Category Archives: Medical Devices

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/

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/

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/