I didn’t have a chance to discuss this in my last website and even though I’m a week late I wanted to belatedly acknowledge the International Day of the Girl which was celebrated on October 11. In honor of that day, the CDC sent an email with information that they hoped would raise awareness about the health issues that impact young girls worldwide. They chose seven topics (none, thank goodness about Ebola) that should be addressed in order to promote the health and safety of girls. I thought I would outline them this week:

Binge Drinking
The CDC noted that “alcohol is the most commonly used and abused drug among youth in the United States.” According to their statistics one in five high school girls binge drink and half of high school girls who drink alcohol report binge drinking. That means that they’re consuming four or more drinks on a single occasion. This increases their risk of behavior problems, injuries, sexually transmitted infections, unintended pregnancy and also impacts their risk of becoming addicted to alcohol and future health problems.

Human Papilloma Virus (HPV)
This type of virus causes most cases of cervical cancer as well as vaginal and anal cancer. It’s now calculated that 14 million people including teens become infected with HPV every year! But here’s the good news… We now have an HPV vaccine that protects against the HPV types that most often cause anal, cervical, vaginal, vulvar and mouth/throat cancers in women. I’ve talked to most of my patients who are mothers, as well as my younger patients, about the importance of getting this vaccine and indeed have written several articles on my website. Here is a reminder: The HPV vaccine is recommended for girls and boys when they are 11 or 12 years old. It can lower HPV infection rate for teen girls by half. Unfortunately, only 57% of girls and 35% the boys have started the HPV vaccine series. We have to do better…

Indoor Tanning
As I hope we all know, this significantly increases skin cancer risk. The risk is highest among those who start tanning at a younger age. Nearly 33% of white high school girls have tanned indoors and some start doing this as early as age 14 or younger. Indoor tanning causes melanoma which is the deadliest type of cancer. It also contributes to premature aging. We do have laws that prevent young teens from using indoor tanning salons in California but I’m not sure that they are well followed. Somehow we have to promote the slogan that untanned skin is beautiful (and will stay beautiful longer). So many of us wish we had known this years ago.

Sexually Transmitted Infections (STI’s)
Teens and young adults between the ages of 15 and 24 account for half of all new STI’s. Clearly this is where choice of partner and condoms come into play or should I say foreplay…

Sexual Violence
The CDC reports that studies indicate that 36% to 62% of reported sexual assaults are committed against girls age 15 and younger around the world. In the United States, 40.4% of female rape victims where first raped before age 18.

Suicide
Among 15 to 24-year-olds, suicide accounts for 11% of all deaths annually!

Teen Pregnancy
In 2012, more than 86,000 teens in The United States ages 15 to 17 gave birth. As the CDC points out, this increases their medical risks and results in huge emotional, social and financial costs to the mother and her children. Becoming a teen mom affects whether the mother finishes high school, goes to college, and the type of job she will get.

I listed these alarming stats because I (and the CDC) think we should be aware of the major issues that impact the teen girls in our lives. Ignoring them will not help us address their problems. Yes, we should be celebrating the day of the young girl, but to do so, we need to make sure she stays safe and healthy.

This has been a fabulous week for me. On Monday, I was honored by the National Breast Cancer Coalition event titled “Les Girls”. Unlike most “disease dinners” this was a cabaret style stage show with television actors singing, dancing and providing fabulous entertainment to a few hundred guests who were there to raise money and awareness for this amazing organization. What made the evening so touching and rewarding for me was the fact that family, friends and patients came…

Now on to a new medical article… The Obstetrics and Gynecology Journal published an article this month on titled “Exposure to selective serotonin reuptake inhibitor’s (antidepressants) in early pregnancy and the risk of miscarriage.” This is very relevant because up to 15% of all women are affected with depressive symptoms during pregnancy. Untreated depression has been associated with preeclampsia, preterm delivery, low birth weight, and miscarriage. The question the researchers posed and sought to answer is whether SSRIs increase miscarriage rates.

In Denmark, where the study was carried out, the number of women being treated with an SSRI during pregnancy has apparently increased 16 fold from 1997 to 2010. In the United States, up to 13% of pregnant women are treated with an SSRI in the first trimester of pregnancy. Denmark, like the other Scandinavian countries, maintains amazingly detailed medical records on their entire population and these of course include statistics on pregnancy, miscarriage, procedures and prescriptions. The researchers identified 1,279,840 registered pregnancies between 1997 and 2010. Of these 71.2% ended up in live births, 17.7% in induced abortions and 11.1% in miscarriages. They also found that 1.8% of women were exposed to an SSRI during the first 35 days of pregnancy. Women exposed to an SSRI were more likely to be older, have a lower educational length, lower income and experienced more previous miscarriages compared with unexposed women. The statisticians calculated that the hazard rate of having a miscarriage in pregnancies exposed to an SSRI compared to those of unexposed women was 1.27. That means that those exposed had a 27% increase risk of miscarriage. But they also identified 1.8% of women who discontinued SSRI treatment 3 to 12 months before conception and of whom 13.8% experienced a miscarriage prepared with the 11.1% among the unexposed women. So their hazard rate for miscarriage after discontinuing treatment before conception was 1.24. In other, more understandable words, they had the same risk of miscarriage as women who continued taking SSRIs

Bottom line: It’s not the SSRI that increases risk of miscarriage but probably lifestyle factors associated with depression such as alcohol use, smoking or poor compliance for folic acid supplementation during pregnancy. Because the risk of miscarriage is elevated in both women who take an SSRI and those who stopped a few months before getting pregnant, there’s likely no benefit discontinuing the medication that helps alleviate symptoms of depression.

Up to 20% of women experience at least one episode of clinical depression in their lifetime. Talking to my patients and surveying my family, I sometimes think it might be even more than that… But I will cheerfully tell you about an article that came out in the New England Journal of Medicine on June 19. (The day before my birthday, a somewhat depressing event although I kept telling myself that aging is a privilege.) The article was titled “Antidepressants on Pregnancy and Risk of Cardiac Defects”.

According to the authors from the Department of Medicine at the Brigham and Women’s Hospital and Harvard Medical School, clinical depression occurs in 10 to 15% of pregnant women. The use of antidepressant medications during pregnancy has increased and is now reported to be 8 to13% in United States.. The chief concern is use of these meds in the first trimester pregnancy when potential teratogenic effects are more likely to occur, especially cardiac malformations. There been many studies that tried to address this issue and indeed on the basis of early results of two epidemiological studies, the FDA warned physicians that early prenatal exposure to Paxil could increase the risk of congenital cardiac malformations. Since then, however, other studies have been done with conflicting results and there is still significant controversy regarding whether this is (as the authors put it) “a serious concern or much ado about little.”

The current study published last week used a large national database of women from 46 U.S. states and Washington D.C. who were insured through Medicaid and were pregnant and delivered during the period between 2000 and 2007. Apparently this included close to 950,000 pregnancies. (Just so you know, Medicaid covers the medical expenses for more than 40% of births in the United States!). During the first trimester, 64,389 women or 6.8% used an antidepressant. The most common were Zoloft, Paxil and Proxac. When the researchers restricted their study to women with a recorded diagnosis of depression, they found that there was no increase in the risk of cardiac malformations among infants born to women who took the antidepressants during the first trimester as compared with infants whose depressed mothers did not. Other studies had not done this, they simply compared women who took antidepressants in pregnancy to those who most likely were not depressed and didn’t need them. The authors pointed out that in restricting the study to women with a recorded diagnosis of depression they have corrected for the potential influence on pregnancy of underlying psychiatric illness and associated conditions and behaviors which could increase the risk of malformations. These include smoking, alcohol and illicit drug use, poor maternal diet, obesity, diabetes and hypertension all of which are more common in women with depression than in those without. They also pointed out that women with depression and anxiety are more likely to use health care resources and hence there’s a higher chance of detecting a cardiac malformation in an infant who has a minor malformation that might otherwise have remained undetected and even self-corrected in early childhood.

Their conclusion: the use of antidepressants during the first trimester does not substantially increase the risk of cardiac malformations. They then add the phrase that is applied to just about every medication used in pregnancy. “In making decisions about whether to continue or discontinue treatment during pregnancy, clinicians and women must balance the potential risks of treatment with the risk of not treating”… In this case severe depression.

Although many of my readers are not pregnant, they may have used antidepressants in past pregnancies and worry about potential consequences an/or they have friends and family who will need to consider using antidepressants in current or future pregnancies. This study gives reassurance.

The May issue of The Journal of Obstetrics and Gynecology features a section called Current Commentary and this month deals with fetal imaging. The article included an executive summary on ultrasound by experts from multiple medical societies including the American College of Obstetricians and Gynecologists and the American College of Radiology. It addressed the indications for pregnancy ultrasounds, when to do them, how often and whether they are safe.

The introduction states that “Since the advent of fetal ultrasonography in the 1960s (that’s when I learned how to do it) the average number of obstetric ultrasonographies per pregnancy has gradually increased.” Indeed, ultrasound has been offered in shopping malls and in independent non-medical offices to look at the baby in utero…with 3D and 4D images and a take-home video. In the developing world, where there may be a premium on male babies, local ultrasound “clinics” offer early assessment of gender. (I personally saw this throughout rural and urban India). Gender selection with termination of a pregnancy after diagnosis with ultrasound has been horrifically abused during the “one child only” laws in China.

Although diagnostic ultrasonography is generally regarded as safe it is however a form of energy with effects on tissues. The acoustic energy of ultrasound can heat tissue and there is a risk resulting from a rise in temperature. In the fetus, cancer vulnerability is of particular concern in early pregnancy. Hence the experts recommend that ultrasound be used only when clinically indicated, for the shortest amount of time, and with the lowest level of acoustical energy compatible with an accurate diagnosis.( A lets-play-it-safe recommendation if I ever heard one!)

So what are the reasons for first trimester ultrasound? It is most frequently used to date the pregnancy. Dating by first day of a woman’s last menstrual period is less accurate than early ultrasonography dating because of cycle variability, variable time from the beginning of menstruation to implantation, as well as reliance on a woman’s recall. (This is not a sexist statement…just a fact that many women, especially those who are not trying to get pregnant don’t keep track.) Apparently between 11 and 42% of gestational age estimations based on menstrual dating are wrong! Gestational age accuracy is critical for many reasons including testing for malformations, diagnosis of small for dates gestations, large for dates gestations (a sign of diabetes and possible delivery problems), post term pregnancies, and of course, knowledge as to when to expect to deliver the baby especially if there is going to be a C-section. The best time to date the pregnancy with ultrasound is in the first trimester. At most it can be off by five days. The experts state that if dating criteria to establish the due date are unsure then first trimester ultrasonography is recommended. (Although not stated in the report, I and most of my colleagues suggest that if a pregnant woman bleeds in the first trimester that it is also advisable to do the ultrasound to establish that there is a heartbeat and that the pregnancy is viable.) The American College of Obstetricians and Gynecologists also states that they approve of offering first trimester screening for abnormal chromosomal number (aneuploidy ) assessment at 11 weeks to 13 6/7 weeks of gestation. At that time certain characteristics such as a thickened area behind the neck can screen for the possibility of Down Syndrome or Trisomy 18.

The consensus recommendation is that all pregnant women have one ultrasound study preferably between 18 weeks and 20 weeks of gestation. The physicians in the workshop state that ultrasound at that time allows for pregnancy dating and is also optimal for evaluation of fetal anatomy, diagnosis of multiple gestation, problems with amniotic fluid, abnormal placement of the placenta and evaluation of the length of the cervix. (A short cervix can lead to premature delivery.)

The group also discussed ultrasound in specific subgroups and conditions. They were especially concerned with obese women. More than one third of women in the US are obese before they get pregnant with a body mass index greater than 30 kg/m and more than one half of pregnant women are either overweight or obese. They noted that obese women are at increased risk for poor maternal and fetal outcomes including fetal structural anomalies. Unfortunately ultrasound done abdominally at 18 weeks in an obese pregnant woman is technically more difficult than that for a normal weight woman. Maternal obesity has been found to be associated with at least a 20% lower detection of fetal anomalies when compared with women with normal body mass. They therefore suggested that in obese women transvaginal ultrasound be done between 12 and 16 weeks; this may allow better visualization of the fetal anatomy. Alternatively an ultrasound exam at 22 weeks (approximately two weeks later than the usual time for a non-obese pregnant women) may also improve visualization of fetal anatomy.

Then they discussed twin pregnancy which now comprises over 3% of all live births in the United States. Ultrasonography plays a key role in management of these high-risk pregnancies. It allows the diagnosis of separate or shared placentas (the latter can be a problem) and evaluation for selective growth restriction. In twin pregnancies ultrasound frequency should range between 2 to 4 weeks after 16 weeks of gestation, especially if the twins share a placenta.

Visual confirmation that the pregnancy looks good and is developing appropriately is reassuring to both the patient and her physician. But the accuracy of the ultrasound certainly depends on the training and acumen of the ultrasonographer as well as the quality of equipment. A facility and technician who specialize in prenatal ultrasonography is always preferable. I certainly would not suggest that any pregnant woman get an ultrasound at a mall just to have one more pretty picture of the “baby-in-waiting”. Photo booths are for people already born! Yes, there is now an expert committee reiterating the fact that obstetrical ultrasounds should be ordered by a medical practitioner and be medically warranted. I hope most of us knew that…

This is not just a story about pregnancy woes….it really has to do with the way the American court of opinion can influence the regulation of medication. Many of you will remember the medication Bendectin, which was prescribed years ago to help control gestational nausea and pregnancy. (I took it along with 25 percent of all pregnant women! )

Bendectin was voluntarily withdrawn from the US market by the manufacturer 30 years ago. Nausea and vomiting occurs in 80% of all pregnant women between 6 and12 weeks of gestation. Roughly 1/3 of women who have nausea and vomiting of pregnancy have symptoms that are so severe that the quality of their lives and their pregnancy suffers tremendously. And 1% of pregnant women progress to a condition called hyperemesis gravidrum. Their persistent vomiting causes them to lose more than 5% of their body weight, develop an electrolyte imbalance and severe dehydration. The condition requires hospitalization, IV fluids and significant medication to stop the vomiting.

Bendectin was a medication that combined doxalamine succinate (an antihistamine) and peridoxine hydrochloride (vitamin B6) in one tablet. Between the late 1960s into the 1970s the medical journals began publishing letters reporting an association between Benedictin use and birth defects. (Well actually, at that time a general increase in reports of birth defects appeared as researches published the data that hospitals and medical organizations were releasing as they paid more attention to and recorded birth defects.) Lawsuits claiming that this product was a teratogen causing birth defects first appeared in 1980. And by the time the product was withdrawn in 1983 there were more than 300 pending lawsuits. However, as pointed out in an article in the section ” Prospective” in this week’s New England Journal of Medicine, “Courtroom testimony claiming that Bendectin was a human teratogen was markedly devoid of evidence-based corroboration”. As a result of all these lawsuits, Merrill Dow, the company that made Bendectin, withdrew the product … not because of safety issues, but because of financial concerns. The company’s insurance premiums had risen to $10 million per year which was only 3 million less than their total income from Bendectin sales.

So was Bendectin really a teratogen? In 1979 the FDA issued a talk paper stating that studies in animals as well as several large epidemiologic studies had provided no adequate evidence linking Bendectin to an increase risk of birth defects. Another review of 13 epidemiological studies found no association between Bendectin and elevated risk of birth defects. Data maintained by the birth defect monitoring programs of the CDC found that during the period from 1985 to 1987, (which was after the product was withdrawn) the incidence of birth defects was the same as that seen during the peak time of Bendectin use. There was actually an increase in the number of hospitalizations in the United States for nausea and vomiting of pregnancy in those years. It rose from 7 per 1000 live births to 16 per 1000 live births during the period from 1981 to 1987. So to make a long story short, pregnant women suffered and were more likely to be hospitalized once they did not have access to this drug.

So here’s the good news… Recently, the FDA approved Diclegis. Aside from the fact that it’s very difficult to pronounce or spell, this is a product that has the same combination of doxylamine and pyridoxine that had been marketed as Bendectin. I’m not writing this website as an advertisement for the new drug; I’m simply intrigued by the fact that the story of Bendectin demonstrates how important it is to make clinical decisions on the basis of scientific evidence and not on lawsuits. The FDA’s approval of the “new Bendectin” was based on efficacy and safety data from randomized, placebo-controlled clinical trials and took into account extensive data showing that this product is not teratogenic. Attorney-instigated lawsuits and the fear that they generate for manufacturers, physicians and patients was, in this case, finally superseded.

There are appropriate avenues to assess drugs and then there are litigious-inspired negative headlines. As physicians and patients we should prefer the former.

Most of you know about amniocentesis and chorionic villus sampling (CVS…not the drugstore!). A quick review: Since the 1960s women over 35 were told that they had an increased risk of having a child with the extra chromosomal that caused Down’s syndrome and that once pregnant this could be detected with amniocentesis. (A procedure in which amniotic fluid is withdrawn with a long needle inserted through the abdominal wall into the uterus at around 16 week’s gestation. Cells from the fluid are then cultured for 10 to 14 days and stained so that the chromosomes can be counted.) CVS procedure was developed in the 80s. (Cells obtained from the edge of the placenta are identical to those of the fetus. They can be obtained with an instrument inserted through the cervix under ultrasound guidance as early as 10 week’s gestation.They are then immediately stained and their chromosomes are counted and analyzed and in most cases allow for an early diagnosis.)

Noninvasive prenatal testing was developed in the 1970s when the first ultrasounds produced two dimensional images of the fetus in the uterus. Initially ultrasound was used for measurements to determine gestational age and later to view anatomy. And as ultrasound developed, a maternal blood test of a protein called alpha-fetoprotein was found to be associated with open neural- tube defects (spina bifida) and other fetal abnormalities if high and if low, Down’s syndrome. As these noninvasive ultrasounds and blood tests became more less expensive, “blessed” and backed by the major medical organizations, they were offered to pregnant women of all ages. Meanwhile, back at the ultrasound, engineers and radiologists improved the imaging devices, went to real time and three dimensions. This allowed physicians and their patients to view fetal cardiac, neural and skeletal development. The perinatologists also found that ultrasound in early pregnancy allowed them to measure the thickness of the tissue at the nape of the neck (nuchal fold) which could then help foretell fetal chromosomal abnormalities. This was added to the armamentarium of noninvasive prenatal testing.

This long introduction to prenatal diagnosis is my way of getting to an article in the New England Journal of Medicine that appeared in the February 27 issue. It basically is a “We have come a long way baby” introduction to a new noninvasive test using maternal blood to access fetal chromosomes. The actual fetal DNA is analyzed from small fragments of cell-freeDNA (cfDNA) that are shed from the placenta into the maternal circulation. The amount of fetal cfDNA in maternal blood increases rapidly at the onset of embryo development so that it represents about 10% of free DNA in maternal blood during the first and second trimesters. Currently a method called massive parallel sequencing (or if you care to know, next generation sequencing) which reads millions of sequences along the length of each chromosome can be used to determine abnormal fetal chromosome number (termed aneuploidy) in maternal blood.

The current study was carried out at 21 centers in the United States. Blood was collected from women with single pregnancies who were undergoing the standard screening of blood biochemical methods (which included a few more than outlined above) with or without ultrasound measurement of the nuchal fold in the fetus. The researchers compared rates of detection of certain extra chromosomes (that is three instead of two) in trisomy 21 or Down syndrome and trisomy 18 between the fetal cfDNA test and traditional tests. They then examined birth outcomes or chromosomal counts on terminated pregnancies. The series included 1914 women. Fetal cfDNA testing detected all cases of aneuploidy and the false positive rate was significantly lower than detection with standard screening.

A separate editorial in the journal predicts that a negative result in this type of maternal blood screening will help prevent the need for invasive testing. They also state that a positive test is not enough for a final prediction that the pregnancy is abnormal. Women who have a positive fetal cfDNA test will need amniocentesis or CVS to ascertain if the fetus has a triple chromosome 18 or 21. But once this test becomes less expensive, is studied in a larger group of “low risk” women and goes mainstream, the majority of pregnant women may be assured with just this blood test that, if negative, they will not have to undergo further invasive testing.

I know this was a long (and for many uninteresting) analysis of advances in prenatal testing. But for those obstetricians who spent most of their careers helping women ensure the chromosomal health of their pregnancies, and for their future patients, this is an exciting advance.

I have obsessively discussed the positive health aspects of the various forms of contraception in my newsletters over the past few years. (Clearly a part of my Planned Parenthood background!) I have also proclaimed gender health success when the Affordable Care Act (ACA) stated that after August 1, 2012, preventive health services recommended by the Institute of Medicine and endorsed by the Department of Health and Human Services would be covered by insurance companies. These services are meant to promote the development of a health system that sustains health rather than merely treats illness. The services include all FDA approved forms of contraception, the morning after pill as well as sterilization procedures. And women will now be afforded health mandated services for cervical cancer screening, screening for sexually transmitted infections, mammograms and maternity care. But as we all know, some religious organizations and private employers have demanded exemptions from providing contraception stating that this violates their religious beliefs. Many of us have been outraged. Our umbrage was beautifully voiced in a “viewpoint” article published in the May 15th Journal of JAMA. Three physicians from the Northwestern University Feinberg School of Medicine in Chicago, Illinois contributed to the article and I would like to share their arguments with you.

Like many gynecologists, I no longer deliver babies. (I do miss it, although I don’t miss the hours.) And I realize that most of my patients are not going to have to deal with decisions about delivery. But their friends, daughters, daughters-in-laws and even granddaughters may. There was a prominent article that came out in the May 8 issue of JAMA about elective cesarean delivery on maternal request (CDMR) and I thought that if this topic was important enough to warrant publication in this journal, it was worth bringing to your attention.

The prevalence of CDMR in the United States is not precisely known. In order to gather statistics about it, there has to be a diagnostic code which is used as an official indication for the procedure in order to record it as well as to bill insurance; unfortunately there is none. The author of the article stated that the prevalence of CDMR is probably less than 3% of all deliveries.. But what I felt was fascinating was that 18% of obstetricians responding to a 2006 survey from the American College of Obstetricians and Gynecologists indicated that they would prefer CDMR if they or their spouses were delivering an uncomplicated cephalic (headfirst) singleton (one baby) pregnancy at term. There was similar data from Britain that describe preference for CDMR in 10% of midwives, 21% of obstetricians, 50% of urogynecologists, and 50% of colorectal surgeons. The reasons that were cited included fear of labor, prior poor experiences with labor, concern about specific outcomes including anal and urinary incontinence, fetal injury, and need for emergency cesarean or operative vaginal delivery.

There can be complications for both methods of delivery…who said having a baby was easy or uncomplicated. After all, I and all other Ob-Gyns spent years training to help women do so. One source of concern is late term pregnancies, i..e. not going into labor at 40 weeks gestation. Data from an examination of California birth certificate recorded that 1284 stillbirths occurred among 1,653,809 pregnancies delivered between 39 and 42 weeks of gestation or 0.07764%. This suggests that 1288 CDMRs at or just before term might have prevented one stillbirth in this group.

Difficult vaginal deliveries can, as we all know, result in birth trauma, lack of oxygen to the infant’s brain and infection. But with modern obstetrics and monitoring, this has become increasingly rare. There may be a slight increase in bladder and rectal prolapse after vaginal delivery. But when it comes to urinary incontinence, a trial from Baltimore showed that although there were initial increased rates for urinary incontinence with planned vaginal delivery vs planned cesareans delivery (7.3% versus 4.5%), there were no differences between those who planned cesarean delivery and those who planned vaginal delivery when patients were questioned about symptoms two years after delivery.

On the negative side for CDMR, cesarean delivery without labor is associated with an increased risk of newborn’s respiratory complications and overly rapid heartbeat. If this occurs, the infant may have to be transferred to the NICU. The differences in respiratory outcomes between vaginal delivery and CDMR may actually be due to gestational age of birth. Often a planned cesarean section is scheduled before 39 weeks in order to make sure that the date is set and that labor doesn’t ensue before the elective schedule. There is a reason that the term “term” is so important. Prior to 39 or 40 weeks gestation, the infant’s lungs may not be completely mature. That means that although a women may want to “get it over” or choose a date that is convenient for her and her doctor’s schedules… She could delivery a premature infant (from the perspective of its lungs) and this should never be electively done before 39 weeks of gestation.

There is also a concern that cesarean section can result in a decreased chance for bonding between mother and infant especially if the baby ends up in the NICU. Studies have shown that, in general, after elective cesarean section there is less likelihood that there will be immediate breast feeding as well as decreased duration of breast feeding.

Finally, there is a concern about complications for future pregnancies in women who initially have CDMR. Results from a large NIH funded observational study show that the risks of placenta accreta (growth and invasion of placental cells into the underlying uterine wall that prevents the usual separation and delivery of the placenta) and gravid hysterectomy (hysterectomy performed at the time of delivery or in the immediate post partum stage when the uterus is still large and receiving much greater blood supply than the nonpregnant uterus) along with maternal blood loss and surgical complications, increase with increasing number of cesarean sections. Complication rates rise from 0.2% to 2.1% for placenta accreta and 0.7% to 2.4% for gravid hysterectomy in a first compared with a fourth cesarean delivery.

The current recommendations from the National Institutes of Health and the American Congress of Obstetricians and Gynecologists for planning Cesarean Delivery on Maternal Request (CDMR) are:
1. CDMR should not be planned before a gestational age of 39 weeks has been accurately determined.
2. CDMR should not be motivated by the availability of effective pain medication and management.
3. CDMR is not recommended for women desiring several children given the risks of placenta previa, placenta accreta, and gravid hysterectomy that accumulate with each cesarean delivery.

As I leave for a brief vacation over the holiday, I wonder (as do most Americans) what’s going to happen to that impending fiscal cliff. Somehow, I reassure myself our divided congress will get this settled. But I am less complacent about the outcome for healthcare in the year and years to come. Just before I got on a plane, I glanced at the New England Journal of Medicine (my reading choices are not as literate as they should be) and came across a special report titled: “Implications of the 2012 Election for Health Care- The Voters’ Perspective.”  So as we go into the new year, I thought it might be appropriate to share the results of this report with you…

Obama won! (Excuse the exclamation point.) We also now know how those who voted for him felt about health care. Here are the stats: Obama voters were three times as likely to say that healthcare was the most important problems facing the country as those who voted for Romney. Obama voters want the Affordable Care Act  (ACA, also known as Obama care) implemented and not repealed. Obama voters want a more activist federal government intervening in the US healthcare system over the next four years. Seventy eight percent of Obama voters favor implementing or expanding the ACA and having the federal government continue its efforts to ensure that most Americans have health insurance coverage. And 85% of Obama voters support having the government try to fix the healthcare system, including 55% who believe that the federal government should have more responsibility than state governments for fixing it. And, (just a few more statistics) the majority of Obama voters upholds changing the structures of the current Medicare program ( 83%) and Medicaid program (78%). Finally 8 in 10 Obama voters believe abortion should be legal in all or most cases.

Yes, we live in a democracy but that doesn’t mean that what the majority of voters favor will, indeed, be accomplished. Thirty of the nation’s 50 states will have Republican governors in 2013, many of whom may not consider the establishment of state health insurance exchanges and Medicaid expansion as their state’s mandate. It’s clear that this may become a contentious year for many reasons and healthcare may lead the “it’s not for us” list.

Meanwhile, back to the personal, each of us should do what we can to ensure our individual health. And I will try to continue to help you do this with timely information about prevention, diagnosis and health care innovations in the year to come.

I and my staff wish you a happy and healthy New Year!

I’m sure anyone who has read a newspaper in the past few months is aware of the fears that are engulfing (of should I say filling) the French women who have received silicone implants. A company in France produced a popular (and apparently not too expensive) implant termed the Poly Implant Prothese (otherwise known as PIP). It was sold in 65 countries throughout the world over the last decade and used for breast augmentation or reconstruction in more than 300,000 women. The company that made the implants was shut down by the French government for fraud in 2010. It turns out that they had been using industrial grade silicone that was (obviously) not approved for medical use. The concern was (aside from the fact that no woman wants her breasts augmented with the same stuff they use in building or road construction) that these implants were far more likely to rupture…. apparently of the 30,000 French women who have had these implants, 1,000 experienced a rupture or leak. The French are advising those women who still have PIP implants to have them removed. Other countries are deciding what to suggest and many are simply suggesting that the women discuss “what to do” with their physician.

Why has this not been a problem here in the USA? This timely question was addressed in an article in the January 14th issue of Lancet titled “Silicone breast implants: lessons from the USA.”

The silicon-gel implants that are used in our country have been FDA approved after a long and arduous history. Currently the FDA assures us that they are safe. Their approval has allowed 150,000 American women to get silicone-gel implants for breast augmentation and 46,000 women to get them for breast reconstruction in the last year alone. In 2010 after 2 days of public testimony from silicon implant manufacturers, surgeons and scientists, the FDA concluded that American women can “consent with confidence to procedures involving silicon implants, which are considered safe but with acceptable risk of local complications (rupture, tissue hardening, pain, inflammation, and infection).” (Note the same complications occur with non-silicone, i.e. saline implants.) And just to be more precise the FDA published a 63 page report assuring the safety of silicon-gel implants.

There is quite a chronicle that preceded this. Silicon-gel implants were available in the US since the early 1960’s, but not until 1976 were they regulated by the FDA. In 1988, the FDA classified them as devices (duh) that needed their safety and efficacy to be proven in order to stay on the market. They gave the manufacturers 30 months to provide the necessary data. Apparently they could not. In 1991, it was deemed that the data did not fully assess the risks and in 1992 (this s a history lesson!) the FDA imposed a moratorium on silicon-gel implants. They were only to be used for reconstruction (after mastectomy for breast cancer or redoes of bad previous implants) and not electively for augmentation until their safety was proven. Then all hell broke loose (at least litigiously) and in 1995 the biggest US class action lawsuit took place, for $4.3 billion. Subsequently, publications in peer-reviewed journals and a 400-page report of the Institute of Medicine failed to link systemic disease with silicon breast implants. The ban was lifted in 2006 and since then 2 manufacturers; Mentor and Allergan have supplied the US market. They have promised to conduct ongoing post-approval studies and are following 40,00 women for 10 years,

So right now we feel (sorry about the use of this word) that our silicon-gel implants are safe. The authors conclude with the statement that “some critics argue that the FDA’s approval process is too slow and bureaucratic” But they add “but at what cost to safety?”

I agree with them. We should expect no less.

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