High Complication Rates and Autoimmune Symptoms for Breast Implant Patients

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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. Diana

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.

 

 

 

 

 

Source: National Center for Policy Research for Women & Families

 

 

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