Surgery is not for two
For women wanting to get pregnant, the soundest medical information is vitally important for their health and safety, and that of their babies. The riskiest thing a woman of childbearing age can do is to trust any medical information from reporters or a news story. No credible medical professionals would ever consider basing patient care decisions on news stories, either. Doctors know that the results could be devastating for the women and babies in their care.
Over recent years, fat women have been encouraged to have bariatric surgeries, with promises that it will help them get pregnant. Now, they’re hearing that bariatric surgery can help them have healthier babies.
The New York Times reported that a new study had shown that women who become pregnant after bariatric surgery have easier pregnancies with fewer complications and “their babies are also healthier and may be less likely to be born prematurely or to be very small.” This news story was taken verbatim from November 18th press releases issued simultaneously from the journal, the study’s sponsor and the academic center contracted to conduct the study. Not only did the journal study find no credible support for these claims, but the actual data it reported bore little resemblance to the news or its own Abstract. By glancing at the news or the Abstract, both women and their doctors could come away with misunderstandings that could put mothers and babies at risk. The news also failed to report the larger paper addressing pregnancy after bariatric surgeries also published last week. It suggested the risks to both mother and babies after bariatric surgery may be greater than realized. The study in the press releases and reported by the New York Times was published in the Journal of the American Medical Association. It was led by Dr. Melinda A. Maggard, M.D., at the University of California Los Angeles and colleagues with the Southern California Evidence-based Practice Center–RAND Corporation in Santa Monica. No news reporter appears to have actually read the review and all failed to correctly depict the studies. Only 27 studies were described in the review, with 19 papers repeated two to three times, for each factor examined. Most disconcerting, not one of the studies was reported as a randomized clinical trial. They were all observation studies and even then, none were prospective (looking forward and following all of the women). The only studies included in this review were case studies or small (7-79 patients) retrospective cohort studies, many without controls and others with selectively matched controls, reporting correlations. Retrospective studies don't allow us to evaluate risks because they only give glimpses of those who survived the surgery and were healthy enough to get pregnant. The studies universally suffered from weak methodology, the most problematic being selection bias (no randomization of the study populations, largely anecdotal and case reports, and selective control groups used for comparisons), copious missing data and small sample sizes. Five of the 27 studies in the review were survey questionnaires, and one was nothing more than 17 anecdotal reports from a bariatric newsletter. One [Richards et al. 1987] had reported on only 162 of the responses from a survey of 580 bariatric patients done from 1979-1983; another [Marceau et al. 2004 ] had mailed out 918 questionnaires and of the 85% returned, 109 pregnancies were described; another [Tietelman et al. 2006] received only 51% of their mailed questionnaires back. In other words, these are not the types of studies that a clinician would use as evidence for the effectiveness and safety of a medical intervention. Nor is this the type of evidence that the FDA would accept as proof of the effectiveness or safety of a drug or medical device before permitting it to be marketed to the public. The media has no such requirements in reporting health news. The poor quality of the studies found by these reviewers made any conclusions impossible and any claims unsupportable. Maternal deaths weren’t reported at all. Cesarean deliveries were inconsistent, with some reporting more, less, or no difference after bariatric surgeries, or C-sections were not reported at all. Every woman is concerned about having a healthy baby, but almost none of the studies even reported neonatal outcomes: the number of low-birthweight babies, perinatal deaths and premature deliveries. Five of the six that did at least report premature deliveries found slightly more preemies after bariatric surgery than among controls. There should at least be some evidence, after more than 40 years of these elective surgeries being performed, before they are marketed as offering a new benefit. Few doctors would publicize a risky surgical intervention for young women as being safe and effective for healthier pregnancies, with no clinical data at all — especially when best estimates have found bariatric surgeries increase overall mortality risks for patients 7-fold in the first year and by 363% to 250% the first four years post-op. But, in the review’s Abstract, general lack of evidence was used as evidence: “Neonatal outcomes were similar or better after surgery compared with obese women without laparoscopic adjustable gastric band surgery,” the Abstract stated. What wasn’t made clear in the Abstract was that this claim was supported by citing the results of a single observation study of 13 bariatric patient deliveries and ignoring the missing data in the second study. “No differences in neonatal outcomes were found after gastric bypass compared with nonobese controls,” the Abstract reported. But, most of the studies in the review had missing data and hadn’t reported neonatal outcomes, and all three of the gastric bypass studies that had reported premature deliveries had found 17% to 71% more preemies born to the surgery patients than controls. This is an example of why it is so important to critically examine the actual data revealed in a published study, because it can present a very different picture from the interpretations and claims in the news: The media hasn’t revealed that the review had only been able to find six papers that even addressed fertility outcomes among women after bariatric surgery, and two were survey questionnaires with low response rates, offering only anecdotal reports. The largest observational case series in the review was of 298 consecutive deliveries after bariatric surgery — which found that three times more bariatric patients had required fertility treatments to become pregnant compared to controls (6.7% versus 2.3%). Another small case report that compared pregnancies among women with gestational diabetes reported that the women who’d had bariatric surgery were 4 times as likely to have required fertility treatments to become pregnant compared to controls (21.4% versus 5.5%). Among the two questionnaires returned reporting pregnancies, one found no difference in fertility treatments and one said that 15 out of 32 women said they were able to get pregnant after bariatric surgery. Hardly evidence that bariatrics increased their fertility. The only two papers reporting improved fertility were 15- to 20-year old case reports on a total of 21 selected women who’d had vertical-banded gastroplasty (a procedure known as stomach stapling and rarely done today), and with sample sizes too small to have statistical power. The review stated: “Most observations on fertility following bariatric surgery lack complete data on the total number of women attempting to get pregnant and pregnancy rate. Most studies present convenience samples of women who were able to get pregnant, in whom presurgery fertility histories were available.” The review found no clinical outcome data to support claims that bariatric surgeries improve a woman’s chances of having a baby. While the news media and press releases quoted Dr. Maggard as saying they recommend waiting about one year, that is not what the review’s data revealed, nor is it the consensus of the medical community. Available research examining how soon after bariatric surgery women should become pregnant is limited, the review stated, and comes mostly from case reports or small cohort studies. The vast majority of studies the review identified had reported higher risks with pregnancies that occurred within the first two years of surgery, regardless of the procedure. In studies of laparoscopic adjustable gastric banding (LAGB), biliopancreatic diversion/duodenal switch (BPD), and Roux-en-Y gastric bypass, the review found reports of: ● 31% spontaneous abortions following BPD compared to 18% in matched controls ● 29% spontaneous abortions following lap bands (no control group) ● more premature deliveries after bypass procedures — 50% among pregnancies within the first 12 months post-op; in 25% of pregnancies from 13-24 months post-op, and 20% for pregnancies 2 years or later after surgery. ● 18% premature deliveries within first 2 years after gastric bypass in another case study Of twenty published reports of surgical complications during pregnancy after bariatric surgery, 25% of the babies died and 15% of the mothers died. The most common (70%) complications in the literature were bowel obstructions and internal hernias, which are life-threatening. The August issue of the New England Journal of Medicine, for example, reported the tragic case of a pregnant woman who died after her intestines had herniated and become gangrenous. Her 31-week baby died, too. She had had bariatric surgery 18 months earlier. Most doctors recommend women not become pregnant for at least two years after surgery and after her weight stabilizes, said Dr. Sattar Hadi, who runs the high-risk obesity clinic at Vanderbilt University’s Center for Human Nutrition. Dr. Mark Tucker, director of bariatric surgery at the University of Medicine and Dentistry of New Jersey, also told the press that hernias similar to the one experienced by this mother are common up to five years following gastric bypass. Among the six studies of pregnancies after gastric bypass that were identified in this review: ● one reported 11.5% of the women had anemia that required parenteral (IV) iron, which was more than ten times the rate of pregnancy-related anemias found among control pregnancies; ● six cases of babies with neural tube defects were reported among women not taking supplements; ● another study reported 4.4% of women required IV iron for anemia. Among the six BPD studies: ● 21% of women required parenteral nutrition for severe nutritional problems, ● four out of nine women in a small study required transfusions or supplements and one also required parenteral nutrition; unrelated to supplementation adherence; ● another small study reported one in four women had anemia despite iron supplementation; ● two other studies reported 20% and 32% of women required full parenteral nutrition to address severe nutritional problems. The nutritional outcomes were only reported in one small LAGB study, which reported no nutritional events. But in four other studies of lap bands, according to the authors, nearly one in five women had required their bands removed or deflated because of severe vomiting and nausea. Given the importance of good prenatal nutrition for the growth and development of a healthy baby, it would be expected that any procedure that reduces a woman’s caloric intake to about 1,000 kcal/day, not to mention impedes the absorption of essential nutrients, would increase risks for nutrition-related complications. With the nutritional complications that have been extensively reported in the medical literature among general bariatric patients and among young people, it is not surprising that the American College of Obstetricians and Gynecologists has cautioned that women getting pregnant after bariatric surgery “may see a host of complications such as gastrointestinal bleeding, anemia, intrauterine growth restriction, prematurity and neural tube defects. The surgery can also lead to deficiencies in iron, vitamin B12, folate and calcium,” it stated in its 2005 Guidance to obstetricians and gynecologists. In the review’s concluding comments, the authors noted that “inherent limitations in the identified studies preclude us from drawing strong conclusions.” They called for randomized clinical trials or prospective cohort studies as needed to address this question. Yet, despite the lack of credible evidence in the review article to support the use of bariatric surgery for enabling women have healthier babies, the Abstract concluded: Rates of many adverse maternal and neonatal outcomes may be lower in women who become pregnant after having had bariatric surgery compared with rates in pregnant women who are obese; however, further data are needed from rigorously designed studies. This is one study where the sponsor and its role in the review may be valuable for both healthcare professionals and consumers to pay close attention to. Funding/Support: This project was funded under contract 290-02-0003 from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services to the Southern California Evidence Based Practice Center. Dr Maggard’s time was supported in part by a grant from the Robert Wood Johnson Physician Faculty Scholars program. Role of the Sponsor: The Agency for Healthcare Research and Quality had input into the general design and conduct of evidence reviews conducted by the Evidence Based Practice Centers, but not this evidence review in specific. The sponsors were not involved in the collection, management, or analyses of the data, but did review and provide comments on the evidence report upon which this article is based. The AHRQ established a network of twelve practice centers at universities and private organizations to produce reviews and technical reports, which opened the doors to increasing influence of stakeholder interests, especially surrounding preventive health, with Robert Wood Johnson Foundation funding numerous AHRQ initiatives.* There are now “close relationships” between these academic centers, federal health agencies and professional organizations, which regularly attend U.S. Preventive Services Task Force meetings and provide draft review documents, explained doctors Steven H. Woolf, M.D., MPH., and David Atkins, M.D., MPH, in their historical review of clinical guidelines. From then on, achieving consensus among the private-public stakeholders took on a greater importance. This JAMA review of bariatric surgeries and pregnancy outcomes reveals that the AHRQ influences the reviews and technical reports themselves. What all of this means, and the news hasn’t reported, is that this review paper in JAMA was an abbreviation of the larger Evidence Report/Technology Assessment titled Bariatric Surgery in Women of Reproductive Age: Special Concerns for Pregnancy that was published at the same time. It was written by the same authors at the UCLA practice center (the Southern California Evidence-base Practice Center-RAND Corporation), along with its invited Technical Expert Panel. This Evidence Report/Technology Assessment had also been contracted by the AHRQ to the author’s practice center. As it states: AHRQ encourages the EPCs [evidence-based practice centers] to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the nation. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers, as well as the health care system as a whole, by providing important information to help improve health care quality… The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services… This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. We’ll look at the disclosure statement at the end and who those partner organizations might be. But first, let’s closely read this technical assessment because it offers additional information that may help women. The most striking thing that stands out when one reads the actual Technical Assessment is how dramatically different the evidence is from the media statements and press releases issued by both the RAND Corporation and the UCLA practice center. As the RAND press release stated: Obese women who have weight loss surgery before becoming pregnant have a lower risk of pregnancy-related health problems and their children are less likely to be born with complications, according to a new RAND Corporation study. Women who underwent bariatric surgery and lost weight before becoming pregnant had a significantly lower risk of gestational diabetes and high blood pressure than obese women who did not have surgery, according to the study published in the Nov. 19 edition of the Journal of the American Medical Association. In addition, these women's babies were less likely to be born prematurely, be born underweight or be born overweight than children born to obese women, according to the study. "Obese women who undergo bariatric surgery and lose weight prior to becoming pregnant may improve their own health, as well as their children's health," said lead author Dr. Melinda A. Maggard, a UCLA surgeon and a researcher at RAND, a nonprofit research organization. "Further research is needed, but the results seen thus far are positive." In comparison... Our findings are based on observational studies, which have a potential for greater bias. Furthermore, many of the studies lacked the necessary design to allow for definite conclusions (i.e., patient selection not defined, no presurgery pregnancy information). Our overall findings are therefore tempered by the limitations in the available data, and are cautious. These moderated statements are considerably different from the press releases and the news headlines which assuredly reported that research had found bariatric surgery helps fat women have healthier babies. Similarly, medical professionals who read only the Abstract, rather than the full report or the original studies it referenced, might also come away with an impression that the evidence is stronger than it is. The Abstract had concluded: “The data suggest that fertility improves after bariatric surgical procedures, nutritional deficiencies for mother and child are minimal, and maternal and neonatal outcomes are acceptable with laparoscopic adjustable band and gastric bypass as long as adequate maternal nutrition and vitamin supplementation are maintained. There is no evidence that delivery complications are higher in post-surgery pregnancies.” It is doubtful that anyone reading the full 77-page report and appendix would reach those conclusions. Bariatric patients. In reading the technology assessment, what first jumps out is that bariatric surgeries are primarily done on women of childbearing age (18-45 years) and they represent the greatest growth in people having these procedures — yet young women are the demographic group with the lowest risks for premature death and morbidity, and the most “morbidly obese” women still have longer life expectancies than even normal-weight men. To attempt to learn how many bariatric surgeries were being performed in women of reproductive age, the authors analyzed data from AHRQ’s Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample for the years 1998-2005. These use ICD-9 procedure codes with diagnosis criteria from hospital billing claims. Since they don’t include outpatient procedures, they noted that outpatient laparoscopic band and bypass procedures wouldn’t be captured, so its figures will underestimate the actual number of bariatric procedures. Never the less, they found a dramatic increase in the number of procedures performed each year — about a 600 to 800 percent increase since 1998. In just the past three years, about 50,000 women of childbearing age have had inpatient bariatric surgery. But no one knows how many of them have gone on to become pregnant, the report stated. Of special note were the lengthy discussions of the nutritional effects of bariatric procedures. The authors found scarce published research examining the nutritional supplement needs, such as vitamins and iron, for women after bariatric surgeries, or their most effective forms. They were unable to make nutritional recommendations for pregnancy. Studies on bariatric procedures that result in degrees of malabsorption are more available and suggest more significant nutritional-related adverse events. BPD. BPD is associated with more severe nutritional deficiencies and adverse neonatal outcomes than any other type of bariatric procedure, the authors stated. Beyond those already described above, the review found that parenteral nutritional support had been required in 21% of post-BPD pregnant women, with about one-third of these women needing hospitalization. In another small case series, “all four patients tested suffered from nutritional deficiencies, requiring blood transfusions, parenteral nutrition, or parenteral iron supplementation.” Case reports were suggesting the risks may be greater than realized: In one case, dehydration and malnutrition as a result of vomiting and diarrhea led to an emergent caesarian section despite vitamin supplementation and multiple hospitalizations to administer intravenous fluids. Another case report demonstrated vitamin A deficiency in pregnancy following BPD; late in the pregnancy, the patient was hospitalized 5 days weekly for parenteral nutrition. The baby was still found to have symptoms of vitamin A deficiency, such as micropthalmia, at birth. As the risk of nutritional adverse events in pregnancy following BPD is appreciable, even with good compliance with supplementation, it is logical that there are [also] reports of adverse events following noncompliance with supplementation. For example, there is a case report demonstrating neonatal vitamin A deficiency with maternal night blindness during the third trimester associated with refusal of nutritional treatment during pregnancy following BPD. Gastric bypass. Among the limited data on gastric bypass patients, in addition to the reports already mentioned, this review discussed two case reports of failure to thrive in babies which was thought to be due to low-fat content in the mother’s milk, and another documented vitamin B12 deficiency in the babies. While most reports attempt to attribute problems to a woman’s noncompliance with supplements, this review found that wasn’t always the case: There are also case reports of maternal and neonatal nutritional deficiencies during pregnancy in patients following gastric bypass despite compliance with supplementation. One case study reported on neonatal B12 deficiency despite the use of prenatal vitamins during pregnancy and lactation. Another case report documented iron and vitamin B12 deficiencies starting at six weeks gestation; the patient required parenteral B12 and blood transfusion due to the anemia being refractory to parenteral iron… Among the case series studies on pregnancies after gastric bypass, they said that the most notable finding was the higher than expected number of babies with neural tube defects. “One report was about three women who had four pregnancies, all of which had neural tube defects, and the other report was a case series of 110 pregnancies in 87 women who had received gastric bypass; three babies had neural tube defects.” “An important caveat,” the authors highlighted, is that published reports of pregnant women after bariatric surgeries have not monitored the vitamin, mineral and trace element levels in mother or baby, “and if clinical manifestations of these deficiencies are subtle and thus difficult to detect, they may be higher than reported.” The rate of gestational diabetes in post surgery pregnancies could conceivably still be twice as high as community rates. Therefore it is premature to conclude that bariatric surgery reduces the rates of these complications to those of the average women. One stillbirth and one case of duodenal atresia occurred in pregnancies following bariatric surgery; sample sizes were too small to draw conclusions. The five case series articles included 141 pregnancies in total. They reached the same conclusion about studies suggesting that gastric bypass might reduce rates of gestational diabetes, preeclampsia and hypertension, finding the sample sizes too small to make any credible conclusions, regardless of the procedure. It’s important to note that they repeatedly caution that the data is insufficient and studies are too small to reach valid conclusions about purported benefits for reducing pregnancy-related complications. The reviewers also said that because of the limited data, it’s not known if pregnancy increases the risks for surgical complications associated with bariatric procedures. “We identified over a dozen reports of complications requiring surgical intervention during pregnancy following bariatric surgery, many with deleterious effects for the neonate and mother,” they said. The complications included bowel obstructions, hernias, mid-gut volvulus, band erosion and bleeding, perforated gastric ulcer and strictures. Most complications required surgery and “the maternal and fetal mortality and morbidity rates associated with these types of complications are high,” they stated. As they described: An emergent cesarean section or premature rupture of membranes occurred in six of 13 cases (46%). Overall five of 13 (38.5 percent) neonates died (one natal outcome was not reported). Five were delivered at full-term. There were three maternal deaths (21.4 %). Several patients were in florid septic shock by the time the problem was identified. They cautioned that any pregnant women presenting with gastrointestinal symptoms should be worked-up without delay for bariatric surgical complications. This review also stated: “We conclude there is scant evidence of pregnancy outcomes upon which to make recommendations about how long to delay pregnancy following surgery.” The review closed with an additional note calling for more research, saying: “Much more research is needed to answer almost every key question in this report.” The actual report provides a considerably different perspective of the evidence than consumers, public officials and healthcare professionals have heard from the media and press releases. Television newswire services are now broadcasting stories of “surgery for two.” Ivanhoe Broadcast News, which distributes medical news to more than 250 television networks, is telling women that bariatric surgery “may be the healthiest decision for both mother and baby.” © 2008 Sandy Szwarc According to the article published in JAMA: “Financial Disclosures: None reported.” Consumers and healthcare professionals were left to believe there were no potential sources of bias. Yet, the interpretations presented to media and in the press releases deviate so dramatically from the actual data, a closer look might help us understand. Lead author, Dr. Maggard founded and is the Deputy Director for the Center for Surgical Outcomes and Quality at UCLA and has an adjunct appointment at RAND, working on several projects with the UCLA practice center, commissioned by AHRQ. Remember the role of the AHRQ in contracting with practice centers to create data for clinical guidelines and quality (performance) measures. Co-authors Sydne Newberry, Margaret Maglione, Paul Shekelle and Lara Hilton are also affiliated with the RAND Corporation. Dr. Maggard led another meta-analysis in 2005, also authored by the UCLA practice center and RAND, reporting that bariatric surgery is more effective than nonsurgical methods for weight loss and comorbid conditions. These same authors also wrote the Clinical Guidelines on the Surgical Treatment of Obesity for the American College of Physicians, published in the April issue of Annals of Internal Medicine, based on that meta-analysis. Dr. Maggard is also a Robert Wood Johnson Clinical Scholar, a fellowship program which funds graduate degrees and research to foster physicians who will lead the transformation of public health and go on to have other leadership roles. RWJF has awarded her a $300,000 grant to develop multidisciplinary approaches to improve bariatric surgery outcomes. RWJF, as readers know, is the foundation of Johnson & Johnson, Inc., which has $53.324 billion in annual sales and is the world’s largest supplier for bariatric surgical devices and lap bands (Ethicon Endo-Surgery, Inc.). It’s also an international giant in weight loss and healthy eating products, selling nutritional supplements (McNeil Nutritionals, LLC), artificial sweeteners (Splenda), diet pills, and employer wellness programs (J&J Consumer Companies, Inc. Vida Nuestra). RWJF partly sponsored this review article. RWJF has sponsored numerous projects at RAND, such as convening an Expert Panel, in which five member were from RWJF, to make recommendations on the management of chronic diseases for the U.S. HHS Centers for Medicare and Medicaid, contracted from 1998 to 2003. Paul G. Shekelle, M.D., M.P.H., Ph.D., is not only the director of the UCLA practice center for the RAND Corporation, he is the co-chair of the Editorial Board for the National Guideline Clearinghouse/National Quality Measures Clearinghouse at the AHRQ. He is also the Associate Director of the Robert Wood Johnson Clinical Scholar Program at UCLA. Another author of this review, Dr. Heena P. Santry, M.D., is also a Robert Wood Johnson Clinical Scholar and has led other studies supported by RWJF, including one in the 2007 issue of Annals of Surgery called “Predictors of Patient Selection in Bariatric Surgery,” a 2005 study in JAMA on “Trends in Bariatric Surgical Procedures,” and another in a 2006 issue of Social Science & Medicine called “Internet marketing of bariatric surgery: Contemporary trends in the medicalization of obesity.” Another author of this review, John M. Morton, M.D., is a bariatric surgeon and a Robert Wood Johnson Clinical Scholar. He is the Director of Bariatric Surgery at Stanford Medical Center, was on the RAND Expert Panel on Bariatric Surgery, and on the Research Committee for the American Society of Bariatric Surgeons. He co-authored an article in the February special supplement on the rising epidemic of obesity in Diabetes Care titled “Bariatric Surgery in Patients With Morbid Obesity and Type 2 Diabetes.” According to RAND, he is also the President-elect of the California Chapter of the American Society of Bariatric and Metabolic Surgeons, and was Associate Editor of the ASBS journal Surgery for Obesity and Related Diseases, and on the Editorial Board for Obesity Surgery. Dr. Edward H Livingston, M.D., is a well known bariatric surgeon and wrote the book on Bariatric Surgery. Dr. Zhaoping Li , M.D., Ph.D., webpage at UCLA states she has conducted three industry-sponsored obesity studies. The point being, that seeing “no financial disclosures” at the end of a study does not mean that the authors have no career interests in an issue. Disclosure statements aren’t required to reveal funding or appointments that come through foundations or academic positions. “The Partnership for Prevention convened a panel to develop methods for prioritizing services,” explained Drs. Woolf and Atkins. The priorities it outlined provide the basis for future priority-setting among policy makers to improve the execution of preventive guidelines. These priorities were written with Robert Wood Johnson Foundation, Merck & Co., the AHRQ, Health Partners Research Foundation, American College of Preventive Medicine, CDC, and others. As readers may remember, Partnership for Prevention is a nonprofit dedicated to increasing the adoption of preventive health practices and public policies and legislation. The Partnership is funded by RWJF and GlaxoSmithKline. Its initiatives include promoting the government’s Healthy People goals and workplace wellness programs. Its member organizations include stakeholders in screenings and preventive health, from Abbott Laboratories to Wyeth Pharmaceuticals.
The Rand Corporation Review
This wasn’t actually a study providing new clinical research, but a thorough review of the literature. In this paper, the authors searched multiple electronic databases for articles published between 1985 and February 2008 to identify those about bariatric surgeries in women of childbearing age that also reported fertility, contraception use, and selected maternal and infant outcomes. They also searched the Nationwide Inpatient Sample (1998-2005) of ICD billing codes to calculate the total number of bariatric procedures done each year. The authors said that they identified 1,102 articles and went on to screen 260 before including 75 in this review.
Bariatric surgery improves fertility?
Perhaps the cruelest false hope and potentially most dangerous claim in the news has played on women’s desires to get pregnant and encouraged fat women who want to have a baby to have bariatric surgery to increase their fertility.
When is it safe to get pregnant after bariatric surgery?
Are nutritional complications the fault of the women or the surgeries? 
According to the New York Times reporter, the nutritional problems seen among some women “appeared to be caused by their failure to take recommended supplements of multivitamins and iron.” But that wasn’t what the study data showed. The reviewers only reported 13 case studies (two of which were surveys and one was merely a report of 36 women who’d volunteered from an advertisement) and of those studies, in more than half, the researchers had failed to even follow vitamin supplement adherence. As the review noted, few of the available studies had been designed to follow nutritional outcomes; instead, for example, they were looking at contraceptive use. Even so, the nutritional information that emerged from these studies lends a note of caution for women.
The sponsor 
As previously covered, the Agency for Healthcare Research and Quality (AHRQ) is the health services arm of the U.S. Department of Health and Human Services and its function is to support the government’s public health initiatives. As readers may remember, the role of the AHRQ was changed in 1998. It no longer just sponsors the development of clinical practice guidelines by independent professionals. This government agency was redirected by Congress to finance outside centers to conduct reviews of the evidence and compile technical reports. These reports are then used by stakeholders, such as third-party payers (employers, insurers and the federal government), to create guidelines for managed care. These also become the performance (“quality”) measures that providers must comply with in order to receive reimbursement. The AHRQ reports are also to be used by policy makers to shape public policies and for regulatory and public funding legislation. By its 2006 Congressional budget report, AHRQ said it had made “significant improvements in realigning the work we do with our strategic goals and those of the Department [of HHS].”
The Technology Assessment
The technology assessment followed the same methodology and reviewed the same body of evidence as in the paper published in JAMA, but it provided more detailed information on the 57 studies included in its review. In describing the studies its literature search found, the technology assessment was extremely reticent, stating: 
Lap band. According to the reviewers, no studies have examined pregnancy-related nutritional outcomes among lap band patients or described the vitamin supplementation regimens, although one observational study of 79 women reported no nutrition problems. The reviewers identified only three case series of pregnant women who had had gastric banding. In the two that had reported pregnancy outcomes, 72-78% of the women had carried their babies to term. And among all three studies, 18% of the women had had to have their bands removed or deflated for severe vomiting, dehydration and electrolyte abnormalities. Some women had difficulty complying with vitamin supplementation because of chronic vomiting. They also found a case report of a pregnant woman with a lap band who developed severe vomiting and weight loss that led to severe fetal growth retardation and the mother required enteral nutrition via a feeding tube to normalize the fetus’ weight gain. Overall, the reviewers said that the evidence was insufficient for them to reach conclusions and make recommendations on band management in pregnant patients.
Pregnancy complications. While two small studies had reported rates of gestational diabetes, preeclampsia and hypertension after gastric banding were reduced to rates similar to those in the community, the authors said the small sample sizes made it impossible to determine if these complications are actually still elevated after bariatric surgery. Examining absolute values they said:
“Surgery for two” may make a catchy news headline or sales pitch, but it does not make sound medical information women should use to make any healthcare decision. Please, ladies, keep safe and protect yourselves and your babies. Don’t make a life-altering or life-threatening decision based on anything you hear from media. Media is only entertainment and advertising.
Disclosures
* There is no evidence that government-funded healthcare will divest itself from political-commercial interests, given how the establishment of performance guidelines, especially preventive health guidelines, have been set up. As Drs. Woolf and Atkins explained, along with the changes in the AHRQ’s role in supporting the government’s health objectives, changes were put into place to strengthen the role of stakeholders and the compulsory nature of preventive health guidelines.
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