Fw: STUDY OF RUPTURE OF SILICONE GEL-FILLED BREAST IMPLANTS

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From: " ilena rose " <ilena@...>

Sent: Saturday, April 21, 2001 9:16 PM

Subject: STUDY OF RUPTURE OF SILICONE GEL-FILLED BREAST IMPLANTS

(Important Repost)

May 19, 2000

STUDY OF RUPTURE OF SILICONE GEL-FILLED BREAST IMPLANTS

(MRI COMPONENT)

An FDA study on rupture of silicone gel-filled breast implants was

presented at the Sixth World Biomaterials Congress on May 18, 2000.

The study, performed in Birmingham, Alabama, involved women who had their

first breast implant before 1988. The majority of the 907 women in this

study had silicone gel-filled breast implants. Some women who had silicone

gel-filled breast implants were invited to undergo a magnetic resonance

imaging (MRI) examination of their breasts to determine whether their

implants had ruptured. MRI allows the radiologist to see the breast implant

while it is still inside the breast.

FDA conducted this study because of concerns about the frequency and

results of rupture. Rupture is a concern because:

· Rupture of silicone gel-filled implants may allow silicone to migrate

through the tissues. The relationship of free silicone to development or

progression of disease is unknown.

· Rupture is a device failure - the implant is no longer performing as

intended.

Protocol

· Women in this study were identified because they had been in a National

Cancer Institute study on women with breast implants. Women who responded

to a questionnaire in the NCI study were eligible for this study. This

cohort included only women who were patients at two plastic surgery

practices. The 907 women in this study were a subset of 1247 women in the

Birmingham, Ala., area who were part of an NCI study on breast implants.

· The rupture study had two parts. In the first part, 907 women were

interviewed about surgeries in which implant(s) were surgically removed

(interview component of the study).

· One third of the 907 women in the first part of the study reported that

they had at least one surgery in which their implant was removed and

replaced. Women were also asked the main reason they had their implants

removed, and if an implant rupture was suspected prior to the surgery.

· If women reported that their implant surgery was for a suspected implant

rupture, they were asked about symptoms that they may have had and about

whether the y knew of a possible cause of the rupture.o2

· In the second part of the study, 344 women with silicone gel breast

implants received MRI examinations to detect possible implant rupture. The

women, selected randomly from the first part of the study, were invited to

have MRI exams when they were called to be in the study until all the MRI

appointments planned for the study had been filled. The study had funding

for up to 400 MRI exams to be accomplished at a particular MRI facility

under contract for a certain period of time. Of the 445 women invited to

have an MRI, 80% (359) accepted and had the examination. Women were invited

for the MRI exam without regard to whether they had symptoms of breast

implant rupture. Those who accepted the appointments and came were no more

likely to think their breast implant was ruptured than women who declined

the examination or did not come to their appointments.

· The 344 women who received MRI examinations had a total of 687 implants.

The average age of the women in the MRI cohort was 51 ± 8 years. Most women

in this cohort had a single lumen gel breast implant (82%) and the

remainder had a double-lumen gel breast implant (silicone and saline). For

the 677 implants for which this information was available, the average

implant age was 17 ± 3 years.

· Three independent radiologists reviewed the results of all of the women's

MRIs and for each implant, determined whether it was intact, indeterminate

(suspicious for rupture), or ruptured. The agreement between the

radiologists was very high.

Results

· At least two of the three study radiologists agreed that 378 of the 687

implants were ruptured (55%). This means that 69% of the 344 women had at

least one ruptured breast implant.

· Radiologists observed that silicone gel had leaked outside the fibrous

scar capsule that forms around the implant in 85 of the 687 implants (12%).

Of the 344 women, 73 (21%) had silicone gel outside the capsule in one or

both breasts.

· Factors that were associated with rupture: the age of the implant, the

implant manufacturer, and whether the device was implanted above or beneath

the chest muscles.

Limitations of the Study

· This cohort included only women who were at two plastic surgery

practices. It is unknown whether the results of the study might have been

different if patients from other parts of the U.S. had been included.

· Only 80% of those invited to have an MRI examination agreed.

· Many types of silicone gel-filled breast implants were included in this

study.o3

· While MR imaging is considered the best method for imaging breast

implants for rupture, it is not perfect.

Conclusion

· MRI examination in this cohort of patients demonstrated that the majority

of women had at least one ruptured implant.

Funding and Authors

· Funding for this study came from: the Office of Women's Health, FDA; the

Office of the Commissioner; the National Cancer Institute, NIH; the Office

of Research on Women's Health, NIH; and the U.S. Department of Health and

Human Services. · Authors were S. Lori Brown, PhD, MPH 1 , S.

Middleton, PhD, MD 2 , Wendie A. Berg, MD, PhD 3 , Soo, MD 4 ,

and Gene Pennello, PhD 1 .

1 Office of Surveillance and Biometrics, Center for Devices and

Radiological Health, Food and Drug Administration, Rockville, MD 20850

2 Department of Radiology, University of California at San Diego School of

Medicine, San Diego, CA 92103

3 Division of Breast Imaging, Department of Radiology and Greenebaum Cancer

Center, University of land School of Medicine, Baltimore, MD 21201

4 Department of Radiology, Duke South Hospital, Duke University Medical

Center, Durham, NC 27710