myrl

Thanks to Pam Dowd for sending us the following from the evidentiary
files of breast implant litigation. It's a pretty amazing do***ent...
Myrl


MEF000024659/1118

1985 letter: Plastic and Reconstructive Surgery, Vol 75, No.
3/Correspondence
Author Harry Hayes, Jr., M.D.

HAND AND ARM INJURIES FOLLOWING EXTERNAL CAPSULOTOMIES

Sir:

This letter presents the results of a recent mail survey or the active
members of the American Society of Plastic and Reconstructive Surgeons
with regard to hand and arm injuries sustained by plastic surgeons as a
result of external capsulotomies of augmented breasts. A total of 2050
questionnaires were sent out and 1097 (54 percent of the total
membership) responded. The responses were grouped into three
categories. In group 1 were those surgeons who do not perform external
capsulotomies and therefore were not at risk: there were 211 of these.
Group 2, consisting of 633 surgeons, did perform external
capsulotomies but had never had symptoms suggesting injury from the
procedure. Group 3 consisted of 253 surgeons who do perform
capsulotomies and had sustained injuries: their responses were
****yzed in detail.

There were several interesting comments from group 1:

1. "I quit this 3 years ago because all contractures treated by
closed capsulotomy recurred."
2. "The whole procedure is irrational, unhelpful, and usually
productive of further and more severe spherical contracture."
3. Response from a female plastic surgeon: "I can't even open a
pickle jar, much less crack a capsule, but I have heard the guys
complain."

In the 653 replies from surgeons who do capsulotomies and had never had
an injury, there were a number of interesting and pithy comments:


1. "I have a personal rule that I never use enough force to
hurt myself, and consequently, most of my capsulotomy attempts are
unsuccessful."
2. "I do not feel that publishing the results of this survey
will do anything to enhance the current status of augmentation surgery
in the eyes of the public, the media, and the FDA."
3. "When the results of your survey are published, the headline
in the newspaper will read: Surgeons Injury Hands Squeezing
Breasts."
4. "Around here we call this breast buster's thumb."
5. "If you will life weights and get in shape, then you will be
able to break those capsules without any pain."
6. "I had never had an injury following a closed capsulotomy,
but I have now developed 'fat****er's arm,' so that now when I do
an external capsulotomy, I have pain in my brachioradialis."

The 253 surgeons who reported hand or arm injuries represented 29
percent of the surgeons at risk. This is a much higher percentage than
reported in a previous study. 1

These responses were studied for preexisting disease or injury, method
of external capsulotomy employed, area or areas of involvement,
treatment, degree of recovery, restriction of activities, duration of
symptoms, and any observation or insights on the part of the surgeon.

Preexisting diseases or injuries were mentioned by numerically very few
of the respondents; these included gamekeeper's thumb, previous joint
dislocation, old ski pole injury, tennis elbow, and several instances
of posttraumatic arthritis. The methods of external capsulotomy listed
included open hands using the ****** to help encircle the breasts, the
closed-fist technique with most of the power coming from the pectoralis
muscles, the heel of the palm technique (that is, not using the
******) with the fingers either extended as in praying or interlocked,
the use of an assistant (nurse or resident) to supply power over the
surgeon's hands, and some type of mechanical device. 2-4 Surgeons who
sustained thumb injuries usually switched to a method not employing the
thumb.

The area or areas of involvement were as follows:

1. Thumb, 180
2. Elbow, 17
3. Wrist, 14
4. Hand, 10
5. Shoulder, 9
6. Forearm, 8
7. Thumb and wrist, 4
8. Thumb and index, 3
9. Thumb and elbow, 2
10. Not specified, 2
11. Pectoralis muscle, 1
12. Neck, 1
13. Nerve, arm, 1
14. Muscle, arm1

The thumb, either or both, was involved in over 75 percent of the
reported injuries. We could find no relationship between the area of
involvement, the degree of recovery, and the age of the surgeon.

Recovery was divided into complete, partial (still bothered), or
recurrent when doing any further external capsulotomies. Most of the
surgeons did have a complete or nearly to so recovery. Some were still
having trouble months or even years afterwards or whenever they
attempted a difficult external capsulotomy. All the groups had some
restriction of their activities. The least restriction noted was pain
and/or inability to do any more external capsulotomies on the same day.
Other complaints mentioned were no golf or tennis. There were
restrictions noted secondary to the splinting of the injured area,
there were a few surgeons who were unable to operate for a few days up
to a few weeks, and several more who had to close down their practice
for a few months.

The most common treatment was rest and immobilization with either a
plastic or metal thumb or wrist splint or an orthoplast splint. One
plastic surgeon developed a special splint for treating these injuries
in his colleagues. 5 Aspirin, other salicylates, indomethacin,
methocarbamol, and a few other drugs were mentioned. Several surgeons
required one or more cortisone injections. There were two instances of
surgery for late sequale of these injuries.

A perhaps not surprising number of surgeons have become disenchanted
and either no longer do any external capsulotomies or have cut back
considerably on the number being done. Only a few continue to do the
very difficult capsulotomies; several of these recommended bicycling to
increase the grip or Nautilus to increase the strength in the upper
arms. A significant number of surgeons mentioned that they had either
switched to subpectoral implants or had quit using smooth implants in
an attempt to cut down on the incidence of firmness.

In summary, there is a significant risk of disability to the surgeon
doing external capsulotomies. However, the incidence may be expected
to decrease as the number of external capsulotomies decreases.

Harry Hayes, Jr. MD
Suite 310
No. 1 St Vincent Circle
Little Rock, Arkansas 72205

References:
1. Nelson, G.D. Complications of closed compression after
augmentation mammaplasty. Plast. Reconstr. Surg. 66: 71, 1980
2. Muldrow, L. Personal communication, 1984
3. Frank, D.H. and Robson, M.C. A pneumatic tourniquet as an aid
to release of capsular contracture around a breast implant. Plast
Reconstr. Surg. 61: 612, 1978
4. Snyder, G.B., and Nestor, J. An instrument for closed
compression of capsular contracture of the breast. Ann. Plast. Surg.
4: 245, 1980
5. LeWinn, L.R. Personal communication, 1984

MEF000024658/1118


Article Review, 1989, identified only with initials SAE

There is a significant risk of disability to the surgeon doing external
capsulotomies. The incidence may be expected to decrease as the number
of external capsulotomies decreases. This letter presents the results
of a mail survey of the active members of the American Society of
Plastic and Reconstructive Surgeons. Fifty-Four percent of the total
membership responded. Three categories were group 1surgeons who did
not perform external capsulotomies (211), group 2did external
capsulotomies but never had an injury from doing the procedure (633),
and group 3(253) surgeons who perform capsulotomies and had sustained
injuries. The 253 surgeons who reported hand or arm injuries
represented 29% of the surgeons at risk. The thumb, either one or
both, was involved in over 75 % of the reported injuries. All the
group had some restriction of activities. One plastic surgeon
developed a special splint for treating these injuries in his
colleagues. Several surgeon required one or more cortisone injections
and two instances of surgery for late sequale on these injuries. A
number of surgeons have become disenchanted and either no longer do
external capsulotomies or have cut back on the number done. A
significant number of surgeons mentioned the had switched to
subpectoral implants or had quit using smooth implants in an attempt to
cut down on the incidence of firmness.

myrl

Thanks to Pam Dowd for sending us the following from the evidentiary
files of breast implant litigation. It's a pretty amazing do***ent...
Myrl


MEF000024659/1118

1985 letter: Plastic and Reconstructive Surgery, Vol 75, No.
3/Correspondence
Author Harry Hayes, Jr., M.D.

HAND AND ARM INJURIES FOLLOWING EXTERNAL CAPSULOTOMIES

Sir:

This letter presents the results of a recent mail survey or the active
members of the American Society of Plastic and Reconstructive Surgeons
with regard to hand and arm injuries sustained by plastic surgeons as a
result of external capsulotomies of augmented breasts. A total of 2050
questionnaires were sent out and 1097 (54 percent of the total
membership) responded. The responses were grouped into three
categories. In group 1 were those surgeons who do not perform external
capsulotomies and therefore were not at risk: there were 211 of these.
Group 2, consisting of 633 surgeons, did perform external
capsulotomies but had never had symptoms suggesting injury from the
procedure. Group 3 consisted of 253 surgeons who do perform
capsulotomies and had sustained injuries: their responses were
****yzed in detail.

There were several interesting comments from group 1:

1. "I quit this 3 years ago because all contractures treated by
closed capsulotomy recurred."
2. "The whole procedure is irrational, unhelpful, and usually
productive of further and more severe spherical contracture."
3. Response from a female plastic surgeon: "I can't even open a
pickle jar, much less crack a capsule, but I have heard the guys
complain."

In the 653 replies from surgeons who do capsulotomies and had never had
an injury, there were a number of interesting and pithy comments:


1. "I have a personal rule that I never use enough force to
hurt myself, and consequently, most of my capsulotomy attempts are
unsuccessful."
2. "I do not feel that publishing the results of this survey
will do anything to enhance the current status of augmentation surgery
in the eyes of the public, the media, and the FDA."
3. "When the results of your survey are published, the headline
in the newspaper will read: Surgeons Injury Hands Squeezing
Breasts."
4. "Around here we call this breast buster's thumb."
5. "If you will life weights and get in shape, then you will be
able to break those capsules without any pain."
6. "I had never had an injury following a closed capsulotomy,
but I have now developed 'fat****er's arm,' so that now when I do
an external capsulotomy, I have pain in my brachioradialis."

The 253 surgeons who reported hand or arm injuries represented 29
percent of the surgeons at risk. This is a much higher percentage than
reported in a previous study. 1

These responses were studied for preexisting disease or injury, method
of external capsulotomy employed, area or areas of involvement,
treatment, degree of recovery, restriction of activities, duration of
symptoms, and any observation or insights on the part of the surgeon.

Preexisting diseases or injuries were mentioned by numerically very few
of the respondents; these included gamekeeper's thumb, previous joint
dislocation, old ski pole injury, tennis elbow, and several instances
of posttraumatic arthritis. The methods of external capsulotomy listed
included open hands using the ****** to help encircle the breasts, the
closed-fist technique with most of the power coming from the pectoralis
muscles, the heel of the palm technique (that is, not using the
******) with the fingers either extended as in praying or interlocked,
the use of an assistant (nurse or resident) to supply power over the
surgeon's hands, and some type of mechanical device. 2-4 Surgeons who
sustained thumb injuries usually switched to a method not employing the
thumb.

The area or areas of involvement were as follows:

1. Thumb, 180
2. Elbow, 17
3. Wrist, 14
4. Hand, 10
5. Shoulder, 9
6. Forearm, 8
7. Thumb and wrist, 4
8. Thumb and index, 3
9. Thumb and elbow, 2
10. Not specified, 2
11. Pectoralis muscle, 1
12. Neck, 1
13. Nerve, arm, 1
14. Muscle, arm1

The thumb, either or both, was involved in over 75 percent of the
reported injuries. We could find no relationship between the area of
involvement, the degree of recovery, and the age of the surgeon.

Recovery was divided into complete, partial (still bothered), or
recurrent when doing any further external capsulotomies. Most of the
surgeons did have a complete or nearly to so recovery. Some were still
having trouble months or even years afterwards or whenever they
attempted a difficult external capsulotomy. All the groups had some
restriction of their activities. The least restriction noted was pain
and/or inability to do any more external capsulotomies on the same day.
Other complaints mentioned were no golf or tennis. There were
restrictions noted secondary to the splinting of the injured area,
there were a few surgeons who were unable to operate for a few days up
to a few weeks, and several more who had to close down their practice
for a few months.

The most common treatment was rest and immobilization with either a
plastic or metal thumb or wrist splint or an orthoplast splint. One
plastic surgeon developed a special splint for treating these injuries
in his colleagues. 5 Aspirin, other salicylates, indomethacin,
methocarbamol, and a few other drugs were mentioned. Several surgeons
required one or more cortisone injections. There were two instances of
surgery for late sequale of these injuries.

A perhaps not surprising number of surgeons have become disenchanted
and either no longer do any external capsulotomies or have cut back
considerably on the number being done. Only a few continue to do the
very difficult capsulotomies; several of these recommended bicycling to
increase the grip or Nautilus to increase the strength in the upper
arms. A significant number of surgeons mentioned that they had either
switched to subpectoral implants or had quit using smooth implants in
an attempt to cut down on the incidence of firmness.

In summary, there is a significant risk of disability to the surgeon
doing external capsulotomies. However, the incidence may be expected
to decrease as the number of external capsulotomies decreases.

Harry Hayes, Jr. MD
Suite 310
No. 1 St Vincent Circle
Little Rock, Arkansas 72205

References:
1. Nelson, G.D. Complications of closed compression after
augmentation mammaplasty. Plast. Reconstr. Surg. 66: 71, 1980
2. Muldrow, L. Personal communication, 1984
3. Frank, D.H. and Robson, M.C. A pneumatic tourniquet as an aid
to release of capsular contracture around a breast implant. Plast
Reconstr. Surg. 61: 612, 1978
4. Snyder, G.B., and Nestor, J. An instrument for closed
compression of capsular contracture of the breast. Ann. Plast. Surg.
4: 245, 1980
5. LeWinn, L.R. Personal communication, 1984

MEF000024658/1118


Article Review, 1989, identified only with initials SAE

There is a significant risk of disability to the surgeon doing external
capsulotomies. The incidence may be expected to decrease as the number
of external capsulotomies decreases. This letter presents the results
of a mail survey of the active members of the American Society of
Plastic and Reconstructive Surgeons. Fifty-Four percent of the total
membership responded. Three categories were group 1surgeons who did
not perform external capsulotomies (211), group 2did external
capsulotomies but never had an injury from doing the procedure (633),
and group 3(253) surgeons who perform capsulotomies and had sustained
injuries. The 253 surgeons who reported hand or arm injuries
represented 29% of the surgeons at risk. The thumb, either one or
both, was involved in over 75 % of the reported injuries. All the
group had some restriction of activities. One plastic surgeon
developed a special splint for treating these injuries in his
colleagues. Several surgeon required one or more cortisone injections
and two instances of surgery for late sequale on these injuries. A
number of surgeons have become disenchanted and either no longer do
external capsulotomies or have cut back on the number done. A
significant number of surgeons mentioned the had switched to
subpectoral implants or had quit using smooth implants in an attempt to
cut down on the incidence of firmness.

myrl

Thanks to Pam Dowd for sending us the following from the evidentiary
files of breast implant litigation. It's a pretty amazing do***ent...
Myrl


MEF000024659/1118

1985 letter: Plastic and Reconstructive Surgery, Vol 75, No.
3/Correspondence
Author Harry Hayes, Jr., M.D.

HAND AND ARM INJURIES FOLLOWING EXTERNAL CAPSULOTOMIES

Sir:

This letter presents the results of a recent mail survey or the active
members of the American Society of Plastic and Reconstructive Surgeons
with regard to hand and arm injuries sustained by plastic surgeons as a
result of external capsulotomies of augmented breasts. A total of 2050
questionnaires were sent out and 1097 (54 percent of the total
membership) responded. The responses were grouped into three
categories. In group 1 were those surgeons who do not perform external
capsulotomies and therefore were not at risk: there were 211 of these.
Group 2, consisting of 633 surgeons, did perform external
capsulotomies but had never had symptoms suggesting injury from the
procedure. Group 3 consisted of 253 surgeons who do perform
capsulotomies and had sustained injuries: their responses were
****yzed in detail.

There were several interesting comments from group 1:

1. "I quit this 3 years ago because all contractures treated by
closed capsulotomy recurred."
2. "The whole procedure is irrational, unhelpful, and usually
productive of further and more severe spherical contracture."
3. Response from a female plastic surgeon: "I can't even open a
pickle jar, much less crack a capsule, but I have heard the guys
complain."

In the 653 replies from surgeons who do capsulotomies and had never had
an injury, there were a number of interesting and pithy comments:


1. "I have a personal rule that I never use enough force to
hurt myself, and consequently, most of my capsulotomy attempts are
unsuccessful."
2. "I do not feel that publishing the results of this survey
will do anything to enhance the current status of augmentation surgery
in the eyes of the public, the media, and the FDA."
3. "When the results of your survey are published, the headline
in the newspaper will read: Surgeons Injury Hands Squeezing
Breasts."
4. "Around here we call this breast buster's thumb."
5. "If you will life weights and get in shape, then you will be
able to break those capsules without any pain."
6. "I had never had an injury following a closed capsulotomy,
but I have now developed 'fat****er's arm,' so that now when I do
an external capsulotomy, I have pain in my brachioradialis."

The 253 surgeons who reported hand or arm injuries represented 29
percent of the surgeons at risk. This is a much higher percentage than
reported in a previous study. 1

These responses were studied for preexisting disease or injury, method
of external capsulotomy employed, area or areas of involvement,
treatment, degree of recovery, restriction of activities, duration of
symptoms, and any observation or insights on the part of the surgeon.

Preexisting diseases or injuries were mentioned by numerically very few
of the respondents; these included gamekeeper's thumb, previous joint
dislocation, old ski pole injury, tennis elbow, and several instances
of posttraumatic arthritis. The methods of external capsulotomy listed
included open hands using the ****** to help encircle the breasts, the
closed-fist technique with most of the power coming from the pectoralis
muscles, the heel of the palm technique (that is, not using the
******) with the fingers either extended as in praying or interlocked,
the use of an assistant (nurse or resident) to supply power over the
surgeon's hands, and some type of mechanical device. 2-4 Surgeons who
sustained thumb injuries usually switched to a method not employing the
thumb.

The area or areas of involvement were as follows:

1. Thumb, 180
2. Elbow, 17
3. Wrist, 14
4. Hand, 10
5. Shoulder, 9
6. Forearm, 8
7. Thumb and wrist, 4
8. Thumb and index, 3
9. Thumb and elbow, 2
10. Not specified, 2
11. Pectoralis muscle, 1
12. Neck, 1
13. Nerve, arm, 1
14. Muscle, arm1

The thumb, either or both, was involved in over 75 percent of the
reported injuries. We could find no relationship between the area of
involvement, the degree of recovery, and the age of the surgeon.

Recovery was divided into complete, partial (still bothered), or
recurrent when doing any further external capsulotomies. Most of the
surgeons did have a complete or nearly to so recovery. Some were still
having trouble months or even years afterwards or whenever they
attempted a difficult external capsulotomy. All the groups had some
restriction of their activities. The least restriction noted was pain
and/or inability to do any more external capsulotomies on the same day.
Other complaints mentioned were no golf or tennis. There were
restrictions noted secondary to the splinting of the injured area,
there were a few surgeons who were unable to operate for a few days up
to a few weeks, and several more who had to close down their practice
for a few months.

The most common treatment was rest and immobilization with either a
plastic or metal thumb or wrist splint or an orthoplast splint. One
plastic surgeon developed a special splint for treating these injuries
in his colleagues. 5 Aspirin, other salicylates, indomethacin,
methocarbamol, and a few other drugs were mentioned. Several surgeons
required one or more cortisone injections. There were two instances of
surgery for late sequale of these injuries.

A perhaps not surprising number of surgeons have become disenchanted
and either no longer do any external capsulotomies or have cut back
considerably on the number being done. Only a few continue to do the
very difficult capsulotomies; several of these recommended bicycling to
increase the grip or Nautilus to increase the strength in the upper
arms. A significant number of surgeons mentioned that they had either
switched to subpectoral implants or had quit using smooth implants in
an attempt to cut down on the incidence of firmness.

In summary, there is a significant risk of disability to the surgeon
doing external capsulotomies. However, the incidence may be expected
to decrease as the number of external capsulotomies decreases.

Harry Hayes, Jr. MD
Suite 310
No. 1 St Vincent Circle
Little Rock, Arkansas 72205

References:
1. Nelson, G.D. Complications of closed compression after
augmentation mammaplasty. Plast. Reconstr. Surg. 66: 71, 1980
2. Muldrow, L. Personal communication, 1984
3. Frank, D.H. and Robson, M.C. A pneumatic tourniquet as an aid
to release of capsular contracture around a breast implant. Plast
Reconstr. Surg. 61: 612, 1978
4. Snyder, G.B., and Nestor, J. An instrument for closed
compression of capsular contracture of the breast. Ann. Plast. Surg.
4: 245, 1980
5. LeWinn, L.R. Personal communication, 1984

MEF000024658/1118


Article Review, 1989, identified only with initials SAE

There is a significant risk of disability to the surgeon doing external
capsulotomies. The incidence may be expected to decrease as the number
of external capsulotomies decreases. This letter presents the results
of a mail survey of the active members of the American Society of
Plastic and Reconstructive Surgeons. Fifty-Four percent of the total
membership responded. Three categories were group 1surgeons who did
not perform external capsulotomies (211), group 2did external
capsulotomies but never had an injury from doing the procedure (633),
and group 3(253) surgeons who perform capsulotomies and had sustained
injuries. The 253 surgeons who reported hand or arm injuries
represented 29% of the surgeons at risk. The thumb, either one or
both, was involved in over 75 % of the reported injuries. All the
group had some restriction of activities. One plastic surgeon
developed a special splint for treating these injuries in his
colleagues. Several surgeon required one or more cortisone injections
and two instances of surgery for late sequale on these injuries. A
number of surgeons have become disenchanted and either no longer do
external capsulotomies or have cut back on the number done. A
significant number of surgeons mentioned the had switched to
subpectoral implants or had quit using smooth implants in an attempt to
cut down on the incidence of firmness.

The ASPRS is quite AMAZING!!! They didn't care a fig about the pain
and suffering they inflicted on their patients, but they were sure
concerned about their poor little ******, wrists and pectoral muscles
that might keep them from skiing or playing golf!

My implants were under the muscle and never got hard. I can only
imagine the pain the women who underwent the procedures suffered.
Wonder if any of the women had a knee-jerk reaction that put their PS
out of commission a few days for other parts of his life.

Pam

myrl

Pam-
That was my take on that piece too!. . .The more I thought about it,
the more upsetting it was. The whole study was about their pain and
suffering! If plastic surgeons were hurting and injuring themselves so
much while doing these procedures, than the process had to have been
near excrutiating for the women. I went through it once (about a month
after implantation). . .It was very painful, and brought significant
tears to my eyes.

myrl

Pam-
That was my take on that piece too!. . .The more I thought about it,
the more upsetting it was. The whole study was about their pain and
suffering! If plastic surgeons were hurting and injuring themselves so
much while doing these procedures, than the process had to have been
near excrutiating for the women. I went through it once (about a month
after implantation). . .It was very painful, and brought significant
tears to my eyes.

It's a wonder none of the women sued their plastic butts over this
procedure. From reading between the lines, this was not the first time
they did a survey amongst themselves to track their injuries.

Not a smart bunch, huh! If a procedure hurt THEM all that much, why
would they go ahead and do it again. Buch of sadists, if you ask
me...or would that be masochists?