FDA Panel Calls for Further Study of Silicone Breast Implants

Safety studies of silicone gel breast implants will continue, and despite concerns about their safety, the controversial devices will be permitted to stay on the market, the U.S. Food & Drug Administration (FDA) announced yesterday. The announcement came after an outside expert advisory panel to the FDA stated that the implants should not be treated as “lifetime devices,” citing high re-operation rates and complications such as breast hardening and implant rupture, according to a report in WebMD.

In addition to complications such as hardening and rupture, studies have pointed to an association between breast implants – both silicone and saline – and a rare form of non-Hodgkin’s lymphoma called <"http://www.yourlawyer.com/topics/overview/Breast-Implant-ALCL-Lymphoma-Anaplastic-Large-Cell-Lymphoma-Lawsuit-Lawyer">anaplastic large cell lymphoma (ALCL). Concerns about a possible link between breast implants and ALCL were first raised in 1996, following publication of a report describing a woman with implants who developed the cancer in tissue located next to one of her implants. Since then, similar reports have been published, and it is estimated that one in three women with breast implants—silicone or saline—will develop ALCL.

As we’ve reported previously, the FDA warned in January that 60 cases of ALCL have been reported in silicone and saline breast implant patients. The agency also said its review of the medical literature published between January 1997 and May 2010 revealed 34 unique cases of ALCL. Twenty-seven cases of the lymphoma involved silicone breast implants, while most were diagnosed after silicone implants returned to the market in 2006. The diagnoses tended to occur a median of eight years after implantation, and involved implants for breast augmentation as opposed to reconstruction following breast cancer surgery.

Despite these and other safety concerns, the FDA will allow silicone gel breast implants to remain on U.S. market to give implant makers the chance to increase the participation rates needed for long-term safety studies, said an FDA official. The studies lost many of the women they were meant to be following, said Web MD. Because of this, valid conclusions about risk are likely impossible, an issue given that when the FDA permitted silicone gel breast implants to return to the market in 2006, a condition for approval was that breast implant makers conduct more clinical trials to oversee complication rates and other long-term problems, noted WebMD.

In addition to ALCL, other potential adverse reactions that the agency and patient advocates want to see monitored are connective tissue diseases (lupus, rheumatoid arthritis, and scleroderma), nerve problems, cancer, suicide, mammogram interference, issues with babies born to mothers with breast implants, and women with implants who might have had trouble becoming pregnant or breastfeeding, said WebMD.

The original studies were meant to enroll over 82,000 women with silicone and 16,000 women with saline implants for comparison with studies intended to follow the participants for a decade, explained WebMD. Instead, three years into the research, Memory Gel implant maker, Mentor, lost 79 percent of their enrolled patients and Allergan, which makes Natrelle implants, lost about 40 percent of their patients after two years. The studies, according to experts, are less able to detect the adverse events they were meant to reveal.

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