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Amid rising concerns about the risk of “breast implant illness”, which involve wide-ranging health problems reported among women who received breast implants, federal regulators indicate that two manufacturers are failing in their duty to investigate and research their products.
This week, the FDA announced that it has sent warning letters to Mentor Worldwide LLC and Sientra, Inc., because they have failed to comply with premarket approval study requirements designed to assess the long-term risks of silicone breast implants.
According to the letters, Mentor conducted a post-approval study for its MemoryShape breast implant, but it had several serious deficiencies. The FDA indicates Mentor failed to enroll enough patients in the study, failed to follow up with patients adequately, and investigators found “significant data inconsistencies” in the study’s findings, such as missing race and ethnicity data.
Sientra’s study also had poor follow-up rates with patients, according to its warning letter, at only 61%. The company has been warned of the problem and has failed to address the agency’s concerns, the letter states.
A growing number of doctors are recognizing symptoms and problems in women with silicone implants as “breast implant illness,” commonly involving chronic side effects, such as fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues.
In many cases, the breast implant illness problems have led women to have the implants removed, and concerns about the risk have become a factor many are questioning whether to undergo breast enhancement or reconstruction surgery. However, the illnesses have not yet been scientifically verified, and the FDA has required breast implant manufacturers to investigate the potential side effects, particularly with silicone breast implants for several years. Both the Sientra and Mentor implants were approved in 2013, with the post-market approval study requirements.
“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” FDA Commissioner Scott Gottlieb said in the press release. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.”
The letters come just days before an FDA advisory committee hearing on breast implant risks and safety, scheduled for March 25 and 26.
Gottlieb first announced the meeting in late January, indicating that it will cover a range of topics on the benefits and risks of breast implants used for augmentation and reconstructive surgery.
While the advisory committees’ recommendations are not binding, the FDA usually weighs panel findings heavily when considering new regulations and guidance.
Breast Implant Concerns
In addition to the unexplained illnesses, problems have also emerged that suggest a link between breast implants and lymphoma that may develop in the tissue surrounding certain types of devices, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
On January 26, 2011, the FDA first released a report about case studies and epidemiological research, whcih suggested there was a link between breast implants and ALCL.
The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
Earlier this month the FDA sent a letter to healthcare providers indicating that there are now at least 457 confirmed breast implant lymphoma cases worldwide, with 246 new cases identified since September 30, 2017. That number includes at least nine deaths.
The agency urged doctors to become familiar with the signs of BIA-ALCL and to report suspected cases to the agency.
As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.
Product liability lawyers in the U.S. are now reviewing other potential breast implant cancer lawsuits for women diagnosed with ALCL in recent years, alleging that manufacturers knew or should have known about the risk, yet withheld warnings from consumers and the medical community.