couple should be tested for syphilis, hepatitis B and C, HIV-1 and HIV-2 within the six months preceding the treatment cycle.

The procedure

Preparation of the donor for egg retrieval 

The donor follows the procedure of a standard IVF. Initially, she undergoes ovarian stimulation, that is, she receives a combination of hormonal medications in order to achieve the development of a sufficient number of oocytes within the ovaries; egg development is monitored by ultrasound and blood exams at regular intervals. When the oocytes are at the appropriate size, ovulation is triggered by an injection of human chorionic gonadotropin (hCG). Oocyte retrieval, scheduled approximately 34-36 hours after hCG administration, entails the use of a needle which is inserted through the vagina into the ovaries, whereby the eggs are aspirated under ultrasound guidance. The procedure is carried out under a mild sedation.

The ova obtained are evaluated for their maturity and then fertilized with the partner’s sperm, which has been processed in the laboratory. Donor sperm may be also utilized when indicated.

The male partner should provide the semen sample the day of the donor’s egg retrieval. Alternatively, if the presence of the partner is not possible on that day, the semen can be cryopreserved (frozen) at an earlier time.

Preparation of the recipient for embryo transfer

In order for the embryos to implant into the recipient’s uterus, the endometrium (uterine lining) must be prepared and synchronized with the donor cycle.

There are numerous protocols for endometrial preparation. Briefly, women who still have menstrual period may receive an injectable medication for temporary suppression of the ovarian function. When the donor starts ovarian stimulation, the recipient receives a hormone called estradiol to achieve endometrial growth. Estradiol can be administered orally or through a transdermal patch. Ultrasound assessment of endometrial thickness -and occasionally blood tests- are performed during this period. On the day after the donor receives hCG, the recipient begins treatment with progesterone. Progesterone causes endometrial maturational changes that allow the embryo to implant. Progesterone can be administered by intramuscular injection, vaginally or orally. Besides estradiol and progesterone, other medications may be prescribed if required.

The embryos are transferred into the recipient’s uterus, usually within three to five days after fertilization of the eggs in the laboratory. Embryo transfer is done using a thin catheter inserted through the cervix into the uterus. If the recipient couple has extra embryos, they will be cryopreserved (frozen). Thus, it is possible to transfer these embryos at a later time without the need for another egg donation.

Hormonal therapy with estradiol and progesterone continues until the recipient takes a blood pregnancy test (β hCG). If the test is positive, the hormones are continued during the first trimester of pregnancy.

Success rates with egg donation

Since egg donors are young and healthy women, success rates are higher than those obtained with conventional IVF. The age of the recipient does not seem to affect the success of the procedure. According to data from the National Agency of Medically Assisted Reproduction, the pregnancy rate with egg donation in Greece is 54%.

Nevertheless, the greater the number of attempts with donor-egg IVF, the higher the odds of success. Thus, it is estimated that the success rates after the third attempt reach almost 90% in most cases.

Many factors play an important role in the success of the procedure: adequate evaluation and preparation of both donors and recipients, optimal synchronization between them, high laboratory standards and well-trained scientific staff, will all have a positive impact on pregnancy rates in an egg donation program.

Risks of egg donation 

1) For the donor:

Egg donation is a very safe procedure. Nevertheless, it is not entirely risk-free. Medicines taken to stimulate the ovaries, oocyte retrieval and the anesthesia required are all possible sources of complications. Briefly, the side effects of medications are usually mild, as one of the most feared complications in assisted reproduction, ovarian hyperstimulation syndrome is very rare in these cases. The remaining risks are estimated as follows: anesthesia risks: 1 / 10,000; risk of severe bleeding from oocyte retrieval: 1 / 2,500; risk of infection: less than 1/500.

It should be noted that the fertility of women who become egg donors is in no way affected. In fact, the eggs donated would have been otherwise discarded by their bodies.

2) For the recipient:

The possibility a donor transmits an infectious disease to the recipient is virtually non-existent, provided that proper evaluation of the egg donor has been performed, as dictated by the Greek law.

The most common risk for the recipient is the occurrence of a multiple pregnancy (twins) if more than one embryo is transferred. In any case, in egg donation cycles, the transfer of more than two embryos is strictly forbidden by the Greek law. If the couple is opposed to the possibility of a twin pregnancy, then only one embryo may be transferred (single embryo transfer, SET).

Pregnancy complication risk in recipiens with advanced age should be assessed individually for each case.

3) For the child:

To date, thousands of children have been born with this procedure, and the available data is reassuring, and equivalent to that of conventional IVF: the rate of birth defects is the same as the general population.

THE LEGISLATION IN GREECE 

On Egg Donation

  • Egg donation is an altruistic act, voluntary and with no financial benefit. Donors are compensated only for the working days they lose as part of the donation process and their travel expenses.
  • Donation of ova and sperm is allowed in Greece provided donor anonymity is ensured.
  • Egg donation is not allowed to women over 50 years old.
  • Donors must sign an oocyte concession consent.
  • Recipients sign a document stating that they are married and accept to undergo in vitro fertilization with egg donation. If they are not married, they should sign a notary act stating that they wish to undego IVF using the egg donation method.

On Assisted Reproduction

On January 27 2005, the law 3305/2005 on the application of assisted reproduction techniques was reported.

The Greek law on medically assisted reproduction is one of Europe’s most flexible. It safeguards the couple who wants to have a child based on medical, biological and bioethical principles. Its main purpose is, ultimately, the protection of the child to be born.

Basic principles of the current legislation

Some of the key points of the in-force law are the following:

1) Assisted reproduction methods are legal and allowed for women up to the age of 50 years, as this is considered the limit for natural conception.

2) The donation of ova and sperm is permitted, but the consent of the spouse or partner is also required.

3) Pre-implantation genetic diagnosis is allowed with the purpose of diagnosing whether the resulting embryos are carriers of genetic diseases. Consent of the concerned individuals is required.

4) Sex selection is prohibited unless a serious sex-related hereditary disease is avoided.

5) Cloning for reproductive purposes is prohibited.

6) Cryopreservation of genetic material or fertilized eggs is permitted.

7) The use of a gestational carrier (surrogacy) is allowed. A surrogate is a woman who carries a pregnancy for another couple or woman, who wishes to have a child but is unable to get pregnant for medical reasons. The surrogate woman must undergo medical and psychological examination. There should be no financial transaction other than the costs resulting from pregnancy exams, loss of work, etc. The procedure requires a special permit from a judge.

8) Assisted Reproduction Units are established and operate with the permission of the competent Authority, which shall give its agreement and verify that the legal requirements are met. For any violation, it sets administrative and criminal penalties.

9) The law sets age limits for sperm donors (younger than 40 years old) and egg donors (younger than 35 years).

10) Single women are allowed to conceive with assisted reproduction.

11) Donors must undergo clinical and laboratory testing and are not admitted to donation programs if they suffer from hereditary, genetic or infectious diseases. The use of fresh semen from donor is not permitted; only frozen semen may be used.

 

More info at gofertile.eu

PHTHALATES LINKED TO PREGNANCY LOSS -AND OTHER HEALTH PROBLEMS

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A recent study came -again- to incriminate certain environmental toxins known as phthalates as being responsible for pregnancy losses. Women undergoing assisted reproduction techniques (in-vitro fertilization or intra-uterine insemination) had urine exams to assess the presence of certain phthalates; it became evident that women with high levels of phthalates had up to three times increased risk of pregnancy loss. The study was recently presented at the Annual Meeting of American Society for Reproductive Medicine (ASRM).

For several years now we have been hearing about the toxic effects of phthalates, but what are they exactly? Where do we find them? Are they really harmful? Check out this article to learn more about these enigmatic toxins…

What are Phthalates?

Phthalates are chemicals used to soften plastics and make them more flexible (they are also known as plasticizers). These substances do not bound to plastics, therefore they are continuously released into the air, foods or liquids. Certain phthalates are used as dissolving agents for other materials.

Where do we find them?

Phthalates are used in an astounding array of products. They are most commonly found in:

  • Plastic bottles.Phthalates plastic bottles
  • Plastic containers and plastic wraps.
  • Cosmetics: in creams and lotions (to help them penetrate and soften the skin), in perfumes (to help them last longer), in hair sprays (to reduce stiffness), in nail polish (to prevent chipping), in deodorants, soaps, shampoos and almost every cosmetic with fragrance, including baby products.
  • Household products: air fresheners, paints, plastic flooring.
  • Plastic toys and other baby products such as teethers.
  • Certain medical devices, e.g., blood bags, intubation tubes, intravenous catheters.
  • Objects made of vinyl or PVC.
  • Phthalates are present even in seemingly unexpected sources. One example is milk: even in glass bottles, high levels of phthalates have been found, presumedly due to the plastic tubing used in milking machines.

We get exposed to phthalates by:

  • Ingestion: eating food contaminated from food packaging; drinking beverages from plastic bottles that leach the chemical; sucking plastic objects (e.g., baby toys, teethers).
  • Absortion: using cosmetics products. According to the CDC, women of childbearing age have the highest levels of phthalates, possibly due to the use of cosmetics.
  • Inhalation: breathing dust or fumes from products containing vinyl (vinyl floors, the interior of cars, shower curtains, etc).

Which are the most commonly used phthalates?

Phthalates perfumeThese chemicals have very difficult names, but there are a few you may want to keep in mind (see the studies below):

-In cosmetics: the primary phthalates used in cosmetic products have been dibutylphthalate (DBP), used in nail polishes; dimethylphthalate (DMP), used in hair sprays; and diethylphthalate (DEP), used as a solvent and fixative in fragrances. According to latest survey of cosmetics conducted by the Food and Drug Administration (FDA) in 2010, DBP and DMP are being used rarely, while DEP is the most commonly used phthalate. The use of DBP and DEHP is banned in the European Union  but they are still found in cosmetic products.

-In food packaging: the most commonly used is Di-(2-ethylhexyl) phthalate (DEHP). Bisphenol-A (BPA) is not a phthalate, but is also being used as plasticizer in food packaging and plastic bottles.

-In paints, plastic and PVC objects, solvents and adhesives: DEHP, Diisobutyl phthalate (DIBP) and DBP (also called DnBP).

-In children toys and child care products: In the USA, phthalates used in these products have been divided in three categories:Phthalates toy ducks

  1. permanent ban (permanently prohibits the sale of any “children’s toy or child care article” individually containing concentrations of more than 0.1% of DBP, BBP or DEHP);
  2. interim ban (prohibits on an interim basis the sale of “any children’s toy that can be placed in a child’s mouth” or “child care article” containing concentrations of more than 0.1% of DNOP, DINP, or DIDP); and
  3. currently unrestricted under Section 108 of the Consumer Product Safety Improvement Act of 2008 (DMP, DEP, DIBP, DCHP, DIHEPP, DIOP, DPHP).

Similar recommendations apply in Europe, where the six above-mentioned products are banned.

What is the evidence linking phthalates to pregnancy losses?

In addition to the recent American study (where they measured metabolites of DEHP), two previous studies had found a relationship between phthalates and miscarriages:

In 2012, a Danish study  found an increased risk of early pregnancy loss in women with high urine levels of DEHP‘s breakdown products. More recently, a Chinese study, comparing urine samples of women who had miscarriages and healthy women found that pregnancy loss was associated with higher levels or three phthalates: DEP, DBP, and di-isobutyl phthalate (DiBP).

Another American study also found and increased risk of miscarriages in women with high levels of BPA.

Eliminating phthalates and BPA from our lives is virtually impossible, but you can take some measures to minimize exposure, especially if you are trying to conceive, are pregnant or have young children”

Are there any other health risks?

Phthalates are widely known as endocrine disruptors: they mimic hormones, interfering with their function. Some possible consequences of this are:

Effect on male fertility: phthalate exposure in men was associated with reduced fecundity.

Birth defects in baby boys: several studies have found abnormalities in baby boys’ genitals when pregnant women were exposed to high levels of certain phthalates; another study found increased risk of hypospadias (the opening of the urethra is on the underside of the penis) in occupational exposure of pregnant women.

Neurological problems in newborns, infants and children: such as attention deficit hyperactivity disorder (ADHD), reduced IQ, behaviour problems.

Obesity: both in children and adults.

Asthma: in children when pregnant women were exposed to high level of phthalates.

Interference with puberty in girls: the evidence is inconsistent on this subject; while some studies found that phthalates may be related with precocious puberty, others reported delayed puberty.

Breast cancer: a small study showed increased breast cancer risk, but the evidence is not conclusive; there is a large study being conducted in the USA, which will provide more clear answers on this matter.

What can I do to reduce exposure to phthalates?

Phthalates glass food containersEliminating phthalates and BPA from our lives is virtually impossible -they seem to be everywhere- but you can take some measures to minimize exposure, especially if you are trying to conceive, are pregnant or have young children:

  1. Read labels on personal care products. Unfortunately, manufacturers are not forced to list phthalates, and  they can be added as a part of the “fragrance.” Many companies have voluntarily removed phthalates from their products, so you may search for products labelled as “phthalate-free”.
  2. Limit the use of baby care products in babies and young children.
  3. Don’t microwave food in plastic, or use only “microwave safe” and phthalate-free containers to microwave food or drinks. Phthalates can leach from containers (or plastic wrap) into foods on contact and when heated, particularly oily foods or with a high fat content. Don’t put plastic containers in the dishwasher (heat will increase phthalates leaching).
  4. Replace plastic bottles, cups, dishes and food containers with those made of glass, porcelain or stainless steel, especially for hot food and beverages.
  5. Check labels on plastic bottles and containers: choose only those with recycle codes 1, 2, 4, or 5. Plastics made of polyethylene terephthalate (PET) or high-density polyethylene (HDPE) are safer than those made of PVC (“PET” or “HDPE” may be printed on the label or the bottom of the bottle).
  6. Use only toys and toothbrushes labeled “phthalate- free”. There are strict regulations banning the most dangerous phthalates in toys and baby products, both in the USA and in Europe.
  7. Reduce your use of canned foods, as they are often lined with material that contains BPA. Prefer fresh products or those in glass containers. Avoid canned milk (including canned formula for babies).
  8. Phthalates baby bottlesChoose only bottles and cups that are BPA-free. In fact, BPA was banned in all baby products in 2011 in Europe, and since 2012 in the USA.
  9. When using paints or solvents, keeps the area well ventilated. Prefer natural paints, phthalate-free (DBP is the phthalate usually used in these products).
  10. Choose non-vinyl products, such as shower curtains, raincoats or furniture, as the chemical off-gassing from these products introduces phthalates to your environment.
  11. Keep your house clean, as phthalates can remain in dust.
  12. Avoid air fresheners; prefer essential oils instead.

Is anything being done?

Phthalates safe cosmeticsAs people are becoming more aware of the harmful effects of phthalates, increasing information is being available to consumers; websites such as the Campaign for Safe Cosmetics have actively advocated the elimination of dangerous chemicals from cosmetics and personal care products. As a result, certain companies and retailers have been taking measures to reduce toxic substances in their products.

Initiatives are also being taken at governmental level. European authorities have restricted the use of phthalates in some baby products, cosmetics, and plastics designed to come into contact with food; more phthalates will be soon banned from medical equipment, electrical and electronic devices. Recently, a very extensive Report to the U.S. Consumer Product Safety Commission by the Chronic Hazard Advisory Panel on Phthalates and Phthalates alternatives (CHAP) analyzed the available data on each phthalate and phthalates alternative and provided recommendations, which will hopefully lead to banning certain phthalates that proved to be toxic.

 

Photo credits

Getty Images; Reciclado creativo, Flickr.com; Etienne, Flickr.com; Pixabay.com; Target.com; Alicia Voorhies, Flickr.comjillsamter.com

THE HPV VACCINE: WHY IS IT CONTROVERSIAL?

The HPV vaccine has been around for almost 10 years and more than 175 millions doses have been distributed in 63 countries, with several studies confirming its safety and efficacy. In spite of that, the vaccine still remains a subject of controversy. Although recommended by most scientific societies worldwide, some recent reports questioning its safety fuelled even more the debate, dividing both general public and medical community.

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In this article we will analyse the existing evidence regarding the HPV vaccine, with particular focus on its efficacy and safety. In order to organise the available information, the article will be divided into the following sections:

  1. Getting to know HPV
  2. Why a vaccine? The burden of HPV-related diseases
  3. The three available HPV vaccines
  4. Vaccination schedule and timing 
  5. Efficacy of the HPV vaccine
  6. Safety of the HPV vaccine
  7. Recent safety concerns: the chronicle of events
  8. Other debatable issues
  9. Unanswered questions…
  10. Conclusion

1. Getting to know HPV

HPV vaccine cure cancer awarenessHPV (human papillomavirus) is a virus and is transmitted from person to person through skin-to-skin contact.

  • HPV infection is extremely common, and most of the times it will be cleared by the immune system.
  • Of the over 100 types of HPV, about 12 subtypes of the HPV (mostly subtypes 6 and 11) may cause genital warts (also known as condylomas). These so-called “low-risk types” can also cause a rare condition called recurrent respiratory papillomatosis, in which warts grow in the throat.
  • Approximately 15 types of HPV (most commonly types 16 and 18) are related to cancer. While cervical cancer is the most common HPV-related cancer, this virus can also cause other cancers: vulvar, vaginal, anal and oropharyngeal (mouth and throat),  as well as penile cancer in men.

You can read more detailed information on HPV here.

 

2. Why a vaccine? The burden of HPV-related diseases

HPV vaccine every 2 minutes a woman diesThese figures will give you and idea of the magnitude of the problems caused by HPV:

-Worldwide, over 500,000 new cervical cancer cases are diagnosed annually. Cervical cancer ranks as the 4th cause of female cancer in the world and is the 2nd most common female cancer in women aged 15 to 44 years (1).

In the United States, an estimated 26,000 new cancers are attributable to HPV each year, about 17,000 in women and 9,000 in men (2) .

In Europe, about 58,000 new cases of HPV-related cancers are estimated to occur every year (3).

-Regarding  precancerous lesions, the estimated annual burden of high-grade precancerous lesions ranges between 280,000 and 550,000 new cases per year in Europe (4).

-In addition to cancers and precancerous lesions, the problem of genital warts should also be taken into consideration. Genital warts are very common: 1 out of 10 persons will have condylomas at some point in their lives (the frequency varies according to different countries between 0,3 and 12 %) (5). About 800,000 new annual genital warts cases are estimated to occur in women and men in Europe (4). Although not life-threatening, the costs derived from their treatment and their psychological burden should not be neglected.

 

3. The three available HPV vaccines

HPV vaccine collageFrom 2006, 2 vaccines have been available: One bivalent (Cervarix®), directed against HPV types 16 and 18, responsible for about 70% of cervical cancers  and other HPV-associated cancers; the other quadrivalent (Gardasil® of Silgard® in different countries) containing 4 HPV types:16 and 18, together with HPV 6 and 11 which are responsible for more than 90% of genital warts.

In December 2014, the American Food and Drug Administration (FDA) approved a nine-valent vaccine, Gardasil 9® (6), which, besides the 4 strains contained in Gardasil (i.e., 6,11,16,18), includes types 31, 33, 45, 52, and 58, responsible for an additional 20% of HPV-related cancers (4). Gardasil 9 has also been recently approved for commercialisation in Europe (7).

 

4. Vaccination schedule and timing 

HPV vaccine who should get it ACIPinfographic

  • Vaccines are given as a 3-dose series, Gardasil at 0, 2 and 6 months, Cervarix at 0, 1 and 6 months (8).
  • In the States, The Advisory Committee on Immunization Practices (ACIP) and  the American College of Obstetrician and Gynecologists (ACOG) recommend that girls be routinely vaccinated at age 11 or 12 years.
  • Since 2010 boys have been included in the vaccination schedule in the USA, with the same schedule as girls.
  • If not vaccinated when they were younger, girls/young women and boys/young men should be vaccinated through age 26 (9).
  • Vaccine may be given starting at age 9 years (9, 10).
  • A reduced, 2-dose schedule is recommended by the World Health Organization (WHO) for those aged 9-13 years; this schedule is not recommended by the ACIP but it has been adopted by many countries.HPV vaccine Protect your children
  • Earlier vaccination (before age 14) results in higher immune response. Another argument in favor of early vaccination is the fact that vaccines are more effective before the onset of sexual activity (8).
  • Vaccination is recommended regardless of sexual activity or known HPV infection. Although vaccines seem to be less effective in sexually active people, some benefit is expected to be attained since exposure to all types of HPV included in the vaccines is very unlikely. Testing for HPV is NOT recommended before vaccination.
  • The vaccines are prophylactic, that is, they do not prevent progression of existing infection to disease or treat existing disease. (2)
  • The HPV vaccine is covered by most private health insurance and government insurance programs worldwide. Vaccinations schedules may vary in different countries.
  • There seems to be additional protection by the vaccine in women through age 45, as showed by certain studies (11). However, there is no recommendation for vaccination in individuals aged 26 to 45.
  • The same schedule applies for Gardasil 9 (0, 2 and 6 months). Revaccination with the nine-valent vaccine is not recommended in persons who previously completed the three-dose series with the bivalent or or quadrivalent HPV vaccine (8).

5. Efficacy of the HPV vaccine

HPV Vaccine Charlene-Choi1The ultimate goal of the HPV vaccine is to reduce the incidence of HPV-related cancers. For obvious ethical reasons, the endpoint set to evaluate the HPV vaccine efficacy in different studies was precancerous lesions, namely CIN 2 and 3 (high risk lesions of the cervix, with potential to evolve to cancer). Other efficacy endpoints evaluated were incidence of HPV infection and incidence of condylomas.

Studies conducted before licensure showed that both vaccines achieved a high level of protection: 98-100% for the HPV types included in the vaccine in a naive population (that is, women who did not have HPV 16 or 18 at the time of  vaccination),  although the protection against precancerous lesions was 30-40% in the total vaccinated cohort (which included women who did not finish their immunization plan, or that were already infected with the virus before vaccination) (12, 13, 14, 15). There was also cross-protection for other types of HPV (i.e., HPV 45 and 31), which was more intense with Cervarix (16).

HPV vaccine AustraliaThe impact of vaccination on the general population has also been analysed in some studies. Australia was the first country to introduce an organised HPV vaccination program, achieving one of the world’s highest vaccination compliance rates.  Since 2007, when the National HPV vaccination program started with the quadrivalent vaccine, HPV infections from the types included in the vaccine decreased from 29% to 7% (17); a 93% reduction in the diagnosis of genital warts was also observed (18). Moreover, other recent studies showed an almost 50% reduction of  high-grade cervical precancerous lesions in women who had received all required doses of the vaccine (19).

Denmark also counts with an organised vaccination program. Six years after licensure of the quadrivalent HPV vaccine, a reduction of cervical precancerous lesions was observed, which was 80% in younger patients (20).

Recently, a study was conducted to evaluate the efficacy of the nine-valent vaccine. Gardasil 9 prevented 97% of high-grade precancerous lesions of the cervix, vulva, and vagina caused by the five new high-risk HPV types (HPV31/33/45/52/58) (21). The nine-valent vaccine also generated immune responses to HPV6/11/16/18 that were as good as or better than those generated by the quadrivalent vaccine. (4, 22)

 

6. Safety of the HPV vaccine

Many studies have evaluated HPV vaccine safety, both before their commercialisation and post-release, which demonstrated no differences in side effects as compared to control groups, irrespective of age and ethnicity (23).

HPV vaccine armed against cancerAccording to the CDC, the most commonly reported side effects of the vaccines are:

  • Pain, redness, or swelling in the arm where the shot was given
  • Fever
  • Headache or feeling tired
  • Nausea
  • Muscle or joint pain

Fainting (also known as syncope) and related symptoms (such as jerking movements) is not uncommon (24), especially in teenagers. For that reason, it is recommended that people receiving the HPV vaccine sit or lie down during vaccination, and remain seated for 15 minutes after the shot. (23)

Considering the target age of vaccination (which includes women in reproductive age), pregnancy outcomes received special attention. No increase in miscarriage rates has been reported for either of the vaccines (25). In addition, pregnant women that were recorded and observed in registrative trials did not have increased rate of congenital abnormalities (26, 27, 24).

Studies have also demonstrated efficacy and safety of the vaccines in men, both in heterosexual and men who have sex with men (28).

Serious side effects are very rare (less than 0.5%) (29), the most common being persistent headache, hypertension, gastroenteritis, bronchospasm and anaphylaxis. Their reported incidence is similar to that of other compulsory vaccines types (30).

HPV vaccine third pokeCertain side effects have been a matter of concern since the introduction of the vaccine, namely autoimmune diseases (AD) (i.e., hypothyroidism, rheumatoid arthritis, Behçet’s syndrome, Raynaud’s disease, type 1 diabetes, and vitiligo), neurological disorders (such as epilepsy, paralysis, Guillain–Barré syndrome, central demyelination, and multiple sclerosis) and venous thromboembolism (a blood clot that plugs a vein). It should be mentioned that ADs are not rare in adolescents and young adults, particularly in women. Therefore, it is a real challenge to distinguish causal from temporal association. A recent study gathered the results of 9 large studies (of which one was an analysis of 42 trials together, or metanalysis) in order to investigate severe adverse reactions after the HPV vaccine. None of the included studies found evidence of increased risk of autoimmune disease, neurological disorder, or venous thromboembolism (31).

The Global Advisory Committee on Vaccine Safety (GACVS), established by the World Health Organization (WHO) provides independent, scientifically rigorous advice on vaccine-safety issues. In December 2013, the committee reviewed different topics and considered all available evidence on the safety of HPV vaccines, and concluded that both commercially available vaccines are safe (32). Likewise, the International Federation of Gynecology and Obstetrics (FIGO) Gynecologic Oncologic Committee and Subcommittee for Cervical Cancer Prevention support the continued administration of the HPV vaccines in appropriate populations (33).

7. Recent safety concerns: the chronicle of events 

HPV vaccine Japanese_SchoolgirlsAlthough some isolated cases of side effects had been described in UK and Australia (34), Japan was the first country reporting on several girls suffering from severe pain and disability; these cases were heavily publicised in newspapers, TV news and social media, but they also alarmed the medical community. Japanese physicians published later on a series of 44 girls who were diagnosed with complex regional pain syndrome (CRPS) (35). Due to these concerns, in June 2013 the Japanese Ministry of Health, Labour, and Welfare (MHLW) decided to suspend its active recommendation of HPV vaccination. This decision created intense debate among scientists and general public, which continues until nowadays (34).

In March 2015, Denmark‘s TV channel TV2 aired a documentary entitled The Vaccinated Girls – Sick and Betrayed. The journalists gathered about 60 girls from all over Denmark who became sick shortly after receiving the HPV vaccine. Among the doctors interviewed is Louise Brinth, who examined approximately 80 girls with similar symptoms potentially caused by the HPV vaccine. Dr. Brinth noted that the girls experience symptoms such as dizziness, passing out, and severe headaches. She said, “They have abdominal pain and nausea. They have weird muscle movements they cannot control. And they’re very tired… We see a pattern that screams to heaven, and that should be examined by some solid research.”

HPV vaccine Danish documentaryIn April 2015, Dr. Brinth reported in a scientific journal on 53 patients complaining of orthostatic intolerance, severe headache, excessive fatigue, cognitive dysfunction, gastrointestinal discomfort and widespread pain. Most of them were diagnosed with a rare syndrome known as postural orthostatic tachycardia syndrome (POTS), and all of them were in close temporal association with the HPV vaccine (36a, 36b).

Denmark’s documentary has had a huge impact worldwide, both in the general public and the medical community. A closed Facebook page set up for suspected victims of adverse reactions to Gardasil in Denmark tripled its -careful verified- members; similar Facebook groups were created in other countries.

At the request of Denmark, The European Medicines Agency (EMA) is currently conducting a safety review of HPV vaccines. However, the agency emphasizes that this review “does not question that the benefits of HPV vaccines outweigh their risks.”The agency also notes that while the review is being carried out, no change in the use of these products is recommended. See the EMA’s review conclusions here.

HPV vaccine reactions independent UKIn May 2015, UK’s newspaper The Independent published an article entitled: Thousands of teenage girls report feeling seriously ill after routine school cancer vaccination. The article focuses on the story of Emily Ryalls, 17, who started feeling intense pains and difficulty breathing soon after receiving the HPV vaccine.

Mrs Ryalls reported Emily’s symptoms to the Medicines and Healthcare Products Regulatory Agency (MHRA), and she was not alone: adverse reactions after HPV vaccination numbered 8,228, of which 2,587 were classified as “serious”; that’s substantially more that those reported with other compulsory vaccines (see graph). The MHRA, though, said it had no concerns on the numbers of adverse reactions related to the HPV vaccine and that the “expected benefits in preventing illness and death from HPV infection outweigh the known risks”.

Emily’s mother, together with other 80 families in similar situation across the UK have formed the Association for HPV Vaccine Injured Daughters (AHVID).

As stated by the newspaper “This article created significant debate among medical professionals, journalists and members of the public…”.

HPV vaccine France fiasco SV-1136-vaccin-HPVIn France, the National Security Agency of Medicines and Health Products (ANSM) just published (September 2015) the results of the follow-up of more than 2 million girls aged 13-16 years, vaccinated between 2008 and 2013 to evaluate the occurrence of side effects, mainly autoimmune diseases. When analysed all the diseases together, their results showed no overall increased risk of occurrence of serious events. However, when each disease was analysed individually, a four-fold increase in the occurrence of Guillain Barre syndrome was observed. The study also found an increased risk of Inflammatory Bowel disease, but the association was weak.

The authors conclude: “…the results of the study… prove reassuring regarding the risk of autoimmune disease associated with the HPV vaccines. The expected benefits of this vaccination in terms of public health are far greater than the eventual risks the girls may be exposed to” (37). In spite of these “reassuring” results, the vaccination rate in France continue to be low (less than 30%).

HPV vaccine POTSIn September 2015, another report provided details on 45 individuals from 13 countries who developed a chronic ailment soon after receiving the HPV vaccine. “A disabling syndrome of chronic neuropathic pain, vexing fatigue, and profound autonomic dysfunction may appear after HPV vaccination,” say the authors, headed by Manuel Martínez-Lavín, MD, a specialist in chronic pain conditions from Mexico City. After a mean period of 4 years following HPV vaccination, 93% of individuals “continue to have incapacitating symptoms and remain unable to attend school or work,” write the authors (38).

POTS after HPV vaccination has also been reported in the United States.  Dr. Blitshteyn, a neurologist from New York, described six patients who developed POTS between 6 days and 2 months after HPV vaccination. All patients reported improvement over 3 years, but residual symptoms persisted (39).

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) emphasised that controlled clinical trials in tens of thousands of individuals plus postlicensure monitoring of millions of individuals have found no causal association between HPV vaccination and atypical pain syndromes or autonomic dysfunction.

HPV vaccine Diane HarperDr. Diane Harper, an american obstetrician & gynecologist, is one of the HPV experts called in to design the clinical trials of Gardasil and Cervarix.  Although initially in favour of the vaccine, in recent years she has questioned Gardasil safety. She stated that “Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year”. Moreover, in an article published in December 2009 she concluded that, given the various limitations and risks of the vaccines, the benefits and risks of HPV vaccination must be weighed with the benefits and risks of HPV screening (Pap smears) to reduce cervical cancer in a cost-effective manner (40).

Dr. Harper does not support mandatory HPV vaccination for schoolchildren, because she believes that the duration of protection may be too short (see below). She has also criticised the short period of time vaccines were tried before its licensure,  and the misleading publicity carried out by the pharmaceutical companies. Learn more here.

8. Other debatable issues

Vaccination in boys

HPV vaccine is cancer prevention.

The rationale of vaccinating boys is to reduce the transmission of the HPV virus to women and to protect them against oral and anal cancers (41). Since these cancers are very rare, it has been questioned by some scientists whether is it worth to expose millions of boys to potential vaccine side effects in order to protect girls, or to prevent a so rare type of cancer (responsible for just 300 deaths in the USA); whether the benefit outweighs the risk and if men vaccination is cost effective. While countries such as Australia and the USA include boys in their vaccine recommendations, other countries (i.e., UK and France) have not yet adopted this measure.

Men who have sex with men are a special category, since they are at higher risk of anal cancer. Thus, some experts believe these men (and not every boy) should be offered the vaccine. However, this measure may be difficult to implement: in order get covered by their insurance or social security, young men may be required to declare their sexual preferences.

Immunogenicity of Gardasil vs. Cervarix

HPV vaccine ArgentinaImmunogenicity means the ability of the vaccine to provoke an immune response; in other words, the “strength” of the vaccine.

Most countries adopted vaccination with Gardasil instead of Cervarix assuming equal protection for cancer, with the “bonus” protection against genital warts. But is it really like this?

Several studies have demonstrated that Cervarix elicits stronger and longer-lasting immune response than Gardasil (42, 43).

These laboratory findings have also been confirmed by some clinical studies: Over the years, the efficacy of the Cervarix to protect vaccinated women from precancerous lesions (total vaccinated cohort-naive) was 93%, while Gardasil’s dropped to 43% (44)

Age of vaccination

HPV vaccine school girlThis subject has also raised intense debate and concern. As stated above, immune response provoked by the vaccines may be of limited duration, especially for Gardasil. This can be a serious limitation of the vaccine because, as Dr. Harper noted “… if the HPV vaccine does not last for at least 15 years, no cancers will ever be prevented; women will just get the cancers at a later time in life after the vaccine has worn off“.

If this short protection span is confirmed by clinical studies, a boost dose would solve this limitation. However, this would increase considerably the cost of the vaccine; moreover, women who don’t comply with this recommendation will become unprotected over time.

Increase of promiscuity?

Many people feared that the the HPV vaccine would lead girls to promiscuous behavior. This was actually investigated by some studies, and have proved not to be true: no increase in sexually transmitted diseases was observed among vaccinated girls (45), showing that vaccination is unlikely to promote unsafe sexual activity.

9. Unanswered questions…

  • HPV cancer vaccine flyer - 8-1/2 x 11Will the HPV vaccine reduce cervical cancer deaths in real-world conditions?
  • In light of the latest publications, should vaccination programs be halted until the situations is clarified?
  • Due to these latest concerns, will more women opt for no vaccination, missing the opportunity to be protected against cancer?
  • Since the syndromes potentially related to vaccines are difficult to diagnose, is it possible that they have been underreported in the past? Could they possibly become over reported in the future?
  • Will the vaccine create a false sense of full protection against cervical cancer, resulting in less women attending screening programs?
  • Will the vaccine lead to a reduction of the HPV types included in the vaccine, but to an increase of those not included in the vaccine?

10. Conclusion

HPV vaccine End-cervical-cancer-posterIt is indeed exciting to have a vaccine that protects against cancer. After seeing women dying from cervical cancer, I truly wish that cervical cancer will be eradicated in the future. But we MUST be sure that we don’t create more harm than good in the process.

HPV vaccine smear for a smear campaignI am in favor of vaccines. Vaccines have done a lot of good to humanity (just imagine if we would still have small pox, or poliomyelitis…). It is true that every single medical practice may come with side effects, and this include vaccines. But we MUST know exactly what are the vaccine risks, and whether the benefits outweigh the risks.

I firmly believe that governments, scientific societies and pharmaceutical companies MUST do an effort to inform people in a responsible and honest manner, so that all of us -young people, parents and physicians- continue to believe in good science, and vaccines don’t lose their credibility.

It will take 10 to 20 years to figure out the true benefit of the HPV vaccine. In the meantime, keep in mind that Pap tests never killed anyone, on the contrary, they have saved millions of lives. Therefore, don’t forget your Pap smear!

 

Read on the latest events related to the HPV vaccine here.

 

References

  1. International Agency for Research on Cancer, World Health Organization. Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012
  2. CDC Grand Rounds: Reducing the Burden of HPV-Associated Cancer and Disease. Morbidity and Mortality Weekly Report (MMWR) January 31, 2014 / 63(04);69-72
  3. Human Papillomavirus and Related Diseases Report. hpvcentre.net March 20th, 2015
  4. Hartwig S, et al: Estimation of the epidemiological burden of HPV-related anogenital cancers, precancerous lesions, and genital warts in women and men in Europe: Potential additional benefit of a nine-valent second generation HPV vaccine compared to first generation HPV vaccines. Papillomavirus Research, In Press (Available online 16 June 2015)
  5. Patel H, et al: Systematic review of the incidence and prevalence of genital warts. BMC Infectious Diseases 2013, 13:39
  6. “FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV” (press release). 10 December 2014.
  7. Gardasil® 9: new HPV vaccine approved in the European Union. The European Commission grants marketing authorisation for the first 9-valent HPV vaccine” (press release) Sanofi Pasteur MSD, June 17, 2015.
  8. Human Papillomavirus Vaccination. The American College of Obstetricians and Gynecologists, Committee Opinion Number 641, September 2015
  9. Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males — Advisory Committee on Immunization Practices (ACIP), 2011. Morbidity and Mortality Weekly Report (MMWR), December 23, 2011 / 60(50);1705-1708
  10. Markowitz L, et al: Quadrivalent Human Papillomavirus Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report (MMWR), March 23, 2007 / 56(RR02);1-24
  11. Castellsagué X, et al: HPV vaccination against cervical cancer in women above 25 years of age: key considerations and current perspectives. Gynecologic Oncology 115 (2009) S15–S23
  12. Villa L, et al: Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol 2005; 6: 271–78
  13. The FUTURE II Study Group: Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. N Engl J Med 2007;356:1915-27
  14. Paavonen J, et al: Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet, Vol 374, No. 9686, p301–314, 25 July 2009
  15. Lehtinen M, et al: Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol, Vol 13, No. 1, p89–99, January 2012
  16. Harper D: Prophylactic human papillomavirus vaccines to prevent cervical cancer: review of the Phase II and III trials. Therapy 2008, 5 (3), 313-324
  17. Tabrizi SN, et al: Fall in human papillomavirus prevalence following a national vaccination program. J Infect Dis. 2012; 206(11):1645-1651
  18. Mariani L, et al: Early direct and indirect impact of quadrivalent HPV (4HPV) vaccine on genital warts: a systematic review. Adv Ther, 32 (2015), pp. 10–30
  19. Crowe E, et al: Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia. BMJ 2014;348:g1458 
  20. Baldur-Felskov B, et at: early impact of Human Papillomavirus Vaccination on cervical Neoplasia—Nationwide Follow-up ofYoung Danish Women. J Natl Cancer Inst (2014) 106(3): djt460 doi:10.1093/jnci/djt460
  21. Joura E, et al: A 9-Valent HPV Vaccine against Infection and Intraepithelial Neoplasia in Women. N Engl J Med 2015; 372:711-723
  22. Petrosky E, et al: Use of 9-Valent Human Papillomavirus (HPV) Vaccine: Updated HPV Vaccination Recommendations of the Advisory Committee on Immunization Practices. Morbidity and Mortality Weekly Report (MMWR), March 27, 2015 / 64(11);300-304
  23. Center for Disease Control and Prevention. Human Papillomavirus (HPV) Vaccine Safety. Updated September 28, 2015
  24. Slade BA, et al: Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA, 2009;302(7):750–757
  25. Wacholder S, et al: Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ 2010;340:c712
  26. Garland SM, et al: Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol 2009;114(6):1179–1188
  27. Dana A, Buchanan KM, Goss MA, et al. Pregnancy outcomes from the pregnancy registry of a human papillomavirus type 6/11/16/18 vaccine. Obstet Gynecol. 2009;114(6):1170–1178
  28. Moscicki A, et al: HPV in men: an update. J Low Genit Tract Dis. 2011 Jul; 15(3): 231–234
  29. Gonçalves AK, et al: Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review. Braz J Infect Dis, Vol 18, Issue 6, Nov–Dec 2014, Pages 651–659
  30. Lu B, et al: Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review and meta-analysis. BMC Infect Dis. 2011;11:13
  31. De Vincenzo R, et al: Long-term efficacy and safety of human papillomavirus vaccination. International Journal of Women’s Health 2014:6 999–1010
  32. World Health Organization. Global Advisory Committee on Vaccine Safety, 11–12 December 2013: Human papillomavirus vaccines safety (HPV). Wkly Epidemiol Rec. 2014;89(7):58–60
  33. Denny L: Safety of HPV vaccination: a FIGO statement. Int J Gynaecol Obstet. 2013;123(3):187–188
  34. Wilson R, et al: HPV Vaccination in Japan. The Continuing Debate and Global Impacts. A Report of the CSIS Global Health Policy Center. April 2015
  35. Kinoshita T, et al: Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls Following Immunization with the Human Papillomavirus Vaccine. Intern Med 53: 2185-2200, 2014
  36. a: Brinth L, et al: Suspected side effects to the quadrivalent human papilloma vaccine. Dan Med J 2015;62(4):A5064 b: Brinth L, et al: Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. Vaccine, 2015 May 21;33(22):2602-5
  37. Vaccination contre les infections à HPV et risque de maladies auto-immunes : une étude Cnamts/ANSM rassurante – Point d’information 13/09/2015
  38. Martínez-Lavín M, et: HPV vaccination syndrome. A questionnaire-based study. Clinical Rheumatology pp 1-3. Online 10 September 2015
  39. Blitshteyn S. Postural tachycardia syndrome following human papillomavirus vaccination. Eur J Neurol, Vol 21, 1, 135–139, 2014
  40. Harper, D: Current prophylactic HPV vaccines and gynecologic premalignancies. Current Opinion in Obstetrics and Gynecology 2009, 21:457–464
  41. Giuliano A, et al: Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males. N Engl J Med 2011;364:401-11
  42. Einstein M, et al: Comparative immunogenicity and safety of human papillomavirus (HPV)- 16/18 vaccine and HPV-6/11/16/18 vaccine: follow-up from months 12-24 in a Phase III randomized study of healthy women aged 18-45 years. Human Vaccines, vol. 7, no. 12, pp. 1343–1358, 2011
  43. Barzon L, et al: Neutralizing and cross-neutralizing antibody titres induced by bivalent and quadrivalent human papillomavirus vaccines in the target population of organized vaccination programmes. Vaccine, vol. 32, no. 41, pp. 5357–5362, 2014
  44. Di Mario S, et al: Are the Two Human Papillomavirus Vaccines Really Similar? A Systematic Review of Available Evidence: Efficacy of the Two Vaccines against HPV. Journal of Immunology Research, Volume 2015 (2015), Article ID 435141, 13 pages
  45. Jena A, et al: Incidence of Sexually Transmitted Infections After Human Papillomavirus Vaccination Among Adolescent Females. JAMA Intern Med. 2015;175(4):617-623

 

Photo Credits

Intro: Getty images; 1: curecancer.org; 2: m2.behance.net; 3: (collage) wikimedia commons; 4: cityofchicago.org; nkytribune.com; 5: english.cri.cnhpv.health.gov.au; 6: marketingmag.cascontent.cdninstagram.com; 7: Japan: wikimedia commons; Denmark: vaccineimpact.com; UK: independent.co.uk; France: science-et-vie.com; POTS: pinterest.com; Harper: initiativecitoyenne.be; 8: bphc.orgmigueljara.files.wordpress.comlh3.googleusercontent.com; 9: healthvermont.gov; 10: compasscayman.comi.dailymail.co.uk

PREGNANCY DO’S AND DONT’S (Part 2)

BEAUTY TREATMENTS AND MEDICATIONS

In a previous post on Pregnancy do’s and dont’s, we analysed what is allowed and what discouraged during pregnancy concerning food, beverages, alcohol and cigarette (see here). This second part will deal with beauty treatments and medications. A third part with more do’s and dont’s will follow…

BEAUTY TREATMENTS

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Pregnancy comes with many body changes: weight gain, swelling…. And on top of that, hormonal shifts causing mood swings… You want to look beautiful! But is it possible to be both pregnant and beautiful? Of course! You will just need to be a little bit more careful and avoid certain things, either because there is some concern that they may be harmful for you baby, or we do not have enough evidence to prove their safety. This guide will help you be both beautiful and safe…

  1. Artificial tanning
  2. Botulinum toxin (Botox)
  3. Essential oils
  4. Hair dye, perms and straightening treatments
  5. Hair removal
  6. Insect repellents
  7. Nail beauty
  8. Skin care and cosmetics
  9. Spa visits
  10. Sunscreens
  11. Teeth whitening

1. Artificial tanning

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Fake tan products are generally safe to use during pregnancy; they contain Dihydroxyacetone (DHA), which is not absorbed into the body when applied to the skin as cream, mousse or wipes. But avoid spray tans as the effects of breathing in the spray are not known.

You should stay away from tanning pills, they might be toxic to your baby (they are banned in several countries but they are sold online).

Solarium’s /Tanning Beds: we do not know whether they may affect the unborn baby, but they have been related to skin cancer, so better avoid them. The risk of overheating during pregnancy should also be considered (see below).

Anyhow, keep in mind that your skin is more sensitive while pregnant, therefore some products may cause skin irritations, or you may get burnt more easily.

2. Botulinum toxin (Botox)

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Botox injections, used to smooth wrinkles are not recommended in pregnancy, unless they are done for medical reasons. Although no risk has been demonstrated, there are no adequate studies to prove its safety. In any case, don’t worry on this one, your wrinkles will get naturally smoother as your pregnancy progresses!

3. Essential oils

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Essential oils are highly concentrated substances coming from plants. They are used in aromatherapy, either in massage or put in a vaporiser to breathe them in. While some essential oils are safe for use in pregnancy, other can be harmful, either by causing contractions, bleeding or eventually birth defects. Consequently, you should be extremely careful with their use, and always ask advise from your physician or someone specialised  in aromatherapy. For a more detailed list of essential oils allowed and discouraged in pregnancy, click here.

4. Hair dye,  perms and straightening treatments

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It is not clear whether the chemicals used for hair dying are completely safe during pregnancy, although the risks are likely to be low. Some studies have linked the use of hair dye with a rare type of cancer in babies (neuroblastoma); however, other studies have not corroborated this finding. To be extra cautious, it is usually advised to avoid them during the first trimester. To limit exposure to chemicals, you may prefer highlights. Vegetable dyes may be a good alternative, but be aware that many of those contain the same chemicals than the regular ones.

Regarding perms and straightening treatments, they seem to be safe during pregnancy. Again, it seems wiser to avoid them during the first trimester. You should better stay away from keratin treatments (also called Brazilian keratin treatments) as they contain formaldehyde which might be harmful to the baby (and to you).

  • There seems to be an increased risk of miscarriage in woman working at a hair salons. If you work at a hair salon and you cannot avoid exposure to chemicals, take the same precautions stated for nail salon workers (see below).

5. Hair removal

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There are no studies that evaluate the safety of electrolysis and laser. Electrolysis uses 2 types of currents, thermolysis and galvanic; while the former seems to be safe, galvanic electrolysis should not be used in pregnancy. Laser use during pregnancy has not been evaluated properly, although it seems to be safe. Most specialists will propose to avoid it throughout the whole pregnancy due to lack of information about its safety.

Waxing is safe and should be preferred to creams. Creams and depilatories contain barium sulfide powder and calcium thioglycolate. There is no evidence that they are harmful for pregnancy, but no studies have been conducted to prove their safety.

6. Insect Repellents

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When used as recommended, most insect repellents are considered safe during pregnancy. Since there are different types of active ingredients (pesticides) in insect repellents, read the label carefully. The chemical DEET (N, N-ethyl-m-toluaminde or m-DET) is the most effective and best studied product, and is very good at preventing mosquito and tick bites. Both animal and human studies found no increase in babies’ defects, survival, growth, or development in the first year of life. In any case, try to minimise exposure by using a product with the lowest concentration of DEET needed for your protection. When possible, apply the pesticide to your clothing rather than directly to your skin.

Some insect repellent products contain citronella oil. While the American Food and Drug Administration (FDA) considers citronella- containing repellents safe for use, in Europe citronella use is banned due to some concerns on toxicity.

7. Nails beauty

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Gel nails, shellac nailpolish, acrylic nails, nail art… so many ways you can adorn your nails… But are they safe? Let’s see in  detail…

Nail polish: it is fine to use nail polish every now and then. There are three, potentially toxic substances in nail polish: Dibutyl Phthalate (DBP), Toluene  and Formaldehyde. Of particular concern is DBP; the European Union has banned its use, but it is still being found in some nail polishes. Formaldehyde and Toluene should not be a problem if used occasionally, but it may be an issue for pregnant women regularly exposed to them, such as those working in a nail salon. If you want to be on the safe side, use chemical-free products and make sure you paint your nails in a very well ventilated room.

Nail polish remover: It is OK if you use it occasionally. It usually contains acetone, a substance naturally produced by our body (in very small amounts). If you are regularly exposed to large amounts of acetone, there is a slight possibility of increasing your changes of having a miscarriage or a baby with some birth defects. To play safe, you may use acetone-free products.

Acrylic nails: concerns have been raised both on the glue used to stick the nails, and on a substance the nails may contain (methylmetacrylate or MMA, now mostly replaced by a supposedly safer EMA). Again, it should not be a risk if you do it occasionally, in a very well ventilated area. Moreover, you should know that fake nails have been related to higher chances of getting bacterial and fungal nail infections or nail deformities.

Gel nails: gel nails are applied as a gel to the nail, and then set by a UV lamp, or by the application of a chemical. Like acrylic nails, they contain methacrylate monomers, which may be dangerous for pregnant and non pregnant women. In addition, the UV lights used to dry the nails have been linked to skin cancer. The other problem is their removal: you need to keep your hands for 20 minutes in acetone. While the small amount of acetone used to remove the common nail polish seems to be harmless, this extended exposure raises some concern. So, if possible, stay away from gel nails.

Shellac nail polish: Shellac is a resin secreted by a bug, which is applied on the nails and then dried with an UV lamp. While no specific pregnancy-related risks have been observed due to its application, there has been a report on increased risk of skin cancer due to the UV exposure. In addition, the removal needs acetone for 20 minutes (see gel nails). Therefore, you best avoid it.

  • An issue to consider with these more “permanent” techniques is that, in case of an emergency or hospitalisation, where we may need to check the oxygen level from your thumb, permanent nail polishes will not allow us to do so, as hospitals usually do not have the means to remove it!
  • Some studies have shown an increased risk of miscarriages in salon workers. Therefore, if possible, you could ask a colleague to take over some of your work while you’re pregnant. If inevitable, take the following precautions:

•wear a face mask and rubber gloves

•work near a window

•take regular breaks for fresh air

8. Skin care and cosmetics

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In general you can keep using your usual make-up and skin care regime as there’s no evidence that any cosmetics will be of any harm to your baby, with the exception of some anti-ageing creams (see below).

Cosmetics are covered by very strict safety laws, so you can be quite reassured that your moisturiser, serum, foundation or lipstick are safe to use when pregnant.

Acne medication and anti-ageing creams are related because they can both contain retinoids (a type of vitamin A). Retinoids are known to cause birth defects when taking orally. The main concern is the acne drug isotretinoin, which can be extremely harmful for the baby if taken during pregnancy. Retinoids are also used in some anti-ageing creams as they can speed up skin’s renewal, so stay away from them.

9. Spa visits

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You can indulge yourself at a spa, get a massage, make a facial, get a manicure or pedicure. There are certain things, though, that you should avoid while visiting a spa:

  • saunas
  • steam rooms
  • tanning beds
  • hot springs
  • whirlpools, hot tubs and spa baths

All the above mentioned pose a risk of overheating, dehydration and fainting; there is a slight possibility that excessive heat may affect your baby’s development. If you are exercising in water, the temperature of the water should not exceed 32 0C, otherwise check that the water temperature is below 35 0C.

10. Sunscreens

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Sunscreens are perfectly safe for use in pregnancy. Some of them do not penetrate the skin and others get absorbed but in very low amounts. Sunscreens containing titanium dioxide and zinc oxide may be preferred as they are powerful physical sun blockers and do not penetrate the skin.

11. Teeth whitening

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Teeth whitening involves bleaching your teeth to make them lighter through a peroxide-based whitening agent or a laser. According to the British Dental Health Foundation, teeth whitening in pregnancy is best avoided as we are unaware of the potential side effects on babies.

MEDICATIONS

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Few medicines have been established as safe to use in pregnancy. Medications in general should be used as little as possible during pregnancy and should be limited to circumstances whether the benefit outweighs the risk.

It is very important that you mention to your doctor any medicine you may be taking or you take occasionally. Some medicines may harm your baby and will need to be replaced by safer ones, whereas others are indispensable for you and you should keep taking them.

As  a rule, do not take unnecessary medications during pregnancy, and this is particularly important during the first trimester, which is the period when the baby’s organs are formed.

Herbal Medicines

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“Natural” is not a synonym of “safe”, so do not assume that because something is natural or alternative is devoid of risk…

The only herbal medicines that have been assessed in trials and seem to be safe are ginger (used for nausea and vomiting in pregnancy) and red raspberry leaf (used to tone the uterus). The latter in several studies did not prove to be effective, but some experts propose, just in case, to use it only during the third trimester. You will find a list of herbal medications that seem to be safe and those that are better avoided here.

References
American Family Physician: Evidence-Based Prenatal Care: Part I. General Prenatal Care and Counseling Issues. April 2005, USA. http://www.aafp.org/afp/2005/0401/p1307.html
NICE: Antenatal Care- Routine Care for the Healthy Pregnant Woman. March 2008, UK
HAS: Comment mieux informer les femmes enceintes? Avril 2005, France
http://www.babycentre.co.uk/x536449/is-it-safe-to-use-essential-oils-while-im-pregnant
http://www.nhs.uk/chq/Pages/2402.aspx?CategoryID=54#close
http://www.babycentre.co.uk/a536346/herbal-remedies-in-pregnancy
Photo credits
Intro: Getty images; 1. Miran Rijavec, Flickr.com; 2. Getty images; 3. Wikimedia commons; 4. Getty images; 5. http://www.lingrid.lt/straipsniai/oda.png; 6. Pixabay.com; 7. http://glamradar.com/10-cute-and-easy-nail-designs-ideas/; 8. Joe Hsu, Flickr.com; 9. Casa Velas Hotel, Flickr.com; 10. Arne Hendriks, Flickr.com; 11. Getty images; Medications: Gatis Gributs, Flickr.com; Herbal: Pixabay.com