US: National Women's Health Week is here

In the United States, May 14 - 20 is National Women's Health Week this year, at least I guess because the funding hasn't been pulled yet. HHS has a website specifically dedicated, with suggestions for women of various ages on what they can do to improve their health. A link is available below.

Introducing gyn.io

Recently, I started a project of my own, with no intention of coinciding with the commemoration. Nevertheless, I think the timing is opportune. I have always wanted to write about and expand on my interest and experience in Women's Health.

Gyn.io is a blog/resource site on which I have started blogging about Women's Health issues, and through this week, I hope to write a post a day, highlighting a unique area or problem in Women's Health.

Please visit, sign up for updates and do leave me feedback, areas for improvement and/or posts you'd like to see on the site.

Here is the link: http://gyn.io

Also, a link to the HHS Website: https://www.womenshealth.gov/nwhw

Women's Health, Fibroids and Liver Cancer: Embolization gets a new breather..marketwise speaking..Any other indications?

[Click on Post Title for Link to External Article]

Champagne bottles must be popping at BioSphere today. They have dipped into the Chinese market, thus proving what an advantage it could be for companies if they started selling in India or China.

They also saw an immediate spike on their stock price..

Moving on to Fibroid Embolization, I have always been curious about why this procedure did not take off more in the US. Of the 600,000 odd hysterectomies a year, about 40% are related to Fibroids directly or indirectly. That is about 240,000 procedures.

Comparitively speaking, there have been only a total of 50,000 (as of 2005) to about 75,000 (just my stretchy guess. don't quote me) UFE procedures worldwide!

I can probably think of a few good reasons:

* Would gynecologists be willing to place their patients in the hands of Interventional Radiologists?

* Gyn-Surgeons prefer to do hysterectomy, and there are some dubious studies that claim that hysterectomy is actually a good option. [Refer to the bottom of this post for an "interesting" example]

* Embolization of Uterine Fibroid Arteries has been around for about 10+ years now, and has festered in the absence of strong scientific publications or long term studies backing it. A few studies have taken place, but are by no means large enough to justify a shift in treatment standards.

* Embolization cannot be the best solution always, since fibroids occur in multiples usually and it is not possible to accurately pinpoint or embolize arteries feeding all fibroids.

* Arterial embolization requires, among other things, good visualization, and in cases where the Uterine Artery or one of its main branches has been harvested by the fibroid to vascularize, embolization cannot be an option.

Among my other worries, something I wish to find out is, what are the risks of the microspheres, bioresorbable or not, in terms of their ability to cause thrombus related cardiovascular problems elsewhere in the body? Though this is sparsely discussed, again, for the want of long term follow up, no statistical data is available.

Well anyway, it still seems like, outside the US, where the lines between the practice of Interventional Radiology and Gynecology may be thin, or owing to the fact that hysterectomies tend to be expensive, it is possible that the availability of microspheres could help increase the number of UFEs performed worldwide, thus allowing us to see some long term data emerge, painting a clear picture...

As to primary liver cancers and Embolization, a similar lack of data seems to be the basic problem, although very honestly, I have not spent a lot of time looking at the problem area. Comments are welcome!

----
The Dubious Hysterectomy Debate:

http://pub.ucsf.edu/newsservices/releases/200704091/

This study in particular makes me very uncomfortable.

We don't have effective therapies for fibroids or pelvic pain - reasons for which include the inability to accurately pinpoint etiology and origin of pain. There are several options for menorrhagia, the leading product being NovaSure.

This study claims that since people with fibroids, pelvic pain and (wrongfully so) abnormal (typically heavy) menstrual bleeding do not have many treatment options, and hence will undergo hysterectomies anyway - one should now consider undergoing a hysterectomy to avoid "years of pain".

This strategy is very dubious, and fails to account for emerging treatment strategies as they relate to menorrhagia and fibroids. I am not very clear on chronic pelvic pain, but I am hoping someone out there is trying something.

So, instead of shying away from hysterectomy and encouraging other treatment options, the study snidely suggests that women should just be offered hysterectomy as a preventive measure.

Somehow it is a very disconcerting point of view....




Add to Onlywire

Women's Health: Sterilization Devices' War Heats Up...slowly

[Click on Post Title for Link to External Article]

I have already blogged about Essure from Conceptus. I saw this interesting article about "Ovion", acquired by American Medical Systems that enlisted the various players in the female permanent sterilization market and I thought it presented an interesting fight to wait and watch.

[Note: For those who don't know, Conceptus and Ovion were in a "first right of refusal" tussle that also arose from a previous dispute on Intellectual Property. However, AMS did finally close the acquisition following court intervention. The details of the settlements reached at various stages are murky and complicated. That could become a blog of its own...]

Now, Ovion and Conceptus will compete alongside Cytyc (which acquired Adiana) and IUD (Intra Uterine Devices). Actually, but for the IUD angle, this story would be a little dull.

Now that I have laid out the confusing matrix of players, let's dig in.

Tubal Ligation is the current gold standard for women who would like permanent sterilization. As is usual in many women's health issues, this is far from an elegant solution, requiring a hospital stay and provides very few options for reversal.

Essure from Conceptus is the first-in-class player, approved since 2002, but has made very little headway in an upscale fight against tubal ligation. This is not surprising, as is mostly the case with first-in-class devices. But, now that people know it works, Cytyc and AMS are banking on their acquisitions across the board.

Essure uses a metal implant, while Adiana uses radiofrequency energy and a polymer matrix implant to achieve occlusion. Adiana does claim opportunities to continue enabling endometrial ablation following the procedure and also in-vitro fertilization if the person changes her mind later. Exactly what Ovion does..is not clear though.

To match their clinical performance to this point, Essure placement never resulted in pregnancies. Adiana did have one pregnancy directly related to the placement, as reported. Ovion - I have not been able to find anything beyond the fact that AMS suspended trials for about 4 months. The whys and hows are up for grabs, as of now...

Given this situation, it seems like no clear leader is about to emerge among the three. And throw in IUD placement in the midst, and more confusion ensues... IUDs are very simple devices, allowing for easy placement, and office procedure times of just a few minutes.

Compared to this, Essure, Adiana and Ovion require hysteroscopic or other equipment which may not be available with many OB/GYN practitioners, require training, are time consuming, require analgesics and/or anesthesia and most importantly, a follow - up exam for confirmation, leading up to which the woman has to continue contraceptive pills.

IUDs also provide the best and simplest opportunity for a woman who changes her mind suddenly. IUDs are very easy to remove and this procedure is also pain-free, effective and consumes very little time.

If you are still reading, I would say, none of the three players show much promise to be a run-away success. This does not mean they will not sell, it just means the field is wide open for another player to come in and knock their socks out...like Cytyc's NovaSure did to about 3 or 4 major players in the endometrial ablation market, also effectively changing the practice of menorrhagia treatment and management.

Personally, I believe IUDs may not survive the onslaught of higher reimbursements, and will also fall prey to creative marketing solutions for women's health problems, such as the marriage of J&J's Gynecare Thermachoice and Essure as a combined, one-off solution to two headaches - endometrial ablation and female sterilization.

So knowing what may be in store for a new player, will there be one?

- There better be one!

The Women's Health market is large and growing, and can provide a nice addition to the bottom line of any growing medical device company. Moreover, replacing barbaric procedures with novel solutions should get Doctors and Engineers excited!

Also, given how medical device companies are getting handed funds and are being acquired left, right and center(which is a good thing), I am sure there will be interest generated in this area! Well, more may not necessarily be merrier...but hey, look at the prospect: atleast we could simplify the pain of aging procedures such as tubal ligation!

Note 2: Here is a generic list of various permanent sterilization options for women:

http://www.arhp.org/healthcareproviders/onlinepublications/
healthandsexuality/permanentoptions/PermanentOptionforWomenintheUS.cfm









Add to Onlywire

Non-Surgical Sterilization: Essure gets a leg up from British Journal

[Click on Post Title for Link to External Article]

Conceptus's Essure might not be the most effective non - surgical sterilization, but it is definitely a successful first-in-line treatment strategy for minimally invasive alternatives to tubal ligation.

Here is a link to the British Journal Abstract from June 2007:

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1471-0528.2007.01351.x

It is interesting to note the 92% success rate, but I am a bit baffled by the 4 - 5 day recovery period. Additional constraints on the device include an independent indication for success from normal uteri and the procedure being performed in the non-secretory phase of the menstrual cycle.

Definitely, there seems to be more room for improvement in the market. These improvements can come from: increased success rates, usability on varying uterine anatomies, and a NovaSure type "cycle blindness" - referring to the fact that the device can be used at any stage of the menstrual cycle.

Eventually, the success of Essure and similar devices will depend on OB/GYN practice moving from the OR to the office setting...


Add to Onlywire

Endometriosis: Finally some ground-breaking with new research

[Click on Post Title for Link to External Article]

Endometriosis is a disease that affects quite a number of women. Although only about 25% of them express symptoms, they can range anywhere from pain to infertility.

Endometriosis is a condition where endometrial, or endometrial-like tissue lodges itself in parts of the Woman's body outside the uterus, and has been noted all the way up in the brain in rare cases!

There has always been a link between endometriosis and certain types of uterine and extra-uterine cancer. So there is no new news in that, however.

It is sombre to note that not much research has been performed, especially at the basic level to understand the etiology of the disease. Hence, it is heartening to see new developments.

I perceive the interesting results from this study open up the chances for a medical treatment both preceding and following some type of simple surgical procedure that excises endometrial tissue to alleviate pain. There is also the possibility that these agonists can be delivered in-situ through a delivery device based approach.

Add to Onlywire