Inamed Research Shows High Complication Rates and Autoimmune Symptoms for Breast Implant Patients

[Guest guest]

Source: National Center for Policy Research for Women

& Families

Inamed Research Shows High Complication Rates and

Autoimmune Symptoms for Breast Implant Patients

Saturday October 11, 3:20 am ET

Poor Research Follow-up, Potentially Toxic Metals Also

Noted by FDA

WASHINGTON, Oct. 11 /PRNewswire/ -- The following

press release was issued today by the National Center

for Policy Research for Women & Families:

In its efforts to win FDA approval for silicone gel

breast implants at hearings to be held on October 14th

and 15th, implant manufacturer Inamed submitted

hundreds of pages of research information from three

studies. However, the news is not good for breast

implant patients, especially those with breast cancer.

Released by the FDA October 10th, the company's own

research indicates high complication rates for the

first three years, including the need for additional

surgery for 46% of breast cancer patients.

Inamed's " Core " study included 221 breast cancer

reconstruction patients, 494 augmentation patients,

and 225 revision (replacement) patients. According to

the FDA, their complication rates are very high. For

example, 46% of reconstruction patients underwent at

least one re-operation within 3 years, 25% had removal

or replacement, 6% had a diagnosed ruptured implant,

6% had breast pain, and 6% were diagnosed with

necrosis, a painful and disfiguring condition where

the skin or tissue dies. Complications were lower but

still substantial for augmentation patients (for

example, 21% with re-operations, and 1% diagnosed

rupture) and revision patients (33% with re-operations

and 4% diagnosed ruptures). The FDA assumed that the

rupture rate was higher than reported, since three out

of four ruptures would not be diagnosed unless a woman

underwent an MRI.

The largest study, called the Adjunct Study, enrolled

15,465 reconstruction patients and 9,881 " revision "

patients (who had replaced their previous breast

implants with new Inamed silicone gel implants). The

Adjunct Study was the compromise developed by the FDA

to enable large numbers of mastectomy patients and

women with broken gel implants to use silicone gel

implants at a time when the company had not proven

that their product was safe. Although women wanting

silicone breast implants were required to participate

in the Adjunct Study, the company apparently made

little effort to comply with this requirement: barely

half (54%) of the breast cancer patients who received

Inamed implants stayed in the study for one year. Even

fewer -- 27% -- stayed in the study for three years.

Women who wanted silicone gel implants to replace

broken gel implants were also required to participate

in the Adjunct Study, but they were even less likely

to stay in the study than breast cancer patients. Less

than half (44%) stayed in the study for one year and

only one in five (20%) stayed for three years.

" Most women did not stay in these studies for even one

year, making the largest study useless in determining

whether the implants are safe " explains Dr.

Zuckerman, president of the National Center for Policy

Research for Women & Families. " Inamed was told that

they were supposed to study the safety of implants as

a condition of sale. The main concern about silicone

implants is the health risks when they break, but the

company did not study women long enough to find out

what those risks are. "

Inamed also gathered data about health symptoms

experienced by their patients. In the FDA review of

Inamed's data, FDA scientists noted the following:

-- Muscle pain, joint pain, hair loss, rashes,

and fatigue all increased within two years of getting

implants.

-- In terms of their quality of life, almost

every measure of emotional and physical health,

including social interactions and self-esteem,

declined within two years of getting implants. The

improvements were in self-reported sexual

attractiveness.

In its description of the components of the implant

shell, the FDA noted the presence of 24 potentially

toxic metals, including arsenic, lead, mercury, and

platinum. (FDA Review Team Memo, p. 9)

In its review of scientific studies conducted by other

researchers, FDA scientists noted:

Cancer -- " The finding of excesses in lung (or

respiratory), cervical, vulvar, and leukemia have been

reported in more than one study. These findings are

difficult to interpret, and further research is needed

to clarify this issue. " (FDA Review Team Memo, p. 35)

(slide #100)

Mammography - " The possibility that implants may

delay cancer detection is of concern. " (Id p. 38)

Silicone Migration - " Cases of distant migration

of gel to breasts, axillary lymph nodes, abdomen,

groin, arm, and fingers have been reported, some with

serious consequences and deformities... " (FDA Review

Team Memo, p. 37)

Inamed also reported results from a 5-year study

started in 1990, but it included only 29

reconstruction patients. The study started with 547

augmentation patients, but most were not studied for

all five years. Since most of the patients dropped out

of the study and most had breast implants that the

company is no longer selling, results from this study

were not useful.

" The findings show many areas of concerns and

unanswered safety questions, and provide worrisome

evidence that women with silicone gel implants will

face numerous complications directly related to the

implants, symptoms such as pain and fatigue, and

declines in health and mental health, " concludes Dr.

Zuckerman. " Although the rupture rate is low during

the first two years, it is expected to increase every

year, as it has in other studies. "

An FDA advisory panel will hold a public meeting on

October 14-15 in Gaithersburg, MD to decide whether to

recommend Inamed's silicone gel breast implants for

FDA approval. All silicone gel breast implants have

been available under FDA-imposed restrictions since

1992 because the manufacturers did not provide

adequate research evidence that they were safe.

CPR for Women & Families is a nonprofit think tank

that uses research information to improve health and

safety of women, children, and families.

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Source: National Center for Policy Research for Women

& Families