Author Archives: Srihari Yamanoor

Brief: WebMD publishes a very useful interview on the link between talcum powder use and cancer

It has been a busy couple of months for me, with several projects that have required juggling, so I have not been able to post anything on Women’s Health issues. However, given the most recent verdict against Johnson & Johnson on a case filed by a woman with Ovarian Cancer, resulted in Millions of Dollars being awarded to her.

Any time this happens, of course, it causes a stir, as it should. However, I am not going to spend time on this post talking about the merits of courts allowing companies like J&J and many of the drug companies try to get away by not fighting lawsuits as a class, etc. Those discussions are for my other blog, and will go on for a long time. Plus, in this case, we cannot prove a causal relationship between talcum powder use and cancer, yet.

So, I want to touch very briefly on three takeaways from the interview, and suggest you get the rest from the horse’s mouth:

  1. Correlation is not always a result of causation. We may never find lasting proof that talcum powder use causes cancer. This is an important thing to remember.
  2. There appears to be no medical benefit at all from using talcum powder.
  3. So, given the correlation and the lack of any benefit, it is best to stop using talcum powder! This is what the Doctor interviewed in the article suggests! Sound advice, it would appear!

Please read the rest here: http://www.medscape.com/viewarticle/884700?pa=Vor1qEPNxHeNOj5AKsX1Hl55HifEoXQauwdv%2BVDi5uqIdvEbMsfStGAJbHUGqkcC8SIvl8zjYv73GUyW5rsbWA%3D%3D

Image, Courtesy, Pexels: https://www.pexels.com/photo/rear-view-of-woman-with-arms-raised-at-beach-during-sunset-320007/

Endologix Study on AAA treatment for women shows promise

In the past, I have written about how studies on devices and drugs seem to lack focus on women, for several reasons. Reasons range from a poor understanding of the differences in male and female anatomy and physiology, poor access to healthcare, lack of awareness and efforts to enroll women, and lesser demands for evidence from journals, insurers and other healthcare stakeholders. I previously posted about Boston Scientific’s efforts to enroll more women, and now, here is another positive study from Endologix.

Enrolling women, or studying the effects of devices, procedures and therapies exclusively in women go further than improving medical knowledge, when successful, they can also make for sound business sense, regardless of the risks and expenditure.

AAA – Abdominal Aortic Aneurysms 

The aorta is the main artery that supplies blood to most of the body, and in the abdominal region, it splits into two arteries that supply blood to the pelvis and legs. Due to smoking, high blood pressure and/or other risk factors, the aorta can come under pressure and enlarge, and eventually burst, which can cause hemorrhage and death, if not operated on immediately. Aneurysm also presents with a lot of pain, and the risk of rupture when the aneurysm reaches a certain size, requires surgical correction and grafting/stenting.

 Open Vs. Minimally Invasive Repair

There are two ways an abdominal aortic aneurysm is surgically treated – open surgery and minimally invasive repair through a groin incision. Both surgeries have approximately the same effectiveness, but open surgeries can take a long time to recovery, while minimal surgeries requires numerous post-surgical visits to ensure no leaks or other morbidity is present. However, eligibility for surgery varies.

Learn more about Endovascular Aneurysm Repair (EVAR)from this brief video (note that Cook Medical provided a grant towards the video):

The Endologix Lucy Trial

Endologix, which has developed a stent for AAA treatment, enrolled 225 patients, 149 male and 76 female. They claim that, with their stent, termed the Ovation® Abdominal Stent Graft System, increased eligibility for women by 28%.

Besides claims that the device reduces mortality and is better suited for women, the study is also the first to study the effects of the device and surgery on women. Women are at a lower risk for AAA, but the outcomes are worse for women treated through EVAR or through open surgery. I found a study that confounded this outcome difference, however, the study was not specifically well designed to study gender differences. However, it is clear that anatomical differences remain, and thus drive the variability in outcomes, and this is potentially why the Endologix device claim makes sense.

The results Endologix has presented, are of course, initial results based on the 30-day follow up period common for EVAR, and observations over long term will yield more confidence in the device’s ability to treat women better.

However, as I mentioned earlier, it makes for good clinical sense and business sense to enroll more women in clinical trials, and the Lucy trial is one more step in the right direction!

References:

  1. The MASS Device Article: http://www.massdevice.com/endologix-touts-30-day-data-study-ovation-stent-graft-women/
  2. A Business Wire write-up by Endologix: http://www.businesswire.com/news/home/20170531006467/en/Endologix-Reports-Positive-Clinical-Data-Ovation-LUCY
  3. A large, open-access study on gender based outcomes: http://www.jvascsurg.org/article/S0741-5214(12)02188-X/fulltext
  4. A Mayo Clinic Overview of AAA: http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/home/ovc-20197858
  5. Society for Vascular Surgery on AAA Repair: https://vascular.org/patient-resources/vascular-treatments/endovascular-repair-abdominal-aortic-aneurysms#whyitsdone
  6. Image courtesy, Pexels: https://www.pexels.com/photo/woman-water-girl-lake-134670/

 

An ancient imaging system proves to be an amazing cure for infertility!

Towards the end of the work week, Medical News Today revealed a story that looks like a miracle and something out of science fiction simultaneously. Infertility is a huge problem, with expensive, whose treatments are temperamental to say the least, fraught with emotional travails for families and other complicating issues.

And now, a single study appears to upend the problems and probably offer a simple, cost effective solution that will beat infertility right out of the cliched ball park! It is probably imprudent to get so excited, but it is hardly resistible.

Old techniques have gotten a second look in the past. Some of these techniques were trial and error prone, and many times the underlying science has not been understood. Renal Denervation is one such technique. With a surprising and incredible purchase of Ardian by Medtronic, it caused a frenzy, only to be let down by a poorly designed clinical trials. I have seen similar comebacks on old studies that controlled the Over Active Bladder condition. Therefore, one should look at any revivals of old techniques with ample caution.

Interesting Coincidences

Dr. Ben Mol, a Professor at Australia who spearheaded the study into an age old imaging technique as a possible treatment, appears to have been conceived as a result of this imaging treatment and has a younger brother! It seems remarkable that he started research intot his technique even before being made aware of his own history and relationship with the technique. Please refer to the MNT link below for more on this.

The Technique – Hysterosalpingography (HSG)

The technique, whose name is a mouthful, simply refers to imaging of the hystero, the uterus and salpingo, the fallopian tube. It was first carried out exactly 100 years ago, in 2017, just a few years after X-rays came into existence.

The procedure itself is a dye test, performed under X-ray. Water or oil are used to flush the Fallopian tubes. It is the flushing that appears to have aided fertility. In view of this notion, Dr. Ben Mol and others led a study with 1119 women, that produced interesting results.

The Study

The study, titled H2Oil was held in Netherlands, and as mentioned before, recruiting 1119 women, approximately half received HSG with oil, and as MNT put it, Lipidoil Ultra-Fluid, an iodized solution of fatty acids derived from poppy seeds.

The other half received HSG with water.

The Results

Nearly 40% of the women in the oil group, and 29% in the water group all conceived within 6 months. This is an amazing result. It shows immense promise.

Of course, more needs to be known, as I mentioned before. An underlying understanding of science, safety of flushing fallopian tubes and other important, fundamental considerations remain. However, for women and families struggling with infertility, this study shows great promise.

References: 

  1. The MNT Article: http://www.medicalnewstoday.com/articles/317532.php
  2. The NEJM Publication: http://www.nejm.org/doi/10.1056/NEJMoa1612337
  3. Image Courtesy, Pexels: https://www.pexels.com/photo/close-up-of-hands-holding-baby-feet-325690/

Hand Osteoarthritis risk higher in women

Medscape reported on a study published on May 8 in the Journal, Arthritis and Rheumatology, that examined data collected from 1999 to 2010 to arrive at a risk prediction for women, with respect to osteoarthritis of the hand.

The Study

The study appears to be a retrospective evaluation of over 2000 people over the age of 45, in North Carolina. They used self-reports of arthritic symptoms and the participants’ X-ray imagery of the hands.

Results

For the overall population, the risk for osteoarthritis in at least one had by the age of 85, is about 39.8%

Caucasians had a higher risk of 41% and African Americans 29%. I assume here that the sub-populations were equivalent or adjusted for.

Obesity ups the risk to 47%, compared to 36% among the non-obese.

In women, the risk is 47% as opposed to men, where it is 25%.

Pain

Pain is one of the key effects of osteoarthritis. The more people use their hands, the more the pain related to osteoarthritis of the hand. This makes day to day activities challenging and a huge burden on Quality of Life.

Fighting Back

As the medscape article rightfully points out, physical therapy, occupational therapy and other precautions can help women (and men) in preparing themselves for this condition, as life spans increase and we await more permanent cures (such as gene therapies, etc).

References:

  1. The medscape article: http://www.medscape.com/viewarticle/879943
  2. The publication summary: http://onlinelibrary.wiley.com/doi/10.1002/art.40097/abstract
  3. The Arthritis Foundation on Osteoarthritis: http://www.arthritis.org/about-arthritis/types/osteoarthritis/
  4. Image Courtesy, Pexels: https://www.pexels.com/photo/silhouette-woman-hand-holding-heart-shape-against-orange-sky-256809/

GOC2: A PRO study on open vs. minimally invasive endometrial cancer surgeries

MDedge and MDLinx separately alerted me to a very interesting study based on GOC 2 (Gynecological Oncology), a Canadian research program. In this particular study (cost comparisons  apparently will be reported separately – MDedge has a video of an interview of the study lead), open surgery for Endometrial Cancer was compared to laparoscopic and robotic surgery techniques. The study was reported at the Society of Gynecologic Oncology 2017 Meeting.

This study is another example where women were recruited across multiple sites, and they answered survey questions, and thus, is a Patient Reported Outcomes (PRO) study on Quality of Life (QOL) following procedures of varying invasiveness.

As a reference, Endometrial Cancer represents about 3.6% of all new cancer cases in the US, occurring as new cases in an estimated 61,380 women in 2017, with a projected mortality for about 10, 920 women. The 5 year survival rate is approximately 81.3%, making Quality of Life an important concern for survivors. An NCI link is available below if you wish to explore more.

The Current Study

Patients with confirmed stage I or stage II endometrial cancer  were recruited across 8 centers in Canada. 106 patients from the open surgery arm, and 414 from the minimally invasive surgery arm participated, with the breakdown amounting to 168 laparoscopic and 246 robotic surgery patients.

Approximately 80% of patients completed the QOL questionnaires. Only about 25 – 50% of the patients responded to the sexual-function questionnaires. Those responding were found to be young, pre-menopausal and sexually active.

The study itself was not randomized, but adjustments were made to accommodate this.

Also, quoting Dr. Ferguson from MDedge below, about sexual function:

Both of the surgical groups “met the clinical cutoff for sexual dysfunction” on the Female Sexual Function Index questionnaire, she said.

Results

The results can be viewed as three distinct sets:

  1. There was no statistical significance in QOL or sexual function, between laparoscopic and robotic procedures.
  2. At 3 weeks, patients in all groups fared better in terms of pain, but Quality of Life was worse for Open Surgery Patients. Novel to this study, this extended to the 3 month period as well, both clinically and statistically. (Please watch video on the MDedge link)
  3. While fewer patients responded to the questionnaires on sexual function, there was no significant difference between the open and minimally invasive surgery groups for up to 26 weeks. I am puzzled by this honestly. If you have reduced Quality of Life, your sexual function ought to be reduced. If it is not, then how would you have a significant difference in one case and not the other? The lower number of responses might be the confounding factor here, and honestly as the paper sits behind a paywall, there is only so much I can glean from reading articles and the abstract.

References:

  1. The MDedge Article (along with the video): http://www.mdedge.com/oncologypractice/article/134206/gynecologic-cancer/video-pain-and-impaired-qol-persist-after-open
  2. Abstract 51 from SGO: https://www.sgo.org/wp-content/uploads/2016/12/SGO-AM17-abstract_titles.pdf
  3. Some Endometrial Cancer Statistics: https://seer.cancer.gov/statfacts/html/corp.html
  4. Image Courtesy of Pexels: https://www.pexels.com/photo/woman-sitting-by-the-seashore-during-day-89820/

Total Body Fat Vs. Belly Fat in Breast Cancer Risk

I came across this very interesting study through a Medical News Today article (link below). The paper manuscript itself is free, but comes across as a little difficult to read on the downloadable PDF version , because of the way it appears to be output by the journal. However, it is always good to be able to access the full paper, and not simply the summary.

The premise

Among several risk factors, body fat is a breast cancer risk. There apparently have been contentions about where specific biomarkers that indicate breast cancer are produced, with some previous studies. This study has shown that overall weight loss is more beneficial in terms of breast cancer biomarker production reduction, rather than focusing on belly fat alone.

The current study

The current study is limited to post-menopausal women. Conducted in the Netherlands, 243 overweight women were recruited. They lost 5 – 6kg over a period of 16 weeks. A set of biomarkers, indicative of sex hormones, leptin and inflammation were compared before and after the weight loss. The fat changes themselves were measured using X-ray and MRI scans.

The latter appears to be important. The MNT article includes a statement that this study is different than previous ones that used waist measurements. I can see this being quite an important difference. X-rays and MRI scans definitely appear to be more fastidious methods of assessing fat changes, specific to a body region.

Results

Increased belly fat, according to Dr. Evelyn Monninkhof, the lead in the study indicates, increases the risk for several chronic diseases, independent of total body fat. She indicates however, that sex hormones, are more affected by total body fat and not just localized fat, as concluded from the study.

She also points that their next steps is to look at how to reduce levels of total fat and abdominal fat. This said, it appears that women, especially those postmenopausal and those approaching menopause can benefit from exercise and nutritional changes that lead to total fat loss, and hopefully, abdominal fat loss along the way. It is always important to contact licensed medical and/or nutritional professionals when considering exercise and/or dietary changes.

References:

  1. The MNT Article: http://www.medicalnewstoday.com/releases/317498.php
  2. The Endocrinology Paper: http://erc.endocrinology-journals.org/content/early/2017/05/16/ERC-16-0490.abstract?sid=9f3c9977-0e81-4583-bdf5-07b3f182f911
  3. Image Courtesy, Pexels: https://www.pexels.com/photo/woman-with-umbrella-on-beach-247304/

Early Menopause and lack of child birth increase risks for Heart Failure

Heart Health in Women has many risk factors associated with it. A new study, another retrospective one, examined 28,516 women, who were enrolled as part of the Women’s Health Initiative (link below), a great effort that is now providing invaluable statistics that can be used to identify root causes and create awareness.

Eliminating all other known factors, such as BMI, smoking etc., two new factors popped up:

  1. Early Menopause
  2. Lack of pregnancy

They also identified that for every year’s worth of delay in menopause initiation, a woman’s heart failure rate drops by 1%. The other risk is caused by nulliparity, or lack of pregnancy. I am quoting directly here:

The latest study also found that women who had never given birth were 2.75 times more likely to have diastolic heart failure than women who had children.

The study authors did not establish a direct causal link, but they were able to identify a statistical link. The lead author did mention that polycystic ovary syndrome (a blog post for another day) has been known to increase cardiovascular risk. Diastolic Heart Failure happens when the heart is not able to pump enough blood to the body.

Study Limitations

Retrospective studies, especially ones based on efforts such as the Women’s Health Initiative, where large amount of data can be a treasure trove of information, just as this study has been. However, there are limitations. The current study only shows an association, not a causation, and no clues on the actual causation.

Such limitations however can be overcome by future studies, that focus on trying to identify causes.

Mitigating Circumstances

The more causes that are identified for the risk of heart failure, the better. Instead of considering these things in a negative light, women and doctors can better prepare ahead, taking precautionary measures ensuring a long and fruitful lifespan. It is also true that women in this century, prefer to make their life choices and therefore, knowing that avoiding pregnancy means a need to plan and prepare ahead for optimal health is always very good!

References:

  1. The study (sits behind a paywall): http://www.sciencedirect.com/science/article/pii/S0735109717367694
  2. The Guardian Article summarizing the study: https://www.theguardian.com/science/2017/may/15/earlier-menopause-puts-women-at-greater-risk-of-heart-failure-study-shows
  3. The Women’s Health Initiative: https://www.nhlbi.nih.gov/whi/
  4. Nulliparity: http://medical-dictionary.thefreedictionary.com/nulliparity
  5. A simple review of early menopausehttp://www.webmd.com/menopause/guide/premature-menopause-symptoms#1
  6. Diastolic Heart Failure: http://www.webmd.com/heart-disease/heart-failure/tc/diastolic-heart-failure-topic-overview#1
  7. Image Courtesy, Pexelshttps://www.pexels.com/photo/sunset-hands-love-woman-5390/

Obesity is a risk factor for IUD Expulsions

This is National Women’s Health Week. I am trying to highlight key health-related news all week. This night’s post also comes from the latest ACOG 2017 meeting from last week.

Obesity

Obesity is already a risk factor for various health conditions, such as diabetes, cardiovascular diseases and so on. For long term, reversible contraception, it is recommended that obese women opt for IUD over oral pills or patches, as the chances of venous thromboembolism is higher in obese and overweight women, than in women of normal weight. Please see referenced link below. It is an earlier paper by the same lead author/group as the current one, coming from Hawaii.

Weight classification, takes women and men from underweight to normal weight, overweight and obese. Within obesity, depending on waist size, the classification goes from Class I to Class III, representing extreme obesity. I have attached an NIH reference for your convenience.

It appears that in women with Class III obesity, IUDs can shift inside the uterus, also commonly termed IUD expulsion, at a higher rate than in women of other weight classes. This was the focus of the presentation at ACOG last week.

The current study

A retrospective cohort study, in Hawaii, with access to a diverse population including approximately a third each of Asian women and Native Pacific Islanders, has shown that obese women with Class III obesity have a risk, that is 3.06 times other women. Read other details in the paper summary and the article linked below.

Theories

The study itself was only performed, retrospectively to titrate risks. Some theories have been presented by the authors.

Placement itself might pose difficulties because of obesity.

Another risk of obesity is heavy menstrual bleeding, and therefore, IUD expulsions might be encouraged.

The authors however continue to encourage the use of IUDs in all women, regardless of body weight, as the benefits outweigh risks.

Conclusion

While on one end, further studies are needed, and will likelihood indicate why IUD expulsions occur at a higher rate in obese women, women should not stop opting for IUDs.

Additional studies that describe the causes for IUD expulsion might indicate that it is solely not a function of obesity, and it has already been shown that obesity is but one risk factor for expulsion.

Knowing why IUDs dislodge or move would make for better IUD design! 

Until the reasons are known and designs could be potentially improved, for the long term, women should focus on efforts that help them lose weight, in a healthy and practical manner.

References:

  1. ACOG Presentation Summary: http://mobile.journals.lww.com/greenjournal/Abstract/2017/05001/Levonorgestrel_Intrauterine_Device_Complications.235.aspx
  2. A previous article by the same group: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4642497/
  3. The mdedge article http://www.mdedge.com/clinicalendocrinologynews/article/137744/gynecology/beware-hormonal-iud-expulsion-obese-women?channel=261&utm_source=News_CEN_eNL_051317_F&utm_medium=email&utm_content=Are%20some%20obese%20women%20having%20issues%20with%20IUDs?
  4. NIH Weight Classification: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi_dis.htm
  5. Some information on IUD Expulsion and what to do: http://www.healthline.com/health/birth-control/iud-fell-out#5
  6. Retrospective Cohort Studies: https://en.wikipedia.org/wiki/Retrospective_cohort_study
  7. Image Courtesy, Pexels: https://www.pexels.com/photo/backlit-beach-dawn-dusk-227674/

Delay in Breast Cancer Diagnosis and Increase in Mortality

In the United States, it is National Women’s Health Week. I am going to try to post about a different and key area of Women’s Health through this week.

Today, I am going to point you to the summary of some important results from a very interesting paper on breast cancer diagnosis delays. I only have the summary to offer as the paper itself sits behind a pay wall. Still, even the summary should give one pause and suggestions of key demographics to aim at, in trying to bring up the diagnosis.

Study Limitation

This study, like the one mentioned in yesterday’s blog is also an ecological study and therefore, does not have the strength and rigor of a prospective, clinical study. However, the study results are still very valuable and informative.

Summary of Key Findings (Quoted)

Delays in diagnosis could possibly affect survival as well. While it is possible to quote from the summary, the mdedge article that originally pointed me to the paper has a nice summary, and I am going to quote it here. The article itself is linked below:

  • Women who received Medicaid or were uninsured were more than twice as likely to be diagnosed at a later stage, vs those with commercial insurance.
  • Blacks were 18% more likely than whites to experience such.
  • Unmarried women were 25% more likely than their married counterparts to be diagnosed later.
  • Younger patients were 25% more likely than older individuals to experience delayed diagnosis.
  • Compared with commercially insured patients, death rates from breast cancer in Medicaid and uninsured women were 40% and ~60% higher, respectively.
  • This rate was nearly 40% higher in blacks vs whites, and nearly 20% higher in unmarried vs married women.

Conclusion

As you can see, social status, insurance, and even marital status as well as age make significant contributions to delay in diagnosis. Similar issues exist with survival and mortality. As the authors state in the study, it is important to explore these demographic and social status differences further. When separated by sex, Breast Cancer is the leading cause of cancer based mortality among women in the United States. Every effort must be made to ensure increased awareness, early diagnosis and treatment of breast cancer!

References: 

  1. Summary of the Study: http://onlinelibrary.wiley.com/doi/10.1002/cncr.30722/full
  2. The mdedge article: http://www.mdedge.com/oncologypractice/clinical-edge/summary/practice-management/these-factors-impact-breast-cancer?group_type=2-month&topic=278&utm_source=News_Power_eNL-B_051417&utm_medium=email&utm_content=ClinicalEdge%20Top%2010:%20Editor%27s%20Picks%20for%20May
  3. Image Courtesy, Pexels: https://www.pexels.com/photo/woman-in-black-tank-top-holding-an-umbrella-in-front-of-yellow-concrete-wall-57851/

A seemingly surprising increase in incidence of Endometrial Cancer

The ACOG 2017 saw several interesting results come out. One surprising result, presented at an oral presentation, appears to be a presentation about the increase in the incidence of Endometrial Cancer.

It appears that Endometrial Cancer rates were stable from 1999 to 2002, but then, since 2006 to 2014, the rates appear to have increased by 10%.

The authors were curious, as you and I might be, so they examined EC incidence through the Surveillance, Epidemiology, and End Result Program database from 1975 through 2014.

Factors affecting Endometrial Cancer

It appears that FDA approved hormonal therapies have dropped in number, and therefore the use of non FDA approved combinations of estrogen and estrogen+progesterone, which may not be enough to stop endometrial cancer.

Obesity, which has been increasing consistently, already a known risk factor, might be aggravated.

Study Limitations

The study, as stated by the authors themselves, is clearly not a randomized clinical trial, but an ecological study. Therefore, it is not sufficient to draw conclusions and yet, the findings, especially the coincidence of the use of non-approved hormonal therapy and the increase in endometrial cancer as well as factors such as obesity is quite interesting, and this should be flushed out further, perhaps with targeted studies. Women, in particular should be aware of risk factors and seek medical help in advance.

References

  1. A report on the study: http://www.mdedge.com/clinicalendocrinologynews/article/137805/gynecologic-cancer/endometrial-cancer-rates-increased?channel=247&utm_source=News_CEN_eNL_051317_F&utm_medium=email&utm_content=Are%20some%20obese%20women%20having%20issues%20with%20IUDs?
  2. The ACOG summary of the study: http://journals.lww.com/greenjournal/Abstract/2017/05001/Increased_Incidence_of_Endometrial_Cancer.19.aspx
  3. Image Courtesy, Pexels: https://www.pexels.com/photo/beach-woman-sunrise-silhouette-40192/

Some secrets of the relationship between Vitamin D and Calcium Intake to Early Menopause revealed

A Cholla Dusk

Early Menopause

Early Menopause is generally detrimental to a woman’s health and mental well being. Thus it is important that factors that delay early menopause are exposed and women are prescribed appropriate remedies.

Limitations in the reported study

This particular study (link below) tried to differentiate Vitamin D and Calcium intake through food and through supplements. The article that talks about this study reveals some key limitations of the study, with respect to the number of people who take large quantities of supplements, enrolled as well as the fact that the subjects are predominantly Caucasian. Because the diet data was self-reported, that offers a problem as well. It is a little saddening to see an NIH funded study take on such a form.

They did account for factors such as smoking, alcohol, BMI etc.

For many of the explanations though, there are only theories and hypotheses offered. This, I am sure, is because it will take thorough, large scale studies before they can be proven.

Interesting Results

Despite the fact that at least the article tries to conclude that food-based intake of Calcium and Vitamin D is the primary driver of the push-back on early menopause, as opposed to supplemental intake, I am not sure the study lays this out for us to subscribe to, with enough confidence.

In general, it appears that taking in recommended levels of Calcium and Vitamin D, either through food, supplements, or in the case of Vitamin D, safe exposure to sun (a problem for Caucasians with their high risk to skin cancer, and perhaps a factor in the recruitment for the study, which if true, is perhaps explained better in the paper, which unfortunately sits behind a paid wall), reduces the risk of early menopause.

Conclusion

As stated, early menopause comes with significant health and financial burden to the women and health systems in the general. Therefore, not only should the results of such studies be used, they should be expanded to solidify evidence, and diversify it based on race and other factors.

Reference:

  1. A summary of the study: http://www.medpagetoday.com/endocrinology/menopause/65189

Some results on breast reconstruction following mastectomy

The Preface

One of my life goals, and specifically, as it pertains to this site, is to spread the news about free and open, well composed, peer-reviewed scientific publications. Following that tradition, today’s blog focuses on another key area of women’s health – breast cancer, mastectomy and post-mastectomy reconstruction.

The Paper

ASCO and MedPage Today are reporting this paper in the Journal of Clinical Oncology, available on MedPage Today for free (link below), that highlights one year, post operative patient survey results, that highlight differences in satisfaction with breasts, among women who opted for two forms of breast reconstructive surgery.

The two forms are Autologous Recovery or Flap Recovery and Implant Reconstruction.

Autologus Recovery

Autologous Recovery, as some of you might guess, involves tissue from the patient’s own body, reconstructed and used as breast tissue. There are two types of tissue recovery possible: free flap, where the tissue is severed from its blood vessel connections and moved or, a pedicled flap, where the blood vessels are still attached as the tissue is moved. Tissue usually arises from areas such as the belly or the back. A link with details is supplied below.

Implant Reconstruction

Implant reconstruction doesn’t last a life time, the key difference between this and autologous recovery, and may need multiple surgeries. Usually composed of silicone and saline, these implants are sized and implanted into the body. This method is less invasive, and easier with delayed reconstructive options, and provides the patients with multiple breast shape options, allowing for the most suitable form to be chosen and used. Formerly, this was the best option for women with smaller breasts, because they also usually had less tissue available for reconstruction, but autologous recovery has made strides in this area, so this is no longer seen as a big advantage. Refer to the link below for more information.

The present study

The present study enrolled a large number of patients, 1632, in total, across 11 sites; that were undergoing immediate postmastectomy reconstruction for either invasive cancer and/or carcinoma in situ. There is some argument over whether carcinoma in situ is actually cancer. Regardless of the status of this debate, this is the title for a group of cells/tissue that is precancerous and has not metastasized but is expected to. This is common in breast and a few other cancers, and patients many times choose to undergo mastectomy to fend off cancer.

Patient Reported Outcomes (PRO)

The study was conducted by evaluating Patient Reported Outcomes, also known as PRO. This is a method where validated questionnaires are used, to assess treatments and/or symptoms, from the patients’ perspectives, going beyond clinical measurements, which, for the longest time where the mainstay of medical comparative evaluation. There are barriers to the prevalence of PROs, as internet access, data availability, etc. remain challenges, however it is becoming an accepted research form, especially where patients themselves would be the best judges of outcomes.

Care must be taken when interpreting patient reported outcomes, valuable as they are, and especially so, when using them for labeling claims. The FDA has also weighed in.

In this study, using  a generic PRO measure, Patient-Reported Outcomes Measurement Information System–29, patients were quizzed before, and one year after surgery. If you want to read and learn more about PROMIS, I have appended a link below.

The Results and Conclusions

Using the scoring system, and based on the response of 1183 patients, the researchers concluded that patients with Autologous Recovery/Reconstruction had better satisfaction  with their breasts and mental well being. Anxiety and depression were reduced in both groups, however, neither group had fully recovery of chest health. There was increased pain with Autologous Recovery, while patients with Implant Reconstruction had reduced fatigue. overall, it appears patients who underwent Autologous Reconstruction had a slight edge. I have attached links to the summary and the article below.

References:

  1. The ASCO study summary: https://www.medpagetoday.com/reading-room/asco/breast-cancer/64962?xid=NL_ASCORR_2017-05-11&eun=g5100781d39r&pos=1111 Note: The full paper link is available on the same page. 
  2. Autologous Recovery: http://www.breastcancer.org/treatment/surgery/reconstruction/types/autologous
  3. Implant Reconstruction: http://www.breastcancer.org/treatment/surgery/reconstruction/types/implants
  4. PROMIS: http://www.nihpromis.com/?AspxAutoDetectCookieSupport=1#1
  5. A Paper on Patient-Reported Outcomes: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227331/
  6. Carcinoma in situ: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=46488
  7. FDA Guidance on the use of Patient-Reported Outcome Measures: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf
  8. Image Courtesy, Pexels: https://www.pexels.com/photo/flower-pink-peony-blouse-112324/

 

Key evidence in support of breastfeeding and breast milk!

Culturally, breastfeeding has variable patronage. Some people are still backwards enough to wish to restrict breastfeeding in public as a moral issue. This is purely nonsensical. Then there are those who have actually debated reducing breastfeeding time. Science, stands in opposition to all such fallacies.

And today, Physican’s Briefing highlighted this amazing study coming out of Los Angeles and St. Petersberg Florida, and published in JAMA. I browsed through the paper, available as a free download (link below), always a great thing! This paper will be featured on my medical journal site soon. It is simply great. The analysis methods, the various permutations and combinations examined, etc. make it all the more impressive, and with just basic science training, you are able to follow the fundamental methods and findings quite easily. But, more on that later.

This remarkable study, spanned 5 years, two centers, and 107 healthy mother-infant pairs, some mothers only and infants only, carefully screened, followed up, and analyzed! The attention to detail at every level makes this a really great paper. For the first time, it links breast milk and the areolar skin (skin in the mother’s nipple area, please see excellent Wikipedia reference below) to infant gut bacterial colonies.

Rather than try to interpret and potentially mangle findings, I am going to just quote the clear language from the paper directly:

Question  Do maternal breast milk and areolar skin bacterial communities transfer to the infant gut?

Findings  In this 12-month longitudinal study of 107 healthy mother-infant pairs, breastfed infants received 27.7% of their gut bacteria from breast milk and 10.4% from areolar skin during the first month of life. Bacterial diversity and composition changes were associated with the proportion of daily breast milk intake in a dose-dependent manner even after introduction of solid foods.

Meaning  Microbes in mother’s breast milk seed the infant gut, including those associated with beneficial effects, underscoring the importance of breastfeeding in maturation of the infant gut microbiome.

Conclusion

If there was ever an argument against breastfeeding, it should evaporate away with this study. More importantly, it ought to create a sense of urgency in helping women understand the need and importance of breastfeeding, as well as awareness on the appropriate duration of breastfeeding infants.

References:

  1. The Physician’s Briefing Articlehttp://www.physiciansbriefing.com/Article.asp?AID=722478
  2. The JAMA Articlehttp://jamanetwork.com/journals/jamapediatrics/fullarticle/2625334
  3. Wikipedia on Areola: https://en.wikipedia.org/wiki/Areola
  4. Image courtesy, Pexelshttps://www.pexels.com/photo/crescent-moon-and-cloud-wind-chimes-235243/

On women and blood clots

The National Blood Clot Alliance alerted me to two things today, through a news release:

  1. May 14 – 21 is National Women’s Health Week in the US, something that the HHS started a while ago. Who knows how long it will last, and perhaps maybe we should turn this into a regular thing sans government impetus, going forward.
  2. There is a risk to blood clots for women from many forms of hormonal birth control, which they should be aware of.

Clot Risks

It is true that women suffer from clot risks throughout their life. The risk is lower for younger women, compared to older women. Even considering contraceptive use it is low. Please see the NIH reference below. The use of contraceptives does increase this risk in women of child bearing age, and the consequences of blood clots include both morbidity and mortality, and therefore, it is important that there is ample awareness of these risks.

Creating Awareness

The National Blood Clot Alliance along with  Alexandra L. Rowan Memorial Foundation, another excellent organization I learned about today, are asking women to visit “Women And Clots”, a website, womenandbloodclots.org to learn more, access resources and use a risk assessment tool to learn more.

Please pass this on to women you know, especially of child-bearing age, so they may learn of and benefit from this resource and be aware of clot risks going forward!

And, I plan to blog as profusely as time permits during National Women’s Health Week. So consider subscribing to the Blog updates and watch this space for more!

References:

  1. The Stop The Clot Article: https://www.stoptheclot.org/national-womens-health-week-2017.htm
  2. The Alexandra L. Rowan Memorial Foundationhttp://www.alexrowanfoundation.org/about/
  3. Women and Blood Clots: https://womenandbloodclots.org/
  4. The NIH Article on Blood Clots: https://www.ncbi.nlm.nih.gov/books/NBK44181/
  5. Image Courtesy, Pexels: https://www.pexels.com/photo/selective-focus-photography2-blue-egg-on-nest-158734/

Some shocking revelations on violence and trauma during pregnancy!

The American College of Obstetrics and Gynecologists (ACOG) has its annual meeting this week, and how I wish I could be there! Maybe next year. Meanwhile, some shocking new findings are being presented at the meeting!

The results are from researchers at the Perelman School of Medicine at the University of Pennsylvania, who analyze a statewide analysis, for pregnancy related hospital trauma cases over a decade, for the State of Pennsylvania.

Please read the key findings in the link below. You may also refer to the proceedings poster.

A Couple of Shockers

The data itself is shocking, about 1 in 12 women have trauma during pregnancy, that may be due to accidents or assaults. This is also the leading non-obstetric  reason for death among pregnant women. There are the usual caveats about how pregnancy complicates everything. But, I found a couple of things really shocking! Here is one from Neha Deshpande MD, the clinical resident, who is also the lead author of the study:

“Despite the severity of the issue, little is known about how trauma actually impacts pregnant women since accidental and incidental causes of death are excluded in many statewide and national maternal mortality reviews. The striking results of our study suggest that widespread screening for violence and trauma during pregnancy may provide an opportunity to identify women at risk for death during pregnancy.”

  1. The “little is known” gave me pause and I had to re-read it twice! And, apparently not much screening of trauma and pregnancy occurs!
  2. The second thing that shocks me is that “accidental and incidental causes of death” are excluded from many state and national maternity mortality reviews! Well, there is something in need of fixing! If we don’t even do a good job of counting the causes and cases carefully, how would we proactively fight pregnancy related trauma?

Other Findings

  1. Some of the other findings were disturbing as well. The study found that injuries in pregnant women were fewer than in women who weren’t, but even with the reduced severity, pregnant women were nearly twice as likely to die! Clearly, resource availability and planning have to be increased to give immediate special care and attention to pregnant women.
  2. The next one, mental health, ignored for long, seems to be particularly troublesome when it comes to pregnant women. Nearly 1 in 5 pregnant women reported some form of psychiatric illness. What little attention has been provided to pregnancy related mental health issues, usually focuses (not that it should be reduced) on postpartum depression. Well, it appears, this attention should be increased and should span the entire pregnancy timeline!
  3. In more disturbing news, minority and uninsured women were reported be significantly more likely to experience assault. It is already reported through many channels that minority women and uninsured women have the most problems, and this makes things worse. Given the recent proposed changes to healthcare laws in the US, and the debate surrounding affordable care, and access to care, these findings are the most disturbing and alarming!

The Future?

Results from a single state, spanning a decade are commendable, as much as their findings give much cause for concern. But, what of the future? I think alongside making more resources available, and creating more awareness, a few changes are in order:

  1. Change how pregnancy related morbidity and mortality data are collected, specifically to highlight accidents and violence.
  2. As I mentioned before, make maternal mental health a central issue through the pregnancy cycle. Is there any reason to believe (and this is in no way in defense of) that both parents face mental health issues during pregnancy, and perhaps, sometimes, violence is a result? This might be important to know.
  3. Do pregnant women know how to approach for help when abused? Where to go? What treatment options are available?
  4. How would this data about pregnancy look like, if collected and analyzed globally?

This study, from U.Penn is truly an eye opener, but if anything, it tells us not enough is being done.

Reference:

  1. The MedicalXpress Article: https://medicalxpress.com/news/2017-05-pregnancy-linked-higher-death-traumatic.html
  2. Image courtesy, Pexels: https://www.pexels.com/photo/motherhood-parenthood-pregnancny-mother-59894/

Interesting MIT Research on Ovarian Cancer Detection

The teal ribbon, pictured above, is used to represent the Fight Against Ovarian Cancer

I am back to my favorite Qmed today. They led me to a neat article on MIT News.

Ovarian cancer, while rare, still affects a number of women. According to the National Cancer Institute (NCI – link below), approximately 1.3 % of women will be diagnosed to cancer during their lifetime, and in 2014, they approximated that 222,060 women were living with Ovarian Cancer in the United States.

In addition, as detailed both in the Qmed Article and MIT News (links below), Ovarian Cancer detection is challenging, and usually detection doesn’t occur well after the disease has reached a certain size.

Consequently, this represents an important challenge in healthcare, and with the support of some much needed funding and the investment of great scientific minds, MIT might have used synthetic biomarkers, that, if transferred successfully from the current mouse models to humans, can shave diagnostics time by about 5 months! And five months, can definitely mean a lot for disease detection, treatment and/or management.

Read more about synthetic biomarkers, the challenges with Ovarian Cancer detection, and other interesting information through the links below.

References: 

  1. The Qmed Article: http://www.qmed.com/mpmn/medtechpulse/better-way-find-ovarian-cancer?cid=nl.x.qmed02.edt.aud.qmed.20170503
  2. The MIT News Article: http://news.mit.edu/2017/new-technology-detect-tiny-ovarian-tumors-0410
  3. Some NCI stats on Ovarian Cancer: https://seer.cancer.gov/statfacts/html/ovary.html

AHCA: Is rape really a pre-existing condition or does Washington Post know what “analysis” means?

One of the many claims to come out of the #AHCA bill that passed the House this past week is that rape will be considered a pre-existing condition and will no longer be covered. Women’s organizations (and others; rape is not a sexually discriminatory evil) have been chagrined and have been protesting this vociferously. Therefore, for anyone who wants to jump into the argument, a little caution would be advised. And you would think that Washington Post would exercise the same or higher levels of caution. Instead, they went on an incredible trip to try and show that they are nonpartisan and focused on facts. The result is they come across as a weak newspaper, ready to suspend intellect just to accomplish an end. Let us take a closer look. The very beginning is not auspicious:

Yet the reality is very complicated, and a highly unlikely cascade of changes in federal and state law need to happen before a woman is denied insurance solely because she was raped or sexually assaulted. Let’s dig in.

Right. Even if we agree that something needs a “highly unlikely cascade of changes”, we do not need to agree that those changes are impossible. After all, just look at the times we live in.

After stating this, the author of said analysis should have said, “Okay, this is beyond me. I should stop and write about the local farmer’s market and when organic corn will be available”:

The revised GOP plan included an amendment crafted by Rep. Tom McArthur (R-N.J.), which helped the plan attract votes that led to its passage. The amendment allowed states to seek waivers from a “continuous coverage” provision that otherwise would boost insurance rates by 30 percent for one year if a person has a lapse in insurance coverage for more than two months.

Instead, if the state met certain conditions, insurance companies for one year could consider a person’s health status when writing policies in the individual market. Another possible waiver would allow the state to replace a federal essential benefits package with a more narrowly tailored package of benefits, limited to the individual and small-group markets.

That is precisely the problem with the AHCA amendment:

  1. Waivers can be sought. Why do you think States that clearly want to cut off insurance access, and absolutely want to force rape victims to bear any children (we are talking of rape victims who are women, in this case) will just wait around and NOT seek the waivers?
  2. Essentially, one of the waivers allows them to “narrowly tailor benefits”. Essentially, no abortion coverage (which is flaky anyway), definitely no Plan B contraception, or HIV Medication are all possibilities.
  3. Essentially, the two-month “lapse” is the killer, and I will give you an example. Let us say someone gets raped and physically abused so badly, they stay in Intensive Care for a solid couple of months. These things, VERY UNFORTUNATELY, do happen. They slip on their payments. Lo! The State and the Insurer can now essentially change the patient’s coverage. Which way the coverage will go is really not a mystery, unless, I suppose you work for Washington Post.

The most egregious quote in this vile, misguided “analysis” ensues:

The AHCA does not specifically address or classify rape or sexual assault as a pre-existing condition. It also would not deny coverage to anyone because of a pre-existing condition.

The entire premise of the above-stated McArthur amendment WAS to gain the votes of House members who specifically wanted to see the pre-existing condition coverage gutted. Formerly, I thought it would take an enormous amount of ignorance and uneducatability to fail to see this. I don’t think so any more, given the evidence presented above.

What I don’t understand, and apparently, many of those commenting don’t either, is how can someone say one thing and then try to peg the opposite interpretation to what they JUST said:

States and the Secretary of Health and Human Services would decide how to interpret “health status.” State waivers must be approved by the federal government. Opponents of AHCA say that because “health status” is up for interpretation, there is no control in the bill to prevent rising costs for survivors of rape and sexual assault.

Exactly what do you think would motivate a Federal Government to give itself pause from rubber-stamping State Government Waiver requests when they are of the same party and their interests are aligned? Does this ever happen?

And yes, opponent or not, “health status” HAS been opened up for State interpretation. Given recent egregious comments coming out of places like Oklahoma (the latest in a long string of such comments), it is extremely foolish to think that rape victims will receive the same protections as before, should AHCA become law.

At least 45 states have laws prohibiting health insurance companies from using a woman’s status as a domestic violence survivor to deny coverage, according to the National Women’s Law Center.

When you want to look at the moon and see a wolf, all you have to do is “visualize”. So, just before this quote, the brilliant author of said analysis, says virtually every state, without realizing that to begin with, 10% of the States in the US do NOT have this provision in place.

Secondly, how does one fail to see the problem here? Insurance companies and state insurances will not need to “deny” coverage. They can just make your coverage prohibitively expensive. This has precisely been the modus operandi for decades and hence the name AFFORDABLE CARE ACT and NOT Obamacare, as only idiots (and this is the term our storied analyst uses in the gibber-fest by the way) refer to it, when writing formally.

The whole premise of ACA all along has been affordability of insurance, besides its accessibility. It federally bound insurers and states from colluding and letting patients with serious, or politically charged health conditions (or statuses) just fend for themselves or die. And even that wasn’t effective. Religious organizations found themselves able to waive (though coverage came through other means) covering conditions unpleasant to them. This is precisely what AHCA guts. This is why several organizations are opposed to it!

Bottom line: Almost all states (at least 45 to 48) have their own laws protecting survivors of domestic violence and sexual abuse. Even if AHCA became law as currently written, state law still determines what can and cannot be used for rating, according to the National Association of Insurance Commissioners.

Yes, when it comes to strategic planning for the security of hen houses, consult the FOX! 

Conclusion: The problem here is simple. Several religious organizations and states have a febrile, maniacal desire to cut coverage for rape victims. To simply deny yourself the acknowledgement of this, or to simply build on your inability to understand this, and to then go on and write nonsensical arguments IN THE FACE of links you yourself posted is stupid.

I see a trend with newspapers such as The New York Times, Washington Post etc to desperately appear non-partisan. And it appears, they will just make themselves open to much mockery to get there.

I, for one, am happy that I do NOT subscribe to the Washington Post and this uneducated, unworthy, despicable, ignorant, narrow-minded rant, has made me further my resolve to stay away from the publication.

Remember, men and women, both can be sexual assault victims. We all need to stand in support of the prevention of rape, the elimination of cultural attributes that use religion or any vile argument to make rape sound any less disgusting than it is, and to stand by the unfortunate victims of rape.

References:

  1. The deplorable “analysis”: https://www.washingtonpost.com/news/fact-checker/wp/2017/05/06/no-the-gop-health-bill-doesnt-classify-rape-or-sexual-assault-as-a-preexisting-condition/?utm_term=.af7d521e09b5#comments
  2. Image courtesy, Pexels: https://www.pexels.com/photo/ask-blackboard-chalk-board-chalkboard-356079/

No, one pregnancy does not make Mirena or other IUDs useless

It is important to remember that the best source of advice is your Obstetrician/Gynecologist/Doctor, and regardless of all your research, you should always consult them for medical advice! 

The Backstory

Always on the look out for interesting medical device news, I came across this apparently humorous story of a baby, born through a pregnancy that occurred about 3 weeks (this is only an assumption based on what the mother herself has predicted) after the placement of a Mirena IUD.

The humor supposedly lies in the fact that the Obstetrician fished out the IUD, which was difficult to find and remove during the pregnancy, while the C-section was being performed. A nurse then put the IUD on the baby’s hand and captured an image with one of the ubiquitous smartphones, shared it, and the image then went “viral”.

What Ensued

Due to stiff competition among manufacturers and variable experiences from patients, Mirena, and IUDs in general, are discussed on and off, with their capabilities challenged. An incident such as this pregnancy always bring up questions, many fair, and many not. It is important that they be addressed, nevertheless.

I have always maintained, even in my earlier blog posts (one is linked below) on my main Medical Devices blog, that IUDs are the easiest and least invasive ways to prevent pregnancies, when compared to other devices.

Planned Parenthood appears to claim that IUDs are 99.9% effective. Now, I would be cautious even with the force of Planned Parenthood behind the statement. A pregnancy that was already initiated, hormonal imbalances or physiological oddities, improper placement, any number of things could potentially cause a pregnancy.

Even with both partners exercising birth control measures, you could still have a pregnancy!

Some Caution for Device Designers

People see the humor in the situation, but a health practitioner and a device designer/engineer should see something worrisome here. Of course, reporters (link below), don’t always know how to accurately represent information, but I find this particular sentence of concern:

The doctor was unable to remove the implant during her pregnancy, but while delivering the baby, Hellein said he found it behind her placenta.

Note: Hellein is the mother.

There are at least one of two things going on:

  1. It was simply difficult or impossible to remove the IUD during the pregnancy.
  2. It is possible that it was impossible to remove the IUD because it could not be found!

Understandably possibility no. 2 is quite worrisome. Without knowing much though, I cannot tell whether the IUD needs to have features that make it obvious during an X-Ray, Ultrasound or other imaging technique, preferably, an imaging modality whose radiation levels don’t present risks to mother or child.

Opportunities and Challenges

If the IUD is difficult to find due to anatomical challenges, whether they arise from a pregnancy or not, there is an opportunity to improve the design of IUDs. What form this might take is hard to say, and one thing to consider is, that the methods that help make the device visibility should be biocompatible and should in no way threaten the patient or any potential babies.

Further Issues

Here is something else from the article that gives me pause:

“This woman is very lucky that when the placenta grew over the IUD it did not disrupt the blood flow to the placenta,” Ghasseminia said.

She said this could lead to a miscarriage.

Laura Ghasseminia, is apparently a Planned Parenthood nurse practitioner, interviewed for the story by 10 News (link below). What she said here, gives one further pause. It is difficult to conceive, but it could be possible to design an IUD that  somehow loses flexibility or its shape once it dislodges from its location, whether due to a fertilized fetus, or due to some other reason.

All said, there are some challenges that this pregnancy and the “miracle baby” have unearthed, and this requires further consideration!

References: 

  1. The News Story Quoted Above: http://www.wtsp.com/news/exclusive-baby-born-holding-mirena-iud-mom-sets-the-record-straight/436603932
  2. An old blog post of mine: http://chaaraka.blogspot.com/2007/09/womens-health-devices-heat-upslowly.html
  3. Image courtesy, Pexels: https://www.pexels.com/photo/adorable-baby-baby-feet-beautiful-266011/

 

Vaginal Meshes, the enduring saga!

Vaginal Meshes, originally conceived, perhaps with good intentions, have become quite the source of trouble for the women who opted for these devices to be implanted in them. Years and years of lawsuits, with multiple companies settling and fighting them, would, you think, put a damper on the product, but no! The saga, ensues, and shows no signs of ending!

I came across this bit of news today. Not only is J&J fighting back on a recent judgement against it, the company is going ahead with more clinical trials.

New Design or Brave Face?

The most recent judgement against J&J, is to the tune of $20mn, $17.5mn of which are punitive damages, in Pennsylvania. It makes sense that given the amount and the fact that it is a State verdict, that J&J would fight it.

Part of their reasoning to fight the judgement is that, they believe the Ethicon Design was not flawed. And yet, about 5 years ago, they pulled the product from the market, apparently only owing to the negative publicity (well placed, if you ask me) for vaginal meshes, and not owing to bad design. And, if you read the history, (see link 3 under references below) you will find out the excision of the device from the market (easier than excision from the body) was not exactly voluntary.

Then why redesign the vaginal mesh at all?

And, it is not as if all the negative publicity has gone away. So, why would the public suddenly change their mind now?

In part, I think all this talk about the new design is perhaps, just a brave face effort, to fend off future lawsuits, of which, I am sure, there will be many. If not, it must be the notion that the vaginal mesh will still prove to be a viable device, despite all the hands in the cookie jar, and J&J should not lose the edge. Patents, PMAs and clinical trials after all, create a high barrier for entry to any uppity start-ups that come along with design improvements…

The real culprit

Vaginal meshes treat vaginal prolapse, the collapse of the pelvic vault, and stress urinary incontinence (SUI), arising from muscular dysfunction (loss or impedance of function). Vaginal prolapses, often occur as a consequence of hysterectomies. Quite a significant number of hysterectomies are unnecessary, and are performed in preference to lesser invasive treatments, as hysterectomy is well covered by insurance companies! The hysterectomies, in effect lead to complications, such as prolapse, which then need either surgery or mesh implantation and on and on it goes.

If we reduce the haphazard use of hysterectomies as the nuclear weapon that kills ants, then we automatically improve the chances of preventing and/or delaying prolapse altogether, in which case, you wont have a number of suffering women across the country, lawsuits and incredibly uncouth late night television ads on vaginal mesh lawsuits!

References: 

  1. The J&J Verdict: http://www.qmed.com/mpmn/medtechpulse/jj-will-fight-20m-vaginal-mesh-verdict?cid=nl.x.qmed02.edt.aud.qmed.20170503
  2. The Mayo Clinic on Vaginal Mesh Complications: http://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300
  3. History, Notes on Complications, etc: https://www.drugwatch.com/transvaginal-mesh/
  4. Image courtesy, Pexels: https://www.pexels.com/photo/black-microphone-windscreen-158736/

 

Quick Post: Boston Scientific’s efforts to enroll more women in medical device trials

I love Qmed. They provide great news updates all the time. This morning, I came across an important bit of news through one of their newsletters.

Boston Scientific apparently has an initiative called WIN-Her. Marketing must have gone into a frenzy to come up with this, which, expands to:  Women Opt-In for Heart Research.

Boston Scientific points to research (link, obtained through BSC press release, below) that indicates that only one-third of patients enrolled in a cardiovascular clinical trial between 2000 and 2007. I am sure there is not much reason to believe the situation has improved much.

They are now using this program of theirs to enroll more women in two of their own clinical trials (please see links below). It is very important to know if women and men experience the effects of devices and treatments differently, and for this, it is key that enough women be enrolled in clinical trials for non-sex specific health conditions. However, major barriers exist. This is a theme that I will expand on this blog extensively, over time.

There is of course the added benefit that it makes the sales of devices, proven by clinical trials, that much easier and the prospects of profits higher!

It is true that women not only have lesser access to healthcare, they are also not given information about the possibilities of clinical trials, treatment options and so on. As pointed out, in the Qmed article, logistical challenges in clinical trial participation are already high, and for women who might have income barriers, transportation and continual access issues, this probably makes things worse.

Only a concerted effort by industry, academia, hospitals, non profits (including, organizations like Planned Parenthood) and the various levels of Government can help ensure enough women enroll and participate in clinical trials. This is true of not just cardiovascular health conditions, but all health conditions.

On a slightly different note, I found this interesting read about a Stanford University Undergraduate Student who survived AML, and apparently, enrolling in a clinical trial helped the young lady who wrote the blog post, furthering the argument that it is very important that women of all walks of life be encouraged to join clinical trials where feasible.

References:

  1. Image courtesy, pexels: https://www.pexels.com/photo/view-of-operating-room-247786/
  2. The Qmed article: http://www.qmed.com/mpmn/medtechpulse/can-boston-scientific-woo-more-women-clinical-trials?cid=nl.x.qmed02.edt.aud.qmed.20170502
  3. The Boston Scientific Press Release: http://news.bostonscientific.com/2017-04-18-Boston-Scientific-Initiates-Global-Study-To-Assess-Sudden-Cardiac-Arrest-Prevention-Therapy-In-Patients-With-Diabetes-Who-Have-Previously-Experienced-A-Heart-Attack
  4. The gender bias paper mentioned by Boston Scientific: http://circoutcomes.ahajournals.org/content/4/2/165.long
  5. The blog post by the AML survivor: https://medium.com/stanford-magazine/i-didnt-beat-cancer-my-doctors-did-ec6c3a92d426

A truly elegant innovation helps menstruating women in India

South Asian Woman

My goal with gyn.io is to highlight women’s health issues and relevant solutions. What better way to do this, than to talk about a truly remarkable gentleman, Mr. Arunachalam Muruganantham, with an equally amazing innovation. I am thankful to my friend Tania Marker for having shared this news with me. Her main motivation in doing so, is that Arunachalam is from Coimbatore, India, my hometown, which only makes this all the better!

I am a little peeved that I had not heard about this gentleman before, but I am not wholly surprised, as, in the article linked below states, menstruation is not discussed well in India, and has quite a bit of stereotyping and taboo around a very natural process.

From understanding the need for sanitation during menstruation, to obsessing over a solution, and discovering that sanitary napkins are made with cellulose and figuring out how to get it right, this is an incredible story of ambition, persistence and of course, innovation!

Hats off, Arunachalam!

Reference: 

http://www.pbs.org/newshour/bb/innovator-trying-make-sanitary-pads-affordable-women-india/

Image, Courtesy: 

https://www.pexels.com/photo/colourful-india-wedding-indian-16154/