A female received sculptra into hands to treat very thin hands.
Had 3/4 sessions.
States massaged hands 4 xs daily for 1 week after injections.
Experienced areas of clumping and a mass of balls in each hand.
In one hand the clumping was not even near where she was injected.
Reports the areas stick up and are very noticeable.
States her hands looked better before the sculptra.
Was told by her physician that it might take 2 years to go away.
Additional info ptc investigation results show that this kind of event is not batch related.
No faults, defects, damages detectable.
Conclusion: no faults detectable.
The consumer confirmed experienced pea size lumps, clumped together on her hands and that the event is ongoing.
Indicates the sculptra injections were given to her by a nurse and that no biopsy was taken.
Additional info from legal 01oct09: in 2007, consumer rec'd 1 bottle of sculptra on both hands.
Five months later, she received a half bottle (3 cc) of sculptra.
In 2008, received botox and a half bottle of sculptra.
One-quarter of the bottle of sculptra was injected into her right hand.
Received a half bottle of sculptra six months later.
She rec'd 1cc of sculptra in the thumb, index and right.
In 2009, the pt saw her physician and expressed concern regarding some bumps in her bilateral hands from sculptra injections.
Two months later, pt came to office for botulinum toxin type a treatment, and it was noted that the bumps were enlarged.
Additional info from consumer via legal on 13oct09: she reported that the sculptra had moved into a big ball at the top of her hand with a lot of lumps in it.
Sculptra was never injected there but she stated that it looked like a big knot on the top of her hand.
The other hand had lumps that were just in one area and separated.
Her right hand had a big ball with a few lumps that have shifted and were very noticeable.
It did not seem to be getting bigger as it had been over a year.
She also stated that she did not see any change.
Additional lot #s: a7017, exp date: 06/30/2009.
Explanted in 2008, lot# a5010, exp date: 11/30/2007, explanted in 2007.