No more "boob-jab" - Macrolane withdrawn from breast augmentation in UK

For the past 5 years, there was an injectable filler called Macrolane that was being used in the UK for all sorts of body contouring operations - including breast augmentation.  As you might imagine, the idea of a "lunchtime" breast augmentation by injection - in 45 minutes without the need for implants - became quite popular in the U.K.

However, there were significant problems with breast hardness and lumpiness after the treatment. Rather than behaving like a typical soft tissue filler like we might use in the lips or in a facial wrinkle, large deposits of Macrolane seemed to behave more like an actual implant, with potential for capsular contracture formation, and potential for hardness or tissue distortion.

According to the Daily Mail newspaper, the manufacturers of the product (Q-Med of Sweden) have now decided to withdraw it from use in the breast, due to concerns that it would make mammograms more difficult to read or make a cancer more difficult to detect.

A spokesman for the British equivalent of the FDA, known as the Medicines and Healthcare products Regulatory Agency (MHRA) said: "This is not because of safety concerns with the product itself but because the product may interfere with the reading of mammograms and could make diagnosis more difficult. The product can still be used in its other indications, such as augmenting body contour and correcting soft tissue defects."

The British Association of Aesthetic Plastic Surgeons (BAAPS) said that in a survey of its members, 25% of surgeons reported patient complications after the use of Macrolane.

Macrolane, a thicker cousin of Restylane, is not yet available in the U.S. for any application.

Botox, Dysport and now...Xeomin

Just this week, the FDA has approved another competitor for Botox. This one is called Xeomin, and it's sold by Merz Aesthetics.

Just like Botox and Dysport, it temporarily reduces wrinkle lines, such as the frown lines between the eyebrows. However, Xeomin does not require refrigeration prior to reconstitution and mixing. According to the manufacturer's press release, Xeomin will be available in the spring of 2012.

One of the subtle differences between these 3 products is that Xeomin has a lower "protein load" than either Botox or Dysport. This might be helpful for the rare person that has developed antibodies to either Botox or Dysport.

Also, unlike Dysport, the dosages used are the same as Botox® Cosmetic - so direct comparison of the treatment effect is much easier.

So the big question: will more competition bring the wholesale price of the product down? While that would be nice, I'm skeptical that it will happen. Time will tell.

NYC Woman Dies after Silicone Injection

Injection of liquid silicone - used for soft tissue augmentation - has a long and very controversial history. Liquid Silicone is not FDA approved for cosmetic indications, like plumping up wrinkles, lips or other body parts, but is approved for the treatment of retinal detachments by ophthalmologists. The legality of cosmetic silicone injections is, to say the least, complicated.

Underground "pump parties" by unlicensed non-medical personnel go on, especially in South Florida - as people seem to want a permanent soft-tissue filler, despite the long-term potential side effects. Often the products injected are of dubious purity, and are designed for industrial applications, rather than being medical-grade purity.

Well-known side effects of silicone injections include:
- migration of the injected material
- chronic inflammation with swelling, redness and tenderness
- granuloma formation
- extrusion of the material
- scar tissue formation with possible distortion of adjacent soft tissue
- pulmonary embolism and pneumonitis (potentially life threatening lung issues)

Every year, there are several reports of deaths following liquid silicone injections, typically by unlicensed personnel. Another one happened this week in NYC. Here's the link to the story. The article says that a silicone-related pulmonary embolism was determined to be the cause of death.

Frequent readers of PSB - the Plastic Surgery Blog will be able to name a number of obvious problems with this lady's injection: Non-FDA approved material injected in large quantities, by an unlicensed practitioner, in a non-medical setting. This death was needless, tragic, and entirely preventable.

Bottom line: Get your injectables from a reputable, experienced physician in a medical environment. Use only FDA-approved injectable products. I do not recommend liquid silicone for soft tissue augmentation. More information on safe, FDA-approved products for soft tissue augmentation can be found at www.injectablesafety.org.