Women Who Undergo Reconstructive Breast Implantation Frequently Develop Short-term Complications

[Guest guest]

Would the FDA approve any other device/medication with

such a high rate of complications?

http://www.sciencedaily.com/releases/2006/01/060102123555.htm

Source: JAMA and Archives Journals

Date: 2006-01-02

Women Who Undergo Reconstructive Breast Implantation

Frequently Develop Short-term Complications

Almost one-third of women who underwent reconstructive

breast implantation after mastectomy had at least one

short-term complication in the chest or breast area,

with one in five women requiring additional surgery,

according to a study in the December issue of Archives

of Surgery, one of the JAMA/Archives journals.

Breast cancer is the most common malignancy among

women in North American, Europe, Australia, New

Zealand and some parts of South America, according to

background information in the article. Women with

breast cancer and their physicians may face several

choices in the course of treatment, including whether

to remove the breast (mastectomy) or undergo

breast-conserving therapies, when and whether to

reconstruct the breast following mastectomy and what

materials to use in doing so. Surgeons performing

postmastectomy reconstruction can form the new breast

from flaps of skin and other tissue from the woman's

body (autologous tissue) or insert an implant, and

sometimes use both techniques at once. Many women

choose implants alone because the procedure is simpler

and requires less operation time than those using

autologous tissue, and it can preserve the color of

the skin of the breast and possibly some of its

sensitivity.

Trine F. Henrikson, M.D., of the Danish Registry for

Plastic Surgery of the Breast (DPB), Copenhagen,

Denmark, and colleagues analyzed data from 574 women

in the registry who underwent postmastectomy breast

reconstruction between June 1, 1999, and July 24,

2003. The patients' surgeons reported the dates and

details of each implantation and filled out follow-up

forms when the women returned for subsequent visits.

The women, ages 21 to 78 years with a mean (average)

age of 51 years, were monitored through Sept. 15,

2003.

Following their first implantation, 31 percent of the

women developed at least one adverse event, 16 percent

developed two complications and 8 percent experienced

three or more during the course of the study. The most

common complications were infection, blood clotting,

seroma (collection of serum in the tissues) and skin

perforation. Forty-nine percent of these complications

occurred within three months and 67 percent within six

months.

Additional surgery was required for 21 percent of the

women, while 3 percent underwent additional

nonsurgical treatment. Surgery was most often needed

to correct asymmetry of the breasts, displacement of

the implant or capsular contracture, when the

capsule-like scar tissue that forms around the implant

tightened and hardened. " Surgical or medical

intervention is commonly required during the

reconstructive course, but reconstruction failure

(loss of implant) is rare, " the authors report.

The researchers also examined data on the 302 women in

the study who had reimplantations, usually to exchange

or replace the existing implant. These women had

similar rates of complications--36 percent of them

developed at least one adverse event and 21 percent

required additional surgery.

" When evaluating benefits and risks associated with

breast reconstruction, the surgeon and patient should

consider that the reconstructive process often

requires additional surgical interventions to treat

local complications or to achieve the desired cosmetic

result, " the authors conclude. " Detailed information

on the likelihood of local complications associated

with the given indication (cosmetic vs.

reconstructive) should be an essential part of

adequate informed consent for women seeking breast

implantation. "

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(Arch Surg. 2005;140:1152-1159. Available pre-embargo

to the media at www.jamamedia.org.)

Editor's Note: This study was funded by the

International Epidemiology Institute, which received

unrestricted funding for the DPB from the Dow Corning

Corporation, Midland, Mich.