A study published in the Annals of Surgery on September 14, 2018 entitled, “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients” concluded: “Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.”
Breast implants are used in nearly 300,000 augmentations and in 100,000 reconstructions annually in the United States. The U.S. Food and Drug Administration’s (“FDA”) database of large postapproval studies (“LPAS”) prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from two manufacturers, Allergan and Mentor, placed for primary/revision augmentation/reconstruction. The LPAS are summarized by operative indication and manufacturer. Allergan enrolled 41,342 patients with silicone implants and 15,646 with saline implants. Mentor enrolled 41,975 with silicone implants and 1,030 with saline implants. Fifty-six percent (56%) of the patients received silicone implants for primary augmentation. Overall, 72% of patients underwent primary augmentation, 15% revision augmentation, 10% primary reconstruction, and 3% revision reconstruction.
The study reported that the manufacturers reported that more symptoms are experienced by patients with silicone implants compared to saline implants. Allergan reported higher standard incidence ratios were observed in the revision-reconstruction cohort for scleroderma, Sjogren’s syndrome, and dermatomyositis/polymyositis at 7 years, without quantification. Allergan also reported approximately 500 possible rheumatologic events in silicone versus less than 5 events in saline, and some symptoms occurred more frequently in the silicone cohort compared to the saline cohort, even after an age-adjusted analysis. Mentor reported significant increases for fatigue, exhaustion, joint swelling, joint pain, numbness of hands, frequent muscle cramps, and the combined categories of fatigue, pain, and fibromyalgia-like symptoms in primary augmentation patients, and for joint pain in revision-augmentation patients, which increases were not found to be related to simply getting older over time.
The study found no association between breast implants and suicide.
The study reported that in primary augmentation 1.7% of patients undergo reoperation; in reconstruction, reoperation is between 24.7% and 26.6%. The study found altogether, 35.9% of primary augmentations and between 50.8% and 58.5% of revision augmentations, primary/revision reconstructions will experience some degree of morbidity in the form of a complication and/or reoperation. Surgeons report that capsular contracture is confirmed to be the greatest long-term source of morbidity and reoperation.
If you or a loved one have or had silicone breast implants and suffered unexpected harm as a result, you may be entitled to compensation for the harm you suffered, including but not limited to reimbursement for medical expenses and losses associated with reoperation or removal of your silicone breast implants. Sometimes the harm suffered is due to the silicone implants themselves, and sometimes the harm may be due to the medical negligence of the implant surgeon.
If you or a loved one may have been harmed by silicone breast implants, you should promptly find a medical malpractice lawyer (silicone breast implant lawyer or medical device lawyer) in your U.S. state who may investigate your claim for you and represent you in a silicone breast implant claim, if appropriate.
Visit our website or call us toll-free in the United State at 800-295-3959 to find lawyers in your state who may assist you.
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