October 16, 2003
In a split decision, an advisory committee to the FDA recommended approval for Inamed’s silicone gel breast implants on October 15th. “The news is not good for breast implant patients, especially those with breast cancer,” noted Dr. Diana Zuckerman, President of the National Center for Policy Research for Women & Families, a Washington-based think tank. “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. The long-term risks remain unknown.”
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. “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)
Mammography — “The possibility that implants may delay cancer detection is of concern.” ( 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.”
The FDA advisory panel held their public meeting on October 14-15 in Gaithersburg, MD to decide whether to recommend Inamed’s silicone gel breast implants for FDA approval. All the plastic surgeons on the panel recommended approval. Most of the other doctors and scientists on the panel voted against approval, including a toxicologist, epidemiologist, statistician, radiologist, dermatologist, and cancer surgeon. The pediatric surgeon who chaired the panel only votes to break a tie, but stated publicly that he would have voted against approval.
Silicone gel breast implants have been available under FDA-imposed restrictions since 1992 because implant makers did not provide adequate research evidence that they were safe. The FDA is expected to make a final decision about whether or not to approve the implants within a few months.