Fw: FINALLY: local complication data on saline implants

[Guest guest]

We have finally completed our compilation of all the FDA's analyses of

Mentor

and McGhan's data on complications, which was presented to the FDA on March

1-3 of this year. It is long, but we have tried to make it as easy to

understand as possible. If you have any question, send us a note. This

entire article is also on our website, the third article in our Breast

Implant section. Visit us at <A

HREF= " www.cpr4womenandfamilies.org " >www.cpr4w

omenandfamilies.org</A>

Remember, these were the safety data that convinced the FDA to approve

saline

breast implants. Now you will see why the reporters at the meeting were so

shocked.

Best Wishes,

Zuckerman

Local Complications of Saline Breast Implants

These CPR fact sheets are based on the FDA's analyses of data collected by

Mentor and McGhan on their saline breast implants. Despite very high

complication rates, these studies were the basis for the FDA's decision to

approve the saline breast implants made by these manufacturers.

FDA's Analysis of the Study of Mentor Saline Breast Implants

Presented at the FDA Meeting March 1-3, 2000

Augmentation Patients

First-Time Implant Patients

Mentor conducted a study of 1,264 women who got saline breast implants for

augmentation; only 76% completed the three-year study. Women who had their

implants removed were not followed after removal, so additional

complications

they experienced were not included. The many women who left the study for

other reasons did not have their complications reported after they left the

study either. Complications were measured up until a woman left the study,

but percentages were based on all 1,264 women. Therefore, the percentage of

women having complications is almost certainly higher than reported here.

Forty-three percent of augmentation patients had at least one complication

within three years.

32% had wrinkling, asymmetry, sagging, or scarring

15% had nipple changes

13% needed additional surgery

10% had severe capsular contracture (hardening of breast)

8% had their implants removed

5% had breast pain

3% had leakage or deflation

2% had infection

2% had implant palpability

About one of every seven women (13%) had at least one additional surgery

within the first three years. Of those that had additional surgery:

32% were to replace the implant

22% were due to capsular contracture or other capsule problems

19% were for scar or wound revision

8% were for repositioning the implant

8% were for adjusting the saline

6% were for sagging

3% were removed without replacement

2% were for biopsy or cyst removal

Eight percent of the women had their implants removed. Of those implants,

most were removed because of complications, not just to change the size or

shape. Patients having more than one reason for implant removal were counted

only once using the following hierarchy: deflation, contracture, infection,

necrosis/extrusion, hematoma/seroma, asymmetry, pain, patient request,

other.

Reasons for removal included:

37% were removed to change the size or shape

23% were removed due to leakage or deflation

16% were removed due to capsular contracture

16% were removed due to asymmetry, wrinkling, sagging, or scarring

5% were removed due to infection

2% were removed due to hematoma or seroma (blood or fluid accumulation

around

the implant)

Patients with Implant Replacements

Mentor also performed a study of augmentation patients who had implants

removed and replaced. They studied the three-year risk rate on a per implant

(not per patient) basis. 120 implants were replaced. This study is important

because previous studies have been on new patients, not women with implant

replacements. Unfortunately, the results suggest that the replacement

implants have many problems as well.

More than one in three replacement implants (36%) had at least one

complication within three years. Complications included:

21% caused wrinkling, asymmetry, or scarring

16% caused the need for additional surgery

12% needed to be removed again

8% caused severe capsular contracture

4% leaked or deflated

3% caused breast pain

2% caused hematoma

FDA's Analysis of the Study of Mentor Saline Breast Implants

Presented at the FDA Meeting March 1-3, 2000

Reconstruction Patients

First-Time Implant Patients

Mentor conducted a study of 428 women who got saline breast implants for

reconstruction; 68% of whom completed the three-year study. Women who had

their implants removed were not followed after removal, so additional

complications they experienced were not included. The many women who left

the

study for other reasons did not have their complications reported after they

left the study either. Complications were measured up until a woman left the

study, but percentages were based on all 428 women. Therefore, the

percentage

of women having complications is almost certainly higher than reported here.

Nearly three-quarters (73%) of reconstruction patients had at least one

complication within three years.

53% had asymmetry, wrinkling, or scarring

44% had severe capsular contracture

40% needed additional surgery

35% lost nipple sensation

27% got their implant(s) removed

17% had breast pain

9% had infections

9% had leakage or deflation

8% had irritation or inflammation

7% had hematoma or seroma (blood or fluid accumulation around the implant)

6% had delayed wound healing

2% had extrusion (implant coming out through the skin)

2% had necrosis (tissue dying around the implant)

Forty percent of the women who received implants for reconstruction had at

least one additional surgery within the first three years. Of those that had

additional surgery:

28% were due to capsular contracture

19% were for replacement

13% were for scar or wound revision

11% were removal without replacement

8% were for nipple problems

7% were for adjusting the saline

6% were for repositioning of the implant

More than one-quarter of the women (27%) had their implants removed. Of

these

implants removed, 93% were because of complications, and only 6% were to

change the size. Patients having more than one reason for implant removal

were counted only once using the following hierarchy: deflation,

contracture,

infection, necrosis/extrusion, hematoma/seroma, asymmetry, pain, patient

request, other.

Reasons for removal included:

26% were due to infection

26% were due to capsular contracture

22% were due to leakage or deflation

11% were due to asymmetry, wrinkling, sagging, or scarring

6% were for a change in size

5% were due to necrosis or extrusion

3% were due to breast pain

Patients with Implant Replacements

Mentor also performed a study of reconstruction patients who had implants

removed and replaced. Overall, they studied the three-year risk rate on a

per

implant basis. 76 implants were replaced. This is the first time this group

has been studied. Unfortunately, the results suggest that the replacement

implants have many problems as well.

More than half (61%) of the replaced implants caused least one complication

within three years.

31% caused a need for additional surgery

23% leaked or deflated

21% needed to be removed

17% caused severe capsular contracture

16% caused wrinkling

13% caused breast pain

5% caused infections

3% caused irritation or inflammation

3% caused seromas

FDA's Analysis of the Study of McGhan Saline Breast Implants

Presented at the FDA Meeting March 1-3, 2000

Augmentation Patients

First-Time Implant Patients

McGahn conducted a study of 901 women who got saline breast implants for

augmentation; 75% of whom completed the three-year study. Women who had

their

implants removed were not followed after removal, so additional

complications

they experienced were not included. The many women who left the study for

other reasons did not have their complications reported after they left the

study either. Complications were measured up until a woman left the study,

but percentages were based on all 901 women. Therefore, the percentage of

women having complications is almost certainly higher than reported here.

Preliminary data showed that 60% of women experienced at least one

complication within four years. At three years after implantation,

complication rates were as follows:

27% had wrinkling, asymmetry, or scarring

21% required additional surgery

17 % had nipple-related problems

16% had breast pain

9% had severe capsular contracture (hardening of breast)

9% had implant palpability/visibility

8% had their implants removed

5% had leakage or deflation

5% had hematoma or seroma (blood or fluid accumulation around the implant)

Of the 402 additional surgeries, the majority was due to complications, not

due to patient requests for a change in size. Of those that had additional

surgery:

30% were to replace the implant

19% were for capsule procedures

11% were to change the saline fill

8% were for scar revision or wound repair

7% were because breasts sagged

7% were to aspirate

5% were to reposition the implant

4% were for biopsy or lump removal

3% were removed without replacement

Of the 8% of women who had their implants removed, the main reason for

removal was equally likely to be because of leakage/deflation or to change

the size or style. Percentages are per implant, not per patient. 132

implants

were removed.

42% were due to leakage or deflation

42% were to change the size or style

6% were due to severe capsular contracture

5% were due to wrinkling, asymmetry, or malposition

3% were due to infection, implant extrusion, or injury during surgery

2% were due to breast pain

1% were due to infection

Patients with Implant Replacements

McGahn also performed a two-year study of 108 implants that were replaced in

69 women who had problems with their first implants. This is the first time

this group has been studied. Unfortunately, the results suggest that the

replacement implants have many problems as well.

Three in five replacement implants (59%) caused complications within two

years of the replacement. Complications included:

13% caused breast pain

11% caused the need for additional surgery

9% leaked or deflated

7% caused capsular contracture

5% needed to be removed again

1% caused an infection

FDA's Analysis of the Study of McGhan Saline Breast Implants

Presented at the FDA Meeting March 1-3, 2000

Reconstruction Patients

First-Time Implant Patients

McGahn conducted a study of 237 women who got saline breast implants for

reconstruction; 71% of whom completed the three-year study. Women who had

their implants removed were not followed after removal, so additional

complications they experienced were not included. The many women who left

the

study for other reasons did not have their complications reported after they

left the study either. Complications were measured up until a woman left the

study, but percentages were based on all 237 women. Therefore, the

percentage

of women having complications is almost certainly higher than reported here.

Preliminary data showed that 84% of women experienced at least one

complication within four years. At three years after implantation,

complication rates were as follows:

62% had asymmetry, wrinkling, or scarring

39% needed additional surgery

25% had severe capsular contracture (hardening of breast tissue)

23% had the implant removed

20% had implant palpability or visibility

15% had breast pain

12% lost nipple sensation

7% had irritation or inflammation

6% had leakage or deflation

5% had infections

5% had calcification of the capsule

Of the 151 additional surgeries, the majority was due to complications. Of

those that had additional surgery:

30% were to replace the implant

13% were to revise a scar or repair a wound

13% were for unknown causes

12% were for capsule problems

11% were removed without replacement

5% were to aspiration

5% were for a biopsy or lump removal

5% were to change the saline fill

4% were to reposition the implant

Of the 23% who had their implants removed, the main reason for removal was

most often leakage or deflation. Percentages are per implant, not per

patient. 62 implants were removed.

31% due to leakage or deflation

23% to change the size or style

21% due to capsular contracture

10% due to an infection

10% due to wrinkling, asymmetry or malposition

7% due to implant extrusion

Patients with Implant Replacements

McGahn also performed a two-year study of 37 reconstruction patients who

received implants as replacements. This is the first time this group has

been

studied. Unfortunately, the results suggest that the replacement implants

have many problems as well.

73% of replacement implants caused complications within two years of the

replacement. Over half required additional surgery. Complications included:

53% needed additional surgery

48% had severe capsular contracture

35% had breast pain.

26% needed to be removed

7% caused an infection

5% leaked or deflated

Zuckerman, Ph.D.

Executive Director

National Center for Policy Research for Women and Families

1444 Eye Street, NW

Suite 900

Washington, DC 20005