Silicone breast implants get attention in more ways than one
Sep 08, 2011 Posted by Martha Drezin
FDA panel looks for ways to improve patient compliance
Silicone-gel breast implants are in the news again and here’s why: In 2006, the FDA put silicone implants back on the market following a hiatus of 14 years. But there was a catch. The FDA required implant makers, Mentor and Allergan, to perform long term studies following up on droves of newly buxom recipients. But, unfortunately, satisfied patients have taken their cleavage and fled. Compliance with follow-up questionnaires has ranged from poor to lousy.
Nonetheless, after two days of discussion about how to improve silicone breast implant study compliance, Dr. William Maisel, chief scientist for the FDA, reaffirmed that silicone breast implants are safe.
According to a CNN article, Dr. Jeffrey Kenkel, president of the American Society of Aesthetic Plastic Surgery, says there are a number of well-designed studies that document the safety and efficacy of breast implants. "I think both ASAPS as well as the FDA are confident that breast implants are safe and effective. We're fortunate that we have a very high patient satisfaction rate - above 90%. Ninety percent of breast implant patients are happy with their outcome and report an improved quality of life and body image."
But the major players, including sponsors, professional groups, patients and physicians are wringing their hands in frustration and doing some finger pointing. The one thing they all agree on is that FDA-mandated studies have yielded inadequate follow-up on the thousands of women who received silicone implants.
But this is not for lack of trying. Both Mentor and Allergan each enrolled about 40,000 patients. But according to msnbc.com, “Mentor has three-year data for only one out of five women in its study, while Allergan has two-year data for three out of every five.” Since follow-up was a condition of FDA approval, silicone breast implants are back under the microscope, much to the dismay of many women who prefer silicone to saline because saline implants can ripple.
FDA-generated letters to plastic surgeons and patients, stressing the importance of follow-up, had minimal impact on patients who simply did not comply. There are plausible reasons for noncompliance, but no excuses. How can we create a safe health environment for our daughters if we are unwilling to take the time to participate in a study deemed mandatory by a regulatory body such as the FDA?
During the recent panels and testimony about silicone breast implants, reasons for lack of follow-up were suggested. Multiple plastic surgeons talked about how hard it is to get patients who are feeling well and who are happy with their new breasts to come back in for their follow up.
The patients you do hear from are the ones with complications. Susan Dorsey, Mount Juliet, Tennessee, reported flu-like symptoms, neck and shoulder pain, blurry vision and a host of other problems within months of receiving silicone implants. According to CNN, “Carolyn Wolfe, from Virginia, was found to have connective tissue disease, chronic fatigue and asthma and after 28 years of having silicone implants. An MRI revealed 20 lesions on her brain and two collapsed implants with very little silicone left inside.” Had Wolfe undergone an MRI every two years to screen for silent ruptures, as recommended by the FDA, her problems could have been averted. Saline implants deflate when they tear, silicone implants do not; so imaging is vital to ensure that implants are intact.
But, now, MRI screening is also being debated. MRI is expensive, which can be a deterrent, and some express concern about false positive readings. According to the New York Times, there was consensus among the panel that requirements for ongoing MRI’s be removed as a condition for participating in clinical studies. The FDA continues to support MRI as the gold standard for detecting silent rupture and the jury is still out about whether they will follow the panel’s advice.
Consumer advocate Dana Casciotti suggested that the annual 27-page questionnaire study participants were asked to complete should be shortened and simplified. Given the demands of everyday life, you can’t argue with that.
Finally, money talks. A stipend for compliance was suggested. Some said that patients should be paid for participating and others said that doctors should also be paid. Interestingly, Allergan, which had a 60 percent follow-up rate with patients after two years, paid women a small sum of money for filling out questionnaires and complying with scheduled office visits. Mentor, with their lower compliance rate, did not offer a monetary reward.
Kudos to Dr. Dennis Hammond from Grand Rapids, Michigan! He designated one staff member to follow-up with women in the clinical trial and he devoted a half day of clinical time each week to seeing women in the study for follow-up visits. Results: he kept track of about 76% of his silicone breast implant patients.
The FDA is committed to seeing that the current studies are completed, making sure that follow-up rates improve and will look into creation of a breast implant registry, possibly on an international scale. They will continue to enlist feedback from implant makers, professional groups, patients, consumer groups and academia.
Efforts will be in vain unless the thousands of ladies, who went from pancakes to melons, speak up and comply with studies. Granted, those 27-page forms are too long, you’re ready to forget your surgery and move on and your new twin endowments may be the cause an overwhelming flood of male attention. But, what about your daughters? Women need to know, unequivocally, that silicone breast implants are a healthy choice. Enjoy the rewards of your new décolletage, but take time out to visit your plastic surgeon and follow-up with long-term studies.
Silicone-gel breast implants are in the news again and here’s why: In 2006, the FDA put silicone implants back on the market following a hiatus of 14 years. But there was a catch. The FDA required implant makers, Mentor and Allergan, to perform long term studies following up on droves of newly buxom recipients. But, unfortunately, satisfied patients have taken their cleavage and fled. Compliance with follow-up questionnaires has ranged from poor to lousy.
Nonetheless, after two days of discussion about how to improve silicone breast implant study compliance, Dr. William Maisel, chief scientist for the FDA, reaffirmed that silicone breast implants are safe.
According to a CNN article, Dr. Jeffrey Kenkel, president of the American Society of Aesthetic Plastic Surgery, says there are a number of well-designed studies that document the safety and efficacy of breast implants. "I think both ASAPS as well as the FDA are confident that breast implants are safe and effective. We're fortunate that we have a very high patient satisfaction rate - above 90%. Ninety percent of breast implant patients are happy with their outcome and report an improved quality of life and body image."
But the major players, including sponsors, professional groups, patients and physicians are wringing their hands in frustration and doing some finger pointing. The one thing they all agree on is that FDA-mandated studies have yielded inadequate follow-up on the thousands of women who received silicone implants.
But this is not for lack of trying. Both Mentor and Allergan each enrolled about 40,000 patients. But according to msnbc.com, “Mentor has three-year data for only one out of five women in its study, while Allergan has two-year data for three out of every five.” Since follow-up was a condition of FDA approval, silicone breast implants are back under the microscope, much to the dismay of many women who prefer silicone to saline because saline implants can ripple.
FDA-generated letters to plastic surgeons and patients, stressing the importance of follow-up, had minimal impact on patients who simply did not comply. There are plausible reasons for noncompliance, but no excuses. How can we create a safe health environment for our daughters if we are unwilling to take the time to participate in a study deemed mandatory by a regulatory body such as the FDA?
During the recent panels and testimony about silicone breast implants, reasons for lack of follow-up were suggested. Multiple plastic surgeons talked about how hard it is to get patients who are feeling well and who are happy with their new breasts to come back in for their follow up.
The patients you do hear from are the ones with complications. Susan Dorsey, Mount Juliet, Tennessee, reported flu-like symptoms, neck and shoulder pain, blurry vision and a host of other problems within months of receiving silicone implants. According to CNN, “Carolyn Wolfe, from Virginia, was found to have connective tissue disease, chronic fatigue and asthma and after 28 years of having silicone implants. An MRI revealed 20 lesions on her brain and two collapsed implants with very little silicone left inside.” Had Wolfe undergone an MRI every two years to screen for silent ruptures, as recommended by the FDA, her problems could have been averted. Saline implants deflate when they tear, silicone implants do not; so imaging is vital to ensure that implants are intact.
But, now, MRI screening is also being debated. MRI is expensive, which can be a deterrent, and some express concern about false positive readings. According to the New York Times, there was consensus among the panel that requirements for ongoing MRI’s be removed as a condition for participating in clinical studies. The FDA continues to support MRI as the gold standard for detecting silent rupture and the jury is still out about whether they will follow the panel’s advice.
Consumer advocate Dana Casciotti suggested that the annual 27-page questionnaire study participants were asked to complete should be shortened and simplified. Given the demands of everyday life, you can’t argue with that.
Finally, money talks. A stipend for compliance was suggested. Some said that patients should be paid for participating and others said that doctors should also be paid. Interestingly, Allergan, which had a 60 percent follow-up rate with patients after two years, paid women a small sum of money for filling out questionnaires and complying with scheduled office visits. Mentor, with their lower compliance rate, did not offer a monetary reward.
Kudos to Dr. Dennis Hammond from Grand Rapids, Michigan! He designated one staff member to follow-up with women in the clinical trial and he devoted a half day of clinical time each week to seeing women in the study for follow-up visits. Results: he kept track of about 76% of his silicone breast implant patients.
The FDA is committed to seeing that the current studies are completed, making sure that follow-up rates improve and will look into creation of a breast implant registry, possibly on an international scale. They will continue to enlist feedback from implant makers, professional groups, patients, consumer groups and academia.
Efforts will be in vain unless the thousands of ladies, who went from pancakes to melons, speak up and comply with studies. Granted, those 27-page forms are too long, you’re ready to forget your surgery and move on and your new twin endowments may be the cause an overwhelming flood of male attention. But, what about your daughters? Women need to know, unequivocally, that silicone breast implants are a healthy choice. Enjoy the rewards of your new décolletage, but take time out to visit your plastic surgeon and follow-up with long-term studies.