Hello rzw,
When I started researching your question, I found only information
about Panacryl sutures; hence I began to suspect that they were the
ones with the problem. I asked for the clarification before I
attempted further research. I have since found information on Vicryl
sutures for you. (I've included the information I had found on
Panacryl sutures for reference)
?It's a heartbreaking story of people plagued with nasty infections.
Infections they say, they had no business getting. It started with a
tip from a local woman, then we found several others with similar
claims. Heather Tabb says this relentless infection started days after
a March 2002 surgery to remove a non-cancerous lump from her breast.
Her doctor sealed her incision with vicryl, dissolvable sutures made
by Ethicon, a Johnson and Johnson company. The infection worsened and
she had to have part of her breast removed. She and her lawyer blame
Ethicon.
According to the FDA in 1994, the company issued a voluntary recall of
about 3.5 million vicryl sutures for sterilization problems. Shortly
after, there were two other voluntary recalls by medical distributors
and an ongoing one was issued in 1998. Then in 2001, Ethicon issued a
voluntary recall, marked urgent. It said that some sutures in 247 lots
of synthetic absorbable sutures may not have been sterile due to a
package defect. Ethicon says lots can hold anywhere from 100 to 14,000
sutures. A spokesperson for Tabb's doctor says there's unlikely a
connection between the infection and the sutures because Tabb's
non-cancerous lump was an existing infection.?
http://abclocal.go.com/wtvg/features/iteam/1229medicalmistake.html
?In 1994, Ethicon had a new sterilizer they used to manufacture and
sterilize these sutures. They had a problem, and they didn't tell
anybody about it. The FDA, which regulates these companies, received
an anonymous phone call stating that there was a problem at the
Ethicon plant with these vicryl sutures, that there was a problem with
contaminated sutures being sent out to the medical community.
Q: What did the FDA do?
A: The FDA did a surprise inspection. They went out to the San Angelo
facility, spending almost a week there. They found all kinds of
problems and deviations from the manufacturing practices. The FDA sent
Ethicon a warning letter in August of 1994 and said: Look, you have a
problem. You didn't do anything about it. You deviated from good
manufacturing practices and, if you don't address the issue
immediately, we will prevent you from getting any additional FDA
market approvals for any of your other products, as well as prevent
you from selling to the U.S. government or contracting with the
government.
Q: Wait a minute. So this outfit was manufacturing these surgical
sutures, and they knew they weren't sterilized?
A: Right.
Q: And they allowed them to be distributed? That's criminal, isn't it?
A: Yes, it's criminal. Well, no, I can't say it's criminal.?
http://www.geoffmetcalf.com/qa/21831.html
?Seals on some inner packages were destroyed during resterilizing,
exposing the absorbable sutures to humidity different than provided in
the original packaging. The primary mechanism for degradation of the
tested sutures is hydrolysis.4 Loss of seal integrity might not cause
an initial strength loss, as was observed in two of the tested suture
types; however, for all absorbable sutures with the inner seal
destroyed during repackaging, exposure to increased humidity for an
extended time will cause suture degradation. This leads to a loss of
strength after shelf aging and a loss of strength and possible changes
in the degradation behavior after clinical use. These changes in the
suture material could result in wound dehiscence or other
complications.?
http://www.ssmonline.org/News/ViewRelease.asp?ReleaseID=2228
http://www.fda.gov/cdrh/fusenews/ufb38.html
COURT OF APPEAL
SECOND CIRCUIT
STATE OF LOUISIANA
SHERRY NETHERLAND Plaintiff-Respondent
versus
ETHICON, INC., JOHNSON & JOHNSON, Defendants-Respondents
JOHNSON & JOHNSON HOSPITAL SERVICES
CORP., JOHNSON & JOHNSON HEALTH CARE
SYSTEMS, INC., OWENS & MINOR, INC.,
WILLIS-KNIGHTON HEALTH SYSTEM Defendant-Applicant
http://www.lacoa2.org/35229Remandcw.pdf
Scroll down to the bottom of the page to find FDA recall of Vicryl sutures
http://www.fda.gov/bbs/topics/ENFORCE/ENF00376.html
?Several Respondents-In-Discovery were recently added as defendants to
this suit. They are:
Robert Rady, C.R.N.A., the anesthesiologist who provided anesthesia
during the procedure, and his employer MAC Anesthesia; Lysonix, the
manufacturer of the liposuction machine; and Ethicon, the manufacturer
of the absorbable Vicryl sutures (stitches), as they were subject to a
recall in September of 1994, which they claim have nothing to do with
the case at hand.
Update June 11, 2003:
On February 24, 2003, Cleveland Hair Clinic, both Physicians' Body
entities, Commodore Physician Management and Dr. Kenneth L. Stein and
his service corporation made a confidential settlement, and the
remaining defendants, Robert Rady, Mac Anesthesia, Lysonix and Ethicon
were dismissed with the right to reinstate for one year on April 2,
2003.?
http://www.malpracticeweb.com/stein_ts.htm
?Ethicon Inc., a Johnson & Johnson company based in Somerville,
recalled 3.5 million packages of its Vicryl brand of sutures in 1994 -
under pressure from federal regulators.
However, because hospitals use up sutures quickly, only one-fourth
were returned to the manufacturer and destroyed.
``We recalled the sutures ... not because we believed the product was
contaminated, but because we could not assure (its) sterility,'' said
Susan Odenthal, director of communications at Ethicon, which makes
about 80 percent of the sutures used in this country.
She declined to discuss specific allegations. The company has made
confidential settlements with some plaintiffs, but Odenthal said she
did not know how many.
According to the lawsuit, ``contaminated sutures'' made by Ethicon in
1994 were used in surgeries and other medical procedures, causing
serious injuries and infections.?
http://www.yourlawyer.com/practice/panews.htm?parea=Defective%20Medical%20Devices&&story_id=15
?For those of you who may not know, Ethicon is a subsidiary of Johnson
and Johnson. They manufacture surgical sutures. Some years back,
Ethicon purchased a new piece of equipment intended to sterilize
suture material before packaging. During a routine visit from the FDA,
investigators noted that Ethicon had experienced problems with their
new equipment, putting into question the sterility of the sutures
produced and sold during that period. At the urging of the FDA,
Ethicon recalled the sutures produced while the equipment was not
operating properly. Unfortunately, many of those sutures had already
been used during surgery. Most of the sutures were never returned.?
http://implants.clic.net/tony/Corner/A/0004.html
?Ethicon recalled millions of contaminated sutures (stitches) in 1994
and you have probably not been contacted by your doctor or by Ethicon
about this recall. If you had surgery in West Virginia between May 1,
1994, and December 31, 1997, and subsequently developed an infection
at the site of the surgery, you may be eligible to be a member of this
class. Please see the links to the left for more information.?
http://www.dirtysutures.com/
?It is alleged that Ethicon Inc., a Johnson & Johnson company,
manufactured and distributed contaminated Vicryl® brand sutures to the
public through medical supply distributors, hospitals and physicians.
These sutures are implanted internally. They remain in the body
following surgery and are absorbed into the tissue over time. This
class action lawsuit asserts that these sutures were contaminated and
caused serious injuries and infections and sometimes resulted in
death. Ethicon issued a recall of the sutures in September 1994. By
that time, however, many had already been used in medical procedures
and surgeries, and a large number of the recalled sutures were not
recovered.
In the class action, it is alleged that the Vicryl® sutures sold by
the defendants during the period from May 1, 1994 to December 31,
1997, were defective because they failed to meet the regulatory
definition of "sterile", dramatically increasing the risk of
contracting an infection from those sutures.?
http://www.dirtysutures.com/sutures.htm
?The Company's Ethicon, Inc. subsidiary has over the last several
years had a number of claims and lawsuits filed against it relating to
VICRYL sutures. The actions allege that the sterility of VICRYL
sutures was compromised by inadequacies in Ethicon's systems and
controls, causing patients who were exposed to these sutures to incur
infections which would not otherwise have occurred. Ethicon on several
occasions recalled batches of VICRYL sutures in light of questions
raised about sterility but does not believe any contamination of
suture products in fact occurred.
In November 2003, a trial judge in West Virginia certified for class
treatment all West Virginia residents who had VICRYL sutures implanted
during Class I or II surgeries from May 1, 1994 to December 31, 1997.
The certification is subject to later challenge following the
conclusion of discovery. An October 2004 trial date has been set in
this matter and Ethicon has been and intends to continue vigorously
defending against the claims.?
http://www.investor.jnj.com/governance/EdgarDetail.cfm?CompanyID=JNJ&CIK=200406&FID=200406-04-106&SID=04-00
?CELL PATHWAYS: Spector & Roseman File Complaint in Pennsylvania
CITY OF PHILADELPHIA: Foster Parents Press Forward with Suit
ETHICON, INC.: Under Fire for Dirty Vicryl-Brand Sutures
GENCOR INDUSTRIES: Stull Stull Files Complaint in Florida
GENCOR INDUSTRIES: Bashian Firm Files Complaint in Florida?
http://bankrupt.com/CAR_Public/990226.MBX
?The Company's Ethicon, Inc. subsidiary has over the last several
years had a number of claims and lawsuits filed against it relating to
VICRYL sutures. The actions allege that the sterility of VICRYL
sutures was compromised by inadequacies in Ethicon's systems and
controls, causing patients who were exposed to these sutures to incur
infections which would not otherwise have occurred. Ethicon on several
occasions recalled batches of VICRYL sutures in light of questions
raised about sterility but does not believe any
contamination of suture products in fact occurred. In November 2003, a
trial judge in West Virginia certified for class treatment all West
Virginia residents who had VICRYL sutures implanted during Class I or
II surgeries from May 1, 1994 to December 31, 1997. The certification
is subject to later challenge following the conclusion of discovery.
No trial date has been set in this matter and Ethicon has been and
intends to continue vigorously defending against the claims.? Page 19
http://www.shareholder.com/Common/Edgar/200406/200406-04-81/04-00.pdf
About Vicryl sutures
?Poly(lactide-co-glycolide). Using the polyglycolide and
poly(l-lactide) properties as a starting point, it is possible to
copolymerize the two monomers to extend the range of homopolymer
properties (see Figure 4). Copolymers of glycolide with both l-lactide
and dl-lactide have been developed for both device and drug delivery
applications. It is important to note that there is not a linear
relationship between the copolymer composition and the mechanical and
degradation properties of the materials. For example, a copolymer of
50% glycolide and 50% dl-lactide degrades faster than either
homopolymer (see Figure 5). Copolymers of l-lactide with 25?70%
glycolide are amorphous due to the disruption of the regularity of the
polymer chain by the other monomer. A copolymer of 90% glycolide and
10% l-lactide was developed by Ethicon as an absorbable suture
material under the trade name Vicryl. It absorbs within 3?4 months but
has a slightly longer strength-retention time.?
http://www.devicelink.com/mpb/archive/98/03/002.html
When vicryl sutures are CLEAN, they are highly recommended!
?This study found a significantly higher incidence of superficial
wound infection following surgical treatment for hip fracture when
wound closure was performed using metallic staples. Hence, using
subcuticular vicryl suture for wound closure is a preferable method.?
http://www.josonline.org/pdf/v12i2p191.pdf
Here are excerpts of articles for sale, $29 USD, ?Experimental
Efficacy Study of Coated VICRYL plus Antibacterial Suture in Guinea
Pigs Challenged with Staphylococcus aureus?
http://www.liebertonline.com/doi/abs/10.1089/sur.2004.5.281?prevSearch=allfield%3A%28vicryl%29
?Chemistry and Safety of Triclosan, and Its Use as an Antimicrobial
Coating on Coated VICRYL* Plus Antibacterial Suture (Coated
Polyglactin 910 Suture with Triclosan)? Also $29.00 USD
http://www.liebertonline.com/doi/abs/10.1089/10962960260496334?prevSearch=allfield%3A%28vicryl%29
=================
Panacryl Sutures:
?Of the 505 cases of surgery for prolapse, information on
suture material was available on 423 procedures (83.8%). There were
381 (90.1%) vaginal procedures, 36 (8.5%) abdominal procedures, and 6
(1.4%) laparoscopic procedures. The most common suturerelated
complication was the development of granulation tissue and/or
infection requiring treatment.
Poly L-lactide/glycolide (PanacrylÚ) was found to have the highest
incidence of granulation tissue/infection (53.3%/13.3%)? Page 5 from
this paper from Duke University.
http://www.augs.org/files/public/2004_Oral_Poster_Presentations.pdf
From the ETHICON Wound Closure Manual
?Whenever the integrity of tissue is disrupted by accident or
dissection, the patient becomes vulnerable to infection and
complications. Even though the surgical team may scrupulously adhere
to proper procedure, complications still occur in some patients,
delaying recovery. The two major problems the surgeon may encounter
are infection and wound disruption.
Infection continues to be one of the most serious complications
affecting surgical patients.6 An infection arises from the
introduction of virulent organisms into a susceptible wound. If left
untreated, prolonged illness, gangrene, or even death may result.
Postoperative infections may be classified according to the source of
infection as well as the anatomical and pathophysiological changes
that occur. The key to effective treatment is rapid identification of
the responsible pathogens. A considerable number of infections are of
mixed bacterial origin. As soon as an infection is apparent, treatment
must be initiated. Direct wound treatment may consist of incision and
drainage or debridement of necrotic tissue. A course of antibiotic
treatment must be initiated immediately for cellulitis and fascitis.
A specimen of purulent drainage or tissue for culture is sent prior to
the institution of antibiotic therapy. It is seldom possible to wait
for culture and sensitivity results prior to the start of antibiotics,
and empirical therapy based on suspected sensitivity may be used.
Superficial wounds often do not require incision and drainage or
debridement. Fungal and viral infections may also occur. Their
incidence has steadily increased with the clinical administration of
steroids, immunosuppressive agents, and multiple antibiotic agents.
Wound disruption, or dehiscence, is most often seen in older or
debilitated patients, but may occur at any age. It seems to affect
male patients more often than female patients and most commonly occurs
between the fifth and twelfth postoperative days.?
Because of copyright limitations, I can post only this excerpt from the article.
Page 19 : Complications in Wound Healing
http://www.jnjgateway.com/public/GBENG/6024ETHICON_Wound_Closure_Manual.pdf
From the Mitek BioKnotless Suture Anchor, FULLY ABSORBABLE
BIOCOMPATIBLE PLA ANCHOR Preloaded with PANACRYL?, long-term braided
absorbable suture from ETHICON. Mitek, BioKnotless and PANACRYL are
trademarks of ETHICON, Inc., a Johnson & Johnson company, or its Mitek
Products
Division.
?Indications
The Mitek BioKnotless Suture Anchor is indicated for use
in soft tissue to bone fixation in association with adequate
postoperative immobilization as follows:
Shoulder: Bankart Repair, SLAP lesion repair, acromioclavicular
separation, rotator cuff repair, capsule shift/
capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon
repair/reconstruction, midfoot reconstruction.
Foot: Hallux Valgus reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
Knee: Extra capsular repairs; reattachment of: medial collateral
ligament, lateral collateral ligament, posterior oblique
ligament or joint capsule to tibia and joint capsule closure
to anterior proximal tibia; extra capsular reconstruction,
ITB tenodesis; patellar ligament and tendon avulsions.
Contraindications
1. Surgical procedures other than those listed in the
?Indications? section;
2. Pathological conditions of bone, such as cystic changes
or severe osteopenia, which would compromise secure
anchor fixation;
3. Pathological conditions in the soft tissue to be
attached, which would impair secure fixation by suture;
comminuted bone surface, which would compromise
secure anchor fixation;
4. Physical conditions that would eliminate, or tend to
eliminate, adequate implant support or retard healing,
i.e. blood supply limitation, infection, etc;
5. Conditions that tend to preempt the patient?s ability to
heal or the healing period, such as senility, mental
illness, or alcoholism; attachment of artificial ligaments
or other implants.
WARNINGS
? Since the anchor is absorbable, immobilization by external
support should be employed. The Mitek BioKnotless
Anchor is designed to lock into cancellous bone.
? Do not use this anchor with a drill bit that is not
2.9mm in diameter and that does not generate a precise
diameter drill hole that is at least 18mm in depth.
? In the event that the Mitek BioKnotless Anchor must
be removed, overdrill the original insertion hole or use
curettes or osteotomies to open the cortical surface.
Carefully remove the cancellous bone to expose the
anchor. Use a needle holder or forceps to grasp the
anchor and remove it.
? A Mitek BioKnotless anchor must never be reused. In
the event that the anchor should dislodge from the
inserter or bone site, do not attempt to reattach the
anchor to the inserter. In this case, discard the anchor and inserter
and use a new anchor. Page 2
http://shoulderdoc.co.uk/documents/mitek_bioknotless.pdf
http://shoulderdoc.co.uk/documents/mitek_panalok.pdf
?Screw anchors showed higher load to failure values than nonscrew
designs, and the new biodegradable anchors showed failure loads lower
than the anchors. All anchors were stronger than the suture for which
they are designed.?
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14608318&dopt=Citation
Recommended sutures for soft tissue:
http://www.jnjgateway.com/home.jhtml?loc=USENG&page=viewContent&contentId=fc0de00100001528&parentId=fc0de00100001528
?Panacryl braid deserves serious consideration for coracoclavicular
fixation because of its strength, resistance to deformation, and
bioabsorbable properties.?
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14577722&dopt=Citation
FDA Approval
http://www.fda.gov/cdrh/pdf4/k042233.pdf
A round-table discussion by doctors who have used Panacryl sutures:
?PANACRYL suture exhibits by far the longest strength profile over time, retaining
80% of its original strength through three months.?
?Yes, obviously having 80% strength retained beyond six weeks is
significant. Six weeks is only a marginal amount of time to have soft
tissue heal, either to bone and/or [to] itself. By allowing the
suture strength to go beyond three months, those patients who are
slower in healing and/or are somewhat more active early have a safety
[margin] which other absorbable sutures don?t offer.?
?The obvious advantage of a longer degradation time is that it
minimizes the risk that the repair site will fail prior to biologic
healing.?
http://www.dann.at/pdf/panacryl%202.pdf
?First intention wound healing is the most desirable. Most surgical
wounds heal by first intention if the wound is not contaminated, dead
spaces are closed, tissue is handled gently, hemostasis is achieved,
and the tissues are approximated accurately.
Wounds heal by secondary intention if there are post-operative
complications such as infection, wound dehiscence, excessive scar, or
excessive drainage. If sutures were used prior to the development of
the complication, they are removed and the wound is allowed to heal by
forming granulation tissue from the bottom of the wound outward. If an
infection is present when the surgical procedure takes place, the
surgeon may not attempt any suturing of the wound, and allow the wound
to head by secondary intention. This type of healing takes much longer
than healing by first intention.
The last type of wound healing is by third intention. When granulation
tissue has developed along the edges of a wound the surgeon may use
large retention type sutures to assist in healing. Third intention
healing is used when there is gross infection, or after tissue has
been lost due to traumatic injury or surgical debridement.?
?Obese patients are at risk for post-operative wound infections
because excess adipose tissue at the wound site may prevent good
approximation of tissues. Adipose tissue does not have a good blood
supply, therefore making it vulnerable to trauma or infection.
The nutritional status of the patient can effect wound healing. A lack
of carbohydrates, proteins, zinc, and vitamins can cause a delay in
healing. Without adequate nutrition, collagen synthesis-which is the
basis for wound healing-- cannot properly occur.
Dehydration, causing electrolyte imbalance, not only can affect
cardiac, kidney, and hormonal function, it also can decrease
oxygenation to the tissues, thereby affecting wound healing. Lack of
blood supply at the wound site can also slow healing. Areas of the
body such as the face and neck receive the most blood supply and heal
the fastest, whereas areas such as extremities take longer to heal.
Poor circulation in extremities, such as in the diabetic patient,
causes even longer healing times. Chronic diseases also can cause
post-operative complications.?
?Synthetic sutures degrade at a slower rate than natural sutures and
with less tissue reaction. Synthetic sutures offer a more consistent
performance, as well. There is little or no variation from batch to
batch, as there is with catgut suture material. Absorbable sutures are
used to close deep connective tissues following trauma or surgery.
Wound tissues must be approximated and supported by the sutures until
healing takes place. Synthetic or natural materials may be used, but
synthetic materials have almost totally replaced the use of catgut in
surgery today.?
http://www.infectioncontroltoday.com/articles/191feat3.html
Dissolvable Sutures
?Absorbable sutures have two basic advantages: less chronic foreign
body reactions and reduced infections. Absorbable sutures are
temporary due to their ability to be absorbed by the body. They lose
most of their tensile strength in less than 60 days. Though some ie.
catgut may remain in the tissue for a long period of time.?
http://www.sas.upenn.edu/~jafield/Sutures.html
Panacryl (Mitek, a division of Ethicon, Somerville)
Notice that someone is selling EXPIRED Ethicon sutures on eBay!
http://search.ebay.com/Monocryl_W0QQfkrZ1QQfnuZ1QQxpufuZx
Hope this helps you out! If this is not the information you are
seeking, please do not rate this answer without requesting an Answer
Clarification first. This will allow me to assist you further, if
possible.
Sincerely, Crabcakes
Search Terms
Ethicon sutures recalled
vicryl sutures + not sterilized + 1994
1994 recall vicryl sutures |
