FDA Panels Review Implant Studies
Written by Faith Anderson on September 1, 2011
Breast Implant Post-Market Studies Come up Short
According to a spokesperson for Mentor, Christopher Allman, since launching the post-approval studies, the company has stressed the importance of follow-up to both the women receiving the implants and their doctors. Unfortunately, Allman laments, it still remains a challenge. “At Mentor’s request, letters from the FDA were sent to physicians and patients to encourage follow-up and state the importance of follow-up; unfortunately, there was minimal impact with respect to the follow-up rate,” Allman says. Allergan’s study enrolled more than 39,300 women with a follow-up rate of 60% after two years. Mentor enrolled over 40,000 women with a follow-up rate of only 21% after three years.
Patient Experience With Silicone Breast Implants
During an open public comment session, some patients recounted the horrors they have experienced with silicone implants; some implored manufacturers to make sure future studies are well-designed and protect women. Susan Dorsey from Mount Juliet, Tennessee, replaced her saline implants with silicone six years ago and enrolled in Allergan’s study. Her symptoms began within months of receiving the silicone implants and included “blurry vision, tingling, loss of appetite, insomnia, joint pain, anxiety, [and] dizziness.” She also had difficulty raising her arms over her head and exhibited flu-like symptoms, and neck and shoulder pain that forced her to undergo physical therapy three times a week.
Carolyn Wolfe of Virginia had her implants for 28 years and experienced a variety of symptoms. Three years ago, she was told she had connective tissue disease, chronic obstructive pulmonary disease, chronic fatigue, asthma and irritable bowel syndrome. After having an MRI, Wolfe was found to have 20 lesions on her brain and two collapsed implants with very little silicone left inside, which she had removed. Wolfe demands, “Is the FDA willing to publicly state that silicone and platinum leaking into women’s bodies year after year is safe?” On the other hand, Nicole Noel told the FDA panel that she would be getting silicone implants for a second time after giving birth to her second child. “After having two children I had lost all volume. I had no breast tissue. I have more self-confidence and am more proportional,” Noel claims.
Proposed Enforcement Procedures for Silicone Breast Implants
As Dr. Susan Wood sees it, safety data for silicone breast implants has, time and time again, come up short. “For more than 20 years, the FDA has been asking manufacturers to conduct and report rigorous studies on the safety and effectiveness of breast implants. This committee is now very aware of the limitations of the current post-approval studies.” Wood believes that real enforcement procedures need to be put in place, including consideration of withdrawal of approval, significant financial penalties, major labeling or patient information changes, and requirements for sponsor-funded but independent research conducted for these studies. However, Jeffrey Kenkel, professor and vice chairman of the Department of Plastic Surgery at the University of Texas, Southwestern Medical School at Dallas, and president of the American Society of Aesthetic Plastic Surgery (ASAPS), argues that the implants are still safe and effective, and that there are plenty of well-designed studies that can support that claim.
Advocates vs. Opponents of Silicone Implants
According to Kenkel, FDA measures established five years ago are difficult because a study with 40,000 participants is hard to track. “Multi-investigators have a difficult time getting patients who are feeling well and back to their normal routine after surgery to come back in for their follow-up,” Kenkel claims. Susan Dorsey says she had a very different experience, however. Dorsey told the FDA panel that she was “forced out” of the Allergan study when she decided to remove the silicone implants to save her life. “All of my records were deleted – as if I never existed.” According to Dr. Edward Melmed, a plastic surgeon from Dallas, silicone implants are an “industrial toxin.” According to Melmed, at ten years following implantation, 50% of silicone implants rupture, 72% rupture by 15 years, and 94% rupture by 20 years. Melmed implores, “Why is the FDA continuing to allow a device to be placed in young women that is guaranteed to fail 80% in ten years?”
FDA Considerations for the Future of Post-Approval Studies
According to ASAPS, over 318,000 breast augmentations were were conducted in 2010 – more than any other surgical procedure – and sixty-two percent of those procedures were silicone breast implants. In the future, the FDA says it will see the current studies completed, make sure follow-up rates improve, and will look into the creation of a breast implant registry, which may be implemented on an international scale. FDA spokeswoman Erica Jefferson says the FDA has a lot to consider following the FDA panels’ reviews of Allergan and Mentor’s studies. According to Jefferson, the FDA’s next step will be to review the recommendations and outline the suggestions they think should be implemented in the future. They plan to engage stakeholders, including patients, professional groups, sponsors, consumers groups and academia, before making any decisions.