Hyaluronic Acid Side Effects - Case Study
November 2, 2011
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Hyaluronic acid Quick View
Hyaluronic Acid is a polysaccharide composed of alternating molecules of N-acetyl glucosamine and D-glucuronic acid.
It can be found within collagen throughout the body. As the most important space filling substance in the human body.
Hyaluronic Acid holds water to keep collagen hydrated and "youthful". Hyaluronic Acid forms a viscous fluid with
exceptional lubricating properties necessary for the vital functions of many parts of the human body including the skin,
heart valves, aqueous/ vitreous humor of the eye and synovial fluid (joint lubricant). The skin contains over 50% of the
bodies Hyaluronic Acid. Considering that skin is over 70% water and renews itself more readily than most other bodily
tissues. Definitely hyaluronic Acid may have benefits on skin's structure and daily maintenance.
Selected Cases on Hyaluronic Acid Side Effects
The following section lists out only a few cases of hyaluronic acid side effects. There are many more cases about the
side effects of hyaluronic acid.

Event Date 03/13/2009
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

Red knee [erythema], hot knee [joint warmth], knee very swollen [joint swelling], knee effusion [joint effusion]. Case
description: a spontaneous report was received on (b)(6) 2009 from a healthcare provider (hcp) via a company rep
regarding a male pt with a history of osteoarthritis, initials (b)(6), who experienced knee redness, knee warmth, knee
swelling, and knee effusion after starting synvisc. The pt had a history of previous treatments with synvisc. He received
two injections of synvisc into his knee (laterality unspecified) on (b)(6) 2009. The hcp stated that at an unspecified time
after the pt's second injection of synvisc the injected knee became "red, hot and very swollen. " approx 80 cc of fluid
was aspirated from the injected knee (unspecified date). No other info was provided. At the time of this report, the
outcome of the pt was unk. Additional info was received on (b)(6) 2009 from a healthcare provider (hcp) who confirmed
the pt had a history of osteoarthritis for one year. He updated the medical history to include no prior effusions and no
previous treatment with nsaids, steroids, or viscosupplementation. The hcp confirmed the pt received two synvisc
injections in the left knee on (b)(6) 2009 with no effusion collected before the injections. He confirmed the pt
experienced left knee redness, hot knee, swollen knee and knee effusion and reported that the events were severe in
intensity. He commented that red knee, hot knee, and swollen knee were definitely related to synvisc, but did not
comment on the relationship of synvisc to knee effusion. The hcp reported that he aspirated 60cc of greenish tinged
fluid from the left knee (no laboratory report provided) and the pt was given 1cc of kenalog and 2cc of xylocaine. At the
time of this report ((b)(6) 2009) the pt had recovered. No lot number was provided.   

Event Date 06/01/2009
Event Type  Other   Patient Outcome  Other;
Event Description

On (b)(6) 2009, a spontaneous report was received from a nurse regarding a (b)(6) female who received an injection of
perlane (cross-linked hyaluronic acid dermal filler) and an injection of restylane (cross-linked hyaluronic acid dermal
filler). Medical history included previous cosmetic surgery including a face lift, facial peel, tummy tuck, breast reduction
and breast lift; the pt had no known medical conditions. Concomitant medications included armour thyroid (thyroid
tablets, usp) for an unknown duration. The pt received a 1 ml injection of perlane (1 syringe) and a 2 ml injection of
restylane (2 syringes) on (b)(6) 2009 to the nasolabial fold and the prejowl area. Pre-procedure medications included
unspecified general anesthesia. Additional procedures at the time of implantation included an arm lift and a facial peel.
On an unspecified date in (b)(6) 2009, soon after the procedure, the pt experienced an inability to move the right side
of her face well. On (b)(6) 2009, the pt visited the clinic for a second opinion. The result of the medical evaluation was
muscle weakness or paralysis to the right side of the pt's face. No treatment was provided. The lot number and
expiration date were reported as unknown. Additional info has been requested. The other suspect medical device
identified in this report, restylane, has been reported as mrn# 2032896-2009-00014 (case number (b)(4)).

Lot Number W1013
Event Date 02/11/2011

Redness [injection site erythema]. Swelling [injection site swelling]. Slight itching at injection sites only both eyes at
crows feet and mouth vertical perioral lines [injection site pruritus]. Tender, erythematous nodules [injection site
nodule]. Allergic reaction [hypersensitivity]. Burning [infection site pain]. Case description: spontaneous report received
on (b)(6) 2011 from a dermatologist regarding a female pt. Pt initials, age, and medical history were not provided. The
pt injected with prevelle silk. Date and location of the injection was not provided. The dermatologist stated that the pt
experienced an allergic reaction. At the time of this report, the outcome of the events and treatment were not provided.
The prevelle silk lot number was not provided. No further info was provided. Additional info received on (b)(6) 2011
from the dermatologist regarding the (b)(6) female caucasian pt initials (b)(6). The pt's medical history included radial
keratotomy in 1986, abdominal liposuction and mild depression in 1995, post menopausal in 2003, right eye ablation to
correct vision in 2007, and juvederm (cross-linked hyaluronic acid) to the lips in 1998. Prevelle silk treatment was
injected on (b)(6) 2011 for crow's feet and the lips for vertical perioral lines only. The onset of the allergic reaction was
(b)(6) 2011. The pt experienced redness, swelling, burning, slight itching at the injection sites which was around both
eyes at the crow's feet and the vertical perioral lines around the mouth. The events have not yet recovered. The
relation of the events to prevelle silk was definite. The severity of the symptom was moderate. Treatment included
allegra (fexofenadine) one tablet po (oral) qd (every day) started on (b)(6) 2011. The prevelle silk lot number was
w1013, expiration date aug 2012. No further info was provided.

Event Date 04/11/2008
Event Type  Injury   Patient Outcome  Hospitalization;
Event Description

In 2008, fidia received this report from expanscience, the marketing authorization holder for hyalgan. On the day
before, expanscience received the following info from another country's health authorities: three years ago, the female
pt, with an unk past medical history, was treated with 3 injections of hyalgan in the knee. On an unk date, the pt was
treated with hyalgan in the left shoulder, and she experienced eruption on left ear, erythema, oedema and pruritus.
Three months earlier, the pt received one injection of hyalgan 20mg/2ml (indication for use not provided) and on the
same evening she experienced serum sickness, urticaria, and fever to 39. 5 degrees celsius some days later. The pt
was hospitalized on six days later, for fever to 38. 7 degrees celsius and urticaria without mucous infringement; she
recovered with corticotherapy. No arthralgia. At the time of the reporting, the pt has recovered.

Event Date 05/01/2009
Event Type  No Answer Provided  

(b)(4). Initial report: this non-serious spontaneous case from (b)(6) was reported by a nurse via a company
representative and forwarded by our local affiliate (b)(4). Initial and follow-up info received on 16-jun and 29-jun-09
respectively were processed together. This case involves a (b)(6) female pt who received therapy with poly-l-lactic acid
(sculptra) as follows: on (b)(6) 2009: poly-l-lactic acid was diluted with 5 ml sterile water + 2. 5 ml lidocaine with 2 vials in
total injected to temple, cheek, and nasolabial. On (b)(6) 2009: poly-l-lactic acid was diluted with 5 ml sterile water + 2. 5
ml lidocaine with 1 vial in total injected to temple, cheek, nasolabial, and tear through. On (b)(6) 2009: poly-l-lactic acid
was diluted with 5 ml sterile water + 2. 5 ml lidocaine with 1 vial in total injected to cheek area. Concomitant treatments
included hyaluronic acid (hydrafill) to cheek area on (b)(6) 2009. The pt has no concomitant pathologies and no
additional medical history was provided. Concomitant medication info was not mentioned. Ten days after her third
treatment, the pt noticed swelling in the right eye bag area. The swelling was not infected or painful. This event
resolved two days later. The reporter stated that she thought it was unlikely to be treatment related. Two weeks later,
the pt complained that the eye bag area was now more noticeable since poly-l-lactic acid treatment. On examination of
the before and after photographs, the area remains the same. The noticeable bag area is persisting. No corrective
treatment was given. The causality assessment between the events and poly-l-lactic acid was reported as unrelated.

Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Required Intervention; Other

Initial information received from a customer on 05/10/2010: a (b)(6), female, received unknown dosage of poly-l-lactic
acid (sculptra, lot#, exp date unk) for cosmetic use in (b)(6) 2009. Consumer stated that she got poly-l-lactic acid 5-7
years ago for cosmetic purposes. It seemed to last about 3 years. She decided to get poly-l-lactic acid again. Her last
injection was in (b)(6) 2009. She stated she didn't get as good of results this time. She stated "when i had the injection,
a lump grew on the right side of my cheek/mouth". Her doctor recently injected some hyaluronic acid (juvederm) by the
surrounding areas of where poly-l-lactic acid was injected. Since getting the hyaluronic acid, the poly-l-lactic acid is
really sore and feels bigger. She stated her skin appears to have this bumpy texture, almost like the poly-l-lactic is
pulling the hyaluronic acid towards it. Her doctor gave her a steroid shot because her face got all inflamed from the
reaction of the poly-l-lactic acid and hyaluronic acid. She further stated that she now feels like her face is wasting, face
is stiff from the steroid shot. No further information reported.