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

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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









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