Hello, pearlrivers-ga!
Thank you for your patience while I compiled an answer to your
question(s):) There was an overwhelming amount of material to sift
through. To be honest, it took a considerable amount of time to read
through it all and "understand it myself" before I could adequately
begin to organize it into an answer for you!
As I stated in my clarification, your original question involved
approximately twenty-one separate questions, not all of which I
believed could be answered due to the price and time constraints of
GA, and the potential absence of publicly available information. While
I did find plenty of information to answer most of your questions, I
cannot advise you on the legal obligations of Sanofi Aventis
concerning past injections of New-Fill prior to their distribution of
the product.
Dermik Laboratories, which took over the marketing of
Sculptra/New-Fill in 2002, currently advertises a toll-free number for
those experiencing side effects or problems with one of their products
(the number is posted in the answer below). While you might want to
call them, I don't know whether they will offer you any advice
concerning a procedure done before they were involved in the marketing
and distribution of Sculptra/NewFill.
Many of the references concerning injection of New-Fill/Sculptra
stress the importance of adequate training so that injections are
performed properly. As one doctor notes in an article referenced
below, "There is a high learning curve when working with
Sculptra....It is crucial that any and all papules or nodules are
smoothed out of the skin before the patient leaves your office."
http://www.findarticles.com/p/articles/mi_m0HMW/is_9_7/ai_n6235674
Some of the early U.S. practitioners received their training in
Europe. Dr. Gervais Frechette (NY) and Dr. Peter Engelhard (FL)
received their initial training from Dr. Elisabeth Laglenne of Biotech
Industries. (http://www.thebody.com/tpan/septoct_01/new_fill.html)
Since training is considered so important, I would suggest that you
address your concerns to the practitioner who provided your New-Fill
injection therapy. Nodules and lumpiness have been noted as a side
effect of injection therapy, and they have more potential to develop
when practitioner training is less than adequate. Of course, there is
no way to know (or prove) that the lumpy results you are currently
experiencing is due to poor initial training, or consequent sloppiness
on the part of the practitioner. I have included a Patient's Guide
insert for Sculptra in my answer. I do not know what was available as
an insert in the UK before Sanofi Aventis began to market
Sculptra/NewFill. Did your practitioner discuss potential side effects
with you?
As for your question pertaining to the use of "user experience for
commercial purposes in lieu of damages" - I cannot even begin to
advise you on that. I would be very leary of such an arrangement. My
best advice is to consult a local attorney!
I hope the information I have provided below helps you to become
better informed so that you can plead your case, if you so desire. I
could go on and on with this topic, since it is quite fascinating.
Unfortunately, I have spent far too many hours already and feel that I
must move on! However, if I can clarify anything further for you,
please let me know and I will try to help!
Sincerely,
umiat
========
SUMMARY
========
New-Fill/Sculptra is a product of Sanofi Aventis. New-Fill and
Sculptra are the same product marketed under different names. Sculptra
is the name used in the United States while New-Fill is the name used
for commercial sale of the product outside of the U.S. The generic
name is Poly-L-lactic acid (PLA). The New-Fill brand of PLA has been
approved since 1999 in the European Union by the licensing agency
G-Med as a medical device for the treatment of scars and in aesthetic
surgery. Dermik Laboratories, a Division of Aventis Pharmaceuticals,
Inc, acquired New-Fill in 2002. The U.S Food and Drug Administration
granted final approval for the use of Sculptra in the U.S for the
indication of HIV associated facial lipoatrophy on August 4, 2004.
Sculptra/New-Fill is intended to correct shape and contour
deficiencies resulting from facial fat loss associated with HIV.
However, New-Fill/Sculptra is also currently being used "off-label"
for general cosmetic purposes.
****************************
NEWFILL/SCULPTRA - OVERVIEW
****************************
A comprehensive overview of New-Fill/Sculptra is contained in the
references below. I have excerpted a few key points, but you should
read the articles in their entirety for a comprehensive understanding
of the approval and uses of New Fill and Sculptra.
=
Excerpts from Shore Laser:
"Poly-L-Lactic Acid (PLA), marketed in the U.S. as Sculptra®, and
worldwide as New-Fill® is a safe and effective treatment for facial
volume loss that has been used in 30 countries worldwide since 1999,
and was recently approved in the U.S for HIV associated lipodystrophy
(fat loss)."
"PLA is injected just under the skin, where the material stimulates
formation of new collagen over the course of 4-6 weeks, gradually
filling in hollows, indentations and skin creases to restore
youthful-appearing facial contours. The improvement typically lasts
from 2-4 years, and the procedure can be repeated as needed for
maintenance."
"Treatment with Sculptra is performed in the office with topical
anesthesia (see Using Topical Anesthetics), and although it is
considered a "no down-time" procedure, injection-related problems such
as bleeding, bruising, swelling, and redness can occur. A possible
side-effect of treatment is the occurence of small "bumps" under the
skin, more common under thin skin, and only rarely visible, although
they may be felt when the skin is pressed."
"Although loss of facial volume is a natural consequence of aging,
certain diseases, including HIV infection, are characterized by
excessive loss of facial fat (lipoatrophy) in younger patients. Volume
enhancement with PLA treatment is especially usefull in restoring
normal facial contours in these patients. Sculptra® is currently FDA
approved for this indication in the US, and may be used "off-label"
for cosmetic reasons in patients without HIV."
*** "New-Fill® was developed by Dr. Elisabeth LaGlenne at BioTech
Industry SA of Luxembourg, and was approved for aesthetic use in
Europe in 1999.
"Dr. LaGlenne at BioTech Industry is credited with the first use of
PLA in an HIV positive patient shortly before New-Fill's approval in
Europe in 1999, and Dr Paul Amard of Paris reported the results of a
26 patient pilot study at the 2d International Workshop on Adverse
Drug Reactions and Lipodsytrophy in Toronto in September 2000."
"Although New-Fill was not approved in the U.S., patients with certain
qualifying illnesses, including HIV infection, are allowed to import
drugs approved outside the US for the treatment of those illnesses
under the U.S. Food and Drug Administration' s (FDA) Personal Use
Guidelines, established in 1988 in response to political pressure from
HIV/AIDS activists groups. Patients in the U.S. with HIV related
lipodystrophy were allowed to import New-Fill directly or through a
buying club, the Direct Access Alternative Information Resources
(DAAIR), established in the early 1990's as an information source and
facilitating organization for patients with chronic illness, including
HIV, hepatitis, and diabetes."
"DAAIR begain importing New-Fill in the 2d quarter of 2001, and
distributing it to patients with a physician's prescription. However,
the FDA halted importation of New-Fill in October 2001, reclassifying
it as a device, rather than a drug, arguing that administration by a
physiscian was necessary for proper use of the product, and therefore
the Personal Use Guidelines for drugs did not apply. This action by
the FDA severely limited the availability of New-Fill in the US,
although a number of physicians experienced in it's use subsequently
applied for an Investigational Device Exemption (IDE), in which data
on a product's safety and use are collected and forwarded to the FDA
for evaluation-essentially a clinical trial."
"Based on the safety profile and clinical efficacy demonstrated in the
VEGA and C&W studies, Dr. Peter Engelhard, in Miami Beach and Dr. Doug
Mest, in Los Angeles, performed the Apex 002 and Blue Pacific studies,
respectively. Each study enrolled 99 patients with HIV-associated
facial lipoatrophy treated with PLA and followed up to 1 year.
Clinical efficacy was demonstrated by serial photography and skin
thickness measurments, with high patient satisfaction and safety. An
expedited Pre-Market Approval (PMA) appplication for Sculptra® was
granted because the device met a need which was not otherwise
addressed, and final approval for the indication of HIV associated
facial lipoatrophy was granted on August 4, 2004."
See "Poly-L-Lactic Acid for Facial Augmentation." Shore Laser.
http://www.shorelaser.com/PLAAugmentation.html
==
About New-Fill/Sculptra
"Sculptra ® (New-Fill®) was launched in the U.K. in the year 2000 and
the manufacturer claims that the product can help cause new collagen
growth rather than just mechanically filling depressions. This product
was rebranded under the new name Sculptra® in 2004 and is growing in
popularity in the U.K. and Europe.
Generic name - Poly-L-lactic acid
How is it made? - Synthetic polymer manufactured from lactic acid
Is a skin test required before treatment? - No.
Is it temporary or permanent? - Poly-L-lactic acid is completely
broken down within the skin over a period of months, however the
results (new collagen growth) can last for up to 2 years or longer.
Licenced status - Medical device.
** Should be used by Trained members of the medical profession only.
Product uses - Sculptra® can be used in deep depressions of the face
and for cheek augmentation as well as a sculpting agent for any area
of the face.
From "NewFill / Sculptra."
http://www.consultingroom.com/Aesthetics/Products/Product_Display.asp?ID=100
==
*** IMPORTANT - This insert is available for all patients before
treatment. Your practitioner should have shared it with you
Insert: "A patients guide to treatment with Sculptra."
http://www1.sculptra.com/US/resources/SculptraPatientGuide.pdf
==========================================
History of Licensing of NewFill in the UK
==========================================
"This product is a synthetic polymer that has been approved since 1999
in the European Union by the licensing agency G-Med as a medical
device for the treatment of scars and in aesthetic surgery."
See "NEWFILL for Lipoatrophy." 8th European Conference on Clinical
Aspects and treatment of HIV-Infection (ECCATHI) Athens, Greece -
October 2001." http://www.natap.org/2001/8thEccathi/day7.htm
==
"Original Approval of New-Fill was for the esthetical correction of
scars and wrinkles:
Newfill® is an hydrogel of poly-L-lactic acid (PLA) developped by
Biotech Industry SA.
* PLA is a synthetic polymer, totally biodegradable, immunologically inert.
* PLA is used in different reconstructive surgeries.
* Sterile dry powder of 0.15 g of PLA (1 vial of Newfill® ) + 4ml of water.
* Newfill® has been approved by the G-MED (European Authorities for the
Medical Devices) in 11/99 in esthetical corrections of scars and wrinkles.
From "Polylactic acid implants (New-Fill.) in the correction of facial
lipoatrophy in HIV-infected patients (VEGA study) : results at weeks.
http://www.new-fill.info/DE/download/studien/w_studie.pdf
==
"According to Biotech Industry S.A., the company in Luxembourg that
markets the New-Fill brand of polylactic acid, PLA is a nontoxic
synthetic compound that is immunologically inactive (having no effect
on the immune system) and easily absorbed within the body. PLA has
been used safely for over forty years in reconstructive surgery (e.g.,
of the head and neck), as an ingredient in surgical sutures, and as a
vector for sustained release of medication. In November 1999 the
New-Fill brand of PLA was approved in Europe for aesthetic correction
of scars and wrinkles by G-MED, the authority that assesses and
approves medical devices in the European Union."
From "New Fill To Treat Facial Wasting," by Nicholas Cheonis. Bulletin
of Experimental Treatments for AIDS, Spring 2002.
http://www.aegis.com/pubs/beta/2002/BE020301.html
===============================
U.S - FDA Approval of Sculptra
===============================
"After an expedited review, the Food and Drug Administration (FDA)
today approved an injectable filler to correct facial fat loss in
people with human immunodeficiency virus (HIV) infection."
"Sculptra should only be used in patients with HIV by health care
providers who are fully familiar with the product training materials
provided by Dermik and the entire product package insert. The use of
the product for other indications, such as to treat wrinkles, has not
been approved by FDA."
"As a condition of approval, Dermik has agreed to conduct an
open-label registry study of 100 patients for five years to evaluate
Sculptra?s long-term safety. The study will include at least 30
females and 30 people with dark skin types."
From "FDA Approves Sculptra for HIV Patients." U.S. Food and Drug
Admininstration Press Release. August 3, 2004.
http://www.fda.gov/bbs/topics/news/2004/NEW01100.html
=============
Manufacturer
=============
Sculptra is manufactured by the French company Aventis and marketed by
Dermik Laboratories, "the U.S. dermatology arm of Aventis."
http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.jsp?id=124887
==
See a chart concerning the "History of Sculptra" by Dermik Aethetics.
http://66.102.7.104/search?q=cache:iUDry8vyUUIJ:www1.sculptra.com/US/hcp/Index.jsp+nodules+from+Sculptra&hl=en
=============================================================
SCULPTRA IS ALSO BEING USED OFF-LABEL FOR AESTHETIC PURPOSES
=============================================================
"Some physicians are now using Sculptra on an off-label basis for
cosmetic purposes in non-HIV patients (the filler has not been
approved for this purpose yet). The treatment appears to be safe and
can last for two or more years."
From "Soft Tissue Fillers - Treatment of lines and wrinkles."
http://www.wowt.com/news/features/2/1492297.html
==
"Sculptra is only FDA approved for fat loss secondary to HIV illness.
That does not mean you will get HIV if you use it! It means that if
you are going to have Sculptra used on you, your physician is using it
"off label," which is legal. Botox was and is still used "off label"
as it is only FDA approved for the furrows between your eyes.
From "Filling you in on Sculptra." Miami Herald - May 31, 2005
http://www.aegis.com/news/mh/2005/MH050510.html
==
"Although it was originally developed to treat facial wasting in AIDS
patients, dermatologists have recently discovered that injecting
Sculptra into the face is a powerful anti-aging tool - so powerful,
it's been dubbed the liquid facelift."
"In the past, we have treated the fat loss, the lines around the
mouth, the jowls, with a facelift, by excising that excess saggy
skin," Karcher says. "The problem is, many people ended up just
looking tighter. Not more youthful. Sculptra is a more natural
process. We put back what was lost. If a patient has a Sculptra
treatment, we can shave 10 years off the way they look."
From "Searching For Fountain Of Youth." CBS News. NEW YORK, Sept. 26, 2005
http://www.cbsnews.com/stories/2005/09/26/earlyshow/living/main883632.shtml
========================================
INJECTIONS IN AREAS OTHER THAN THE FACE
========================================
Though I have seen no product literature recommending Sculptra for
injection in an area other than the face, I have found several clinics
that "currently" advertise it's use in other areas of the body
(including the hands!) Again, I did NOT find any record of this usage
in early New-Fill brochures or Sculptra product brochures.
"Sculptra is exceptionally effective in 'filling in' cutaneous
wrinkles and furrows. It makes the skin appear smoother and firmer,
enabling it to regain its previous elasticity. Sculptra achieves
excellent results in treating all parts of the face including the
forehead, around the eyes and lips, between the mouth and nose, and
the cheeks. It adds volume to the cheeks and lips, to folds around the
chin, and to hollow or 'baggy' rings around the eyes. It is equally
effective on the neck and décolletage (lower neckline), and even on
the hands, knees and ankles. Certain types of scars can also be
treated."
From "Sculptra." Boston Clinic (UK) Ltd
http://www.boston-clinic.co.uk/treatments/newfill/newfill.html
==
How can New-Fill be used?
"New-Fill© is an excellent way of treating lines and wrinkles on all
parts on the face including the forehead, around the eyes, lips and
between the mouth, nose and cheeks. It is also effective on the neck.
New-Fill© adds volumes to areas, which may have become hollow or baggy
such as around the eyes, cheeks, lips, folds around the chin and even
on the hands, knees and ankles. Certain types of scars can also be
treated."
See Treatments.
http://www.lifestyleclinic.co.uk/treatments/new_fill/
==
"Dr. Engelhard is one of very few is one of very few U.S. doctors with
extensive experience in the use of Sculptra (marketed overseas for
general cosmetic use as "New-Fill")." Dr. Engelhard trained in Europe.
"In Europe it's used for reconstruction of the cheek fat pad and for
filling deeper nasolabial folds," he says. But, he adds, "EU doctors
are using it almost everywhere - tightening the neck and even the skin
on the back of hands."
From "Sculptra: A wider future in the US?" by Rebecca Bryant.
Dermatology Times. 9/1/2004
http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.jsp?id=124887
==
"Though not yet approved for cosmetic use, physicians can use
Sculptratm "off-label" for filling lines and wrinkles. In a release
by The American Society for Aesthetic Plastic Surgery (ASAPS),
president Peter B. Fodor stated that "for cosmetic patients, the
benefits of Sculptratm in achieving long-lasting restoration of facial
volume have yet to be confirmed by clinical trials in the U.S.
However, the product is approved in Europe, where physicians have been
using it as a wrinkle-filler for five years with reportedly good
results."
See "Sculptra Injection Basics."
http://www.locateadoc.com/articles.cfm/1932/1266
=======================
POTENTIAL SIDE EFFECTS
=======================
Reported side effects - Few reported side effects include nodule
formation after injection. This is caused by too much product being
injected too superficially in the skin. Typically resolution is
spontaneous, over a period of months. Nodules can be treated if
required. Localised reactions thought to be of a hypersensitivity
nature have never been reported. Redness, tenderness and bruising may
occur at the time of injection but this resolves quickly.
From "NewFill / Sculptra."
http://www.consultingroom.com/Aesthetics/Products/Product_Display.asp?ID=100
==
"Along with its desired effects, PLLA can cause some unwanted effects;
not all of these effects are known at this time. Serious side effects
have been rare and include lightheadedness and faintness, swelling of
nodules developed under the skin, temporary numbing of the face, and
severe allergic reaction."
"Less serious side effects include redness, swelling, and bruising in
the area of the injection. Many patients have developed small nodules
in the skin where PLLA was injected. The nodules are not visible and
do not hurt."
From "Poly-L-lactic acid." (Non-technical version) Aids Info.
http://aidsinfo.nih.gov/drugs/htmldrug_nt.asp?int_id=0403
==
From the Technical Version information on the same product:
"PLLA was approved in 1999 in Europe, under the brand name New-Fill,
for the cosmetic treatment of wrinkles and has been used by an
estimated 100,000 people. Dermik Laboratories, the Pennsylvania-based
division of Aventis Pharmaceuticals Inc., filed with the FDA for
premarket approval of PLLA in the United States under the brand name
Sculptra. On March 25, 2004, the FDA's General and Plastic Surgery
Devices Advisory Panel recommended conditional approval for Sculptra
for the treatment of HIV-associated lipoatrophy.
*** Conditions for use in the U.S. include a physician training program,
Adverse Events/Toxicity:
"PLLA injection has been associated with some adverse effects. In 5
clinical studies of HIV infected patients, no major adverse events
were reported. Mild to moderate adverse events included bruising and
hematoma related to injection.
** The most common device-related adverse event was delayed occurrence
of subcutaneous papules, which were confined to the injection site and
were typically palpable, asymptomatic, and non-visible.
"Side effects reported at the March 25, 2004 meeting of the FDA's
General and Plastic Surgery Devices Advisory Panel included
discomfort, bruising, edema, hematoma, inflammation, and erythema at
the injection site."
"Post-injection, all patients had some degree of edema. A large
proportion of patients (77%) experienced pain during the injection
procedure, with about 28% of these requiring pain medication. About
13% of patients had post-injection non-inflammatory nodules or
papules. Severe side effects observed in limited clinical trials of
PLLA included vagal hypertonia and lightheadedness (7.5%),
inflammatory nodule development (1%), facial palsy upon hitting the
facial nerve during treatment (1%), and anaphylaxis (1%)."
From "Poly-L-lactic acid." (Technical Version) Aids Info.
http://aidsinfo.nih.gov/drugs/htmldrug_tech.asp?int_id=0403
==
"Complications and risks with Sculptra® treatment are rare. Whenever
the skin is injected, there is a risk of bleeding, sorness, and
bruising. Poly-L-Lactic Acid has been used for over 30 years as
absorbable sutures and implants, with an outstanding safety record,
and allergic reactions are extremely rare."
"The most common complication of PLA treatment is the occurence of
nodules in or below the skin. The 2 original studies reviewed for FDA
approval with Sculptra® /New-Fill® were performed in HIV patients
using a strong solution of the microcrystals, and in these patients
the incidence of palpable nodules was in the range of 50%, with NO
visible nodules. Another study performed for cosmetic reasons in
non-HIV patients with a weaker dilution and a different injection
technique demonstrated an incidence of palpable nodules of less than
1%. Using this weaker dilution and proper injection technique, we have
observed NO palpable or visible nodules in our patients to date."
See "Poly-L-Lactic Acid for Facial Augmentation." Shore Laser.
http://www.shorelaser.com/PLAAugmentation.html
==
"Sculptra's record is not unblemished, says San Antonio-based plastic
surgeon Tolbert Wilkinson, M.D., F.A.C.S., a member of the Emerging
Trends committee of the American Society for Aesthetic Plastic
Surgery. "We are getting reports from Europe about a good number of
people getting abscessed granulomas. Some are taking up to a year to
develop.
"It's the fillers that are supposed to last longer that tend to cause
the problems," he adds. In addition to granulomas (abscessed and
non-abscessed), other potential side effects include swelling,
redness, bruising and lumpiness."
"As with other fillers, Dr. Engelhard warns dermatologists to be
careful about applying in the periorbital area. "You have to inject
under the orbicularis muscle and in tiny amounts to avoid producing
nodules that might be visible," he says. Doctors should prepare the
polylactic crystals in sterile water a full two hours before use;
otherwise, needles tend to clog. To get a head start, doctors can prep
the night before, because Sculptra has a three-day shelf life without
refrigeration."
From "Sculptra: A wider future in the US?" by Rebecca Bryant.
Dermatology Times. 9/1/2004
http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.jsp?id=124887
==
Post injection massage can minimize subcutaneous nodules:
Fifteen patients developed minimal ecchymosis, which resolved
spontaneously within 2-3 days. 22 patients reported palpable (but
non-visible) subcutaneous micronodules that resolved in six patients
by week 96.
[Note: Further clinical experience suggests that this risk is
minimised by intense post-injection massage, and that this is
essential element of care].
From "Polylactic acid (New-Fill) repairs facial wasting and improves
quality of life. "Simon Collins, HIV i-Base. HIV Treatment Bulletin
Vol 4 No 10 December / January 2003 / 2004.
http://www.i-base.info/pub/htb/v4/htb4-10/Polylactic.html
==
"Several members of the review panel were concerned that the mechanism
of action of PLLA has not been identified, and by formation of what
was varyingly described as micro-nodules or irregularities. The
clinicians reported that these formations seldom were visible or even
noticed by the patients and often were discerned by the physician only
through palpation of the injected region.
Dr. Mest said the nodules tend to occur within the first two months of
treatment and slowly abate over time; he assumes they are excess
product. This points to a technique different from collagen in that
one initially should administer less of the PLLA and later add more as
needed.
"FDA panel recommends approval of Sculptra for treating HIV-related
facial lipoatrophy," by Bob Roehr. Cosmetic Surgery Times, May, 2004
http://www.findarticles.com/p/articles/mi_m0HMW/is_4_7/ai_n6018706
==
Lumpiness after injection is addressed in the following message:
Question:
"I had new fill done at my hospital in london, it finished 6 months
ago, It worked in as far as it plumped the face. It is quite uneven
and I am left with some pimple like lumps, one is 7mm. The hospital
has said they will refer me to a specialist, but it has been nearly 2
years since i was put on the waiting list for new fill and don't want
to wait another summer. I am very pleased with my health care in
general and don't want to 'fall out' over this. Where do i start to
find someone to correct this in london? Is it realistic that I pay for
this correction myself?"
Response from Graeme Moyle, MD.:
"Most of the UK, most of Europe, most of the US and all the developing
world has no NewFill service, let alone a free provision as provided
by a small number of UK clinics. The waiting list at those UK clinics
that do have a service is growing by the day with individuals who have
never accessed NewFill so the chances of a 'top-up' in the near future
are low. There are several private NewFill services in
London...contact Medifill in W8 for details or see adverts in Positive
nation etc. Lumpiness after newfill is uncommon but further treatments
and plently of massage should help this improve."
From "New fill correction." Apr 15, 2004
http://www.thebody.com/Forums/AIDS/Lipodystrophy/Archive/Facial/Q156180.html
============================================
Importance of Proper Training for Injection
=============================================
"The crucial factor in getting back the face you want is the use of
the proper dosage and the proper injection technique. Even for a very
good physician who is experienced in doing other types of facial
injections, the product is very difficult to use. The thickness makes
it tricky to inject and there are multiple sites to be filled (the
bucal fat pads, the temples, the perizygomatic and preauricular areas)
to give back a normal more youthful contour. It is important for
physicians (cosmetic surgeons, dermatologists) receive appropriate
training in how to inject the smallest quantity for the best result in
each area."
** "When placed too superficially, transient nodules can occur. This
is very rare but again this is technique dependent. It is extremely
important that the physician be well trained in the use of Sculptra."
From "Sculptra." Blue Pacific Aesthetic Group
http://bpacific.com/pages/sculptra.html
==
"Doctors should anticipate a high learning curve as they begin to
treat patients with the injectable filler Sculptra (Dermik
Laboratories, Berwyn, Pa.), once known as New-Fill, expected to be
made commercially available this month for treating facial lipoatrophy
associated with human immunodeficiency virus (HIV).
"There is a high learning curve when working with Sculptra," says Dr.
Burgess. "In other words, it is not the easiest filler substance to
inject for dermal enhancement." If the preparation is improperly
mixed, the particulate PLA can clog the needle, making it difficult to
administer the hydrogel," she says. "As a result, the viscosity of
Sculptra was unlike any other filler substance I had worked with."
Now, with the filler's approval, Dr. Burgess can obtain Sculptra and
pre-mix the preparation overnight, giving her better control over the
mixture. But doctors who haven't yet worked with Sculptra can expect a
similar experience until they acquaint themselves with the filler's
properties, she says."
***
To get the best results, Dr. Burgess says, she injects in a lattice
formation in the subcutaneous-dermal plane. But the procedure does not
end there. Some side effects reported with Sculptra include the
formation of papules and nodules at the injection site. Dr. Burgess
underscores how important post-injection molding is in preventing
those lumps and bumps."
"It is crucial that any and all papules or nodules are smoothed out of
the skin before the patient leaves your office," she says.
**
From "Doctors should expect high learning curve with Sculptra: surgeon
offers tips for using newly approved filler to treat facial
lipoatrophy in patients with HIV," by Melissa Heltzel. Cosmetic
Surgery Times, Oct, 2004.
http://www.findarticles.com/p/articles/mi_m0HMW/is_9_7/ai_n6235674
===
"PLA must be injected with a needle by a clinician trained
specifically in treating HIV-related facial wasting. Elisabeth
Laglenne, MD, general manager of Biotech Industry, was among the first
to try using PLA to restore facial fat loss in people with HIV. "The
indication for lipoatrophy was fortuitous," says Dr. Laglenne. "I
treated a friend-my first patient-for lipoatrophy in September 1999
and, after five sessions [spaced 15 days apart], his face was again
quite normal." Patrick Amard, MD, a maxillofacial surgeon based in
Paris, presented the first preliminary studies of PLA for wasting (see
below). While both claim to have originated the procedure for facial
lipoatrophy, the two physicians (along with Thierry Saint-Marc, MD, of
Lyons, France) clearly were in the vanguard with this unique use of
PLA and both have trained other clinicians in the technique. Dr. Amard
cautions that without special training, even clinicians familiar with
other injectable implants are likely to achieve disappointing results
with PLA."
"New-Fill is classified as a device because of the way it is intended
to be used, and the way it works. Devices include products, including
implants, that are intended to affect the structure or function of the
body, and do not achieve their intended purposes through chemical
action within or on the body, and which are not dependent upon being
metabolized to achieve their primary intended purposes. New-Fill has
not, to our knowledge, been studied for this indication in Europe, and
the clinical trial data for the current indication of filling small
lines, wrinkles, and skin depressions have not been submitted to the
FDA."
"The FDA further commented that "since this product needs to be
injected by a trained physician, it does not fall within the personal
use guidelines."
From "New Fill To Treat Facial Wasting," by Nicholas Cheonis. Bulletin
of Experimental Treatments for AIDS, Spring 2002.
http://www.aegis.com/pubs/beta/2002/BE020301.html
==
"Sculptra should only be used in patients with HIV by health care
providers who are fully familiar with the product training materials
provided by Dermik and the entire product package insert."
From "FDA Approves Sculptra for HIV Patients." 2004
http://www.fda.gov/bbs/topics/news/2004/NEW01100.html
==
"Only a health care provider with special training should inject PLLA."
From "Poly-L-lactic acid." (Non-technical version) Aids Info.
http://aidsinfo.nih.gov/drugs/htmldrug_nt.asp?int_id=0403
==
Advocacy Issues:
2) DOCTOR TRAINING. "The qualifications and training of the doctors
implementing Newfill procedures appear to be crucial to safety and
efficacy. Aventis/Dermik could be approached directly for negotiations
on implementing a standard for quality of care and training; and
perhaps an FDA monitored training program for doctors."
From "Report 2 on Sculptra (Newfill): FDA study review; advocacy
issues." HIV Articles
http://www.natap.org/2004/HIV/032904_02.htm
===========================================
Difficulty in obtaining New-Fill in the UK
===========================================
"Currently, being able to access New-Fill (polylactic acid) in the UK
for HIV-related facial lipoatrophy is akin to winning the lottery.
Only eight treatment centres in five English cities currently offer
New-Fill to their HIV patients - and many of those have extremely long
waiting lists. If you don?t attend a clinic north of the Thames in
London, or have not already been attending HIV clinics in Brighton,
Birmingham, Manchester or Portsmouth for at least a year, you are
unlikely to be able to get the NHS to treat your facial lipoatrophy,
as it has already for around 500 fortunate HIV patients.
"However, cogs are whirring amongst the powers that be that will
hopefully change the current postcode lottery situation and may soon
make the availability of New-Fill equitable, first throughout London,
and then hopefully throughout England, and possibly in Wales and
Scotland (which have their own HIV strategies). But, as Professor
Brian Gazzard - Chair of the London HIV Consortium Advisory Group
Drugs Sub-committee - points out, wearily: "There is a willingness to
do it; it is the practicality of getting it done that is very
difficult."
Patent and Distribution:
"The patent for New-Fill is owned worldwide by the drug company
Aventis, although the UK?s sole distributor is an organisation called
MediPhill, who have a private clinic on Harley Street in London, and
have treated more than 300 people with HIV-related lipoatrophy in the
past two years. However, Dr. Barton and many others working in the
field feel very strongly that New-Fill should be made available on the
NHS to everyone with significant HIV-related facial wasting who is
distressed by it."
Read further..."Why accessing the facial wasting treatment is
currently a postcode lottery, by Edwin J Bernard. Updated August 25,
2004
http://www.aidsmap.com/en/docs/1445B54B-C33F-42C7-BED8-922E76D9FE6C.asp
==
Access to polylactic acid (New Fill):
"Access to treatments that can repair facial fat loss is limited -
currently, only a few hundred patients are receiving New Fill
treatment in the UK, largely through hospitals in London, Brighton and
Manchester. However, demand for private treatment is such that New
Fill?s distributor is employing a nurse two days a week to carry out
treatment for people with facial fat loss who have decided to go
private - at a cost of around £400 a session."
"Is there any possibility that New Fill treatment will become more
widely available soon? The London HIV Consortium HIV Drugs Committee
is likely to recommend that New Fill treatment should be provided to
all patients in London who need it, but it may not be available at
every centre due to the need for staff to be trained and space to be
set aside in the clinic to carry out the procedure. Instead, it is
likely that patients will be referred to centres within the service
network (a group of hospitals that work together to provide HIV
care)."
Private treatment:
"New Fill is obtainable in the UK through MediPhill (020 7937 2377) at
approximately £1200 for four sessions. It is currently administered
through MediPhill?s nurse practitioner, or through a Harley Street
clinic experienced in providing the treatment for patients with
lipoatrophy (which is much more expensive)."
See "Treating facial wasting." Last updated: 30.10.05
http://www.aidsmap.com/en/docs/DB528ADF-9124-4559-A4FB-AE8EE514647A.asp
=======================
SCULPTRA MESSAGE BOARD
=======================
In case you are interested in the experiences of others, see the
message board on the Make Me Heal website:
http://www.makemeheal.com/forum/viewThread.jsp?forum=24&thread=40523
http://www.makemeheal.com/forum/viewForum.jsp?forum=24&start=100&range=100
=============================================
ABOUT SANOFI AVENTIS AND DERMIK LABORATORIES
=============================================
The following link should tell you everying you want to know about the
Sanofi Aventis company!
http://en.sanofi-aventis.com/index.asp
==
From the Dermik Website:
"Dermik Laboratories conducts the North American business of
sanofi-aventis Dermatology, the global dermatology unit of
sanofi-aventis. Dermik has nearly 60 years of experience in the
development, marketing, and distribution of innovative prescription
pharmaceutical products. Dermik has created a new division, Dermik
Aesthetics, that will focus on marketing innovative, enduring, and
reliable treatments to improve appearance and well-being. Dermik's
mission is to foster healthy-looking skin and in turn, a healthy
outlook for life.
About sanofi-aventis:
The sanofi-aventis Group is the world's third largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular disease, thrombosis, oncology,
diabetes, central nervous system, internal medicine, and vaccines. The
sanofi-aventis Group conducts business in the U.S. through its
subsidiaries Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc., and
Sanofi Pasteur Inc. The sanofi-aventis Group is listed in Paris
(EURONEXT : SAN) and in New York (NYSE : SNY).
See http://www.dermik.com/about/Index.jsp
Report a Problem:
If you are experiencing a side effect or problem with a Dermik
product, please contact Medical Information Services at
1-800-633-1610.
http://www.dermik.com/products/Index.jsp?range=a
=======================
ADDITIONAL INFORMATION
=======================
"New cosmetic procedure combats facial side effects of HIV meds," by
Rhonda Smith. Washington Blade - October 25, 2002.
http://www.aegis.com/news/wb/2002/WB021008.html
Report 2 on Sculptra (Newfill): FDA study review; advocacy issues."
Reported by Jules Levin. http://www.natap.org/2004/HIV/032904_02.htm
For a lengthy presentation on Sculptra, see "Food and Drug
Administration - General and Plastic Surgery Devices Panel." March 25,
2004 - Slides
http://www.fda.gov/ohrms/dockets/ac/04/slides/4031s1.htm
Sculptra - P030050, Dr. Herbert Lerner, MD (HTM) (PPT)
Sculptra (Injectable poly-L-lactic acid), Dr. Kimberley Forbes-McKean, PhD,
Dermik Laboratories (HTM) (PPT)
===
Again - I hope this is helpful! Good luck for the future!
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